<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02990364</url>
  </required_header>
  <id_info>
    <org_study_id>SUR.YE.01</org_study_id>
    <nct_id>NCT02990364</nct_id>
  </id_info>
  <brief_title>Combination Analgesia for Neonatal Circumcision</brief_title>
  <official_title>Analgesia for Neonatal Circumcision: A Randomized Controlled Clinical Trial of EMLA Versus Combination of EMLA, Sucrose and Dorsal Penile Nerve Block or Ring Block</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>American University of Beirut Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>American University of Beirut Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Circumcision is a commonly performed procedure on newborn males. Clear recommendations and/or&#xD;
      guidelines for pain control during the procedure do not exist. The purpose of this research&#xD;
      is to compare various forms of analgesia to evaluate which is the more effective for pain&#xD;
      reduction. The investigators hope that this study can provide definitive guidelines on the&#xD;
      best form of analgesia to use during circumcision. It is important that we perform this study&#xD;
      to ensure that in the future newborns' pain during circumcision is effectively managed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Procedure/Interventions/Drugs Several forms of analgesia, including local anesthetic creams&#xD;
      or local anesthetics administered by injection, will be compared as methods of pain control&#xD;
      during circumcision. All of these analgesics have already been used for intra-operative pain&#xD;
      control during circumcision. The drugs that will be used in the study are all local&#xD;
      anesthetics of the amino-amide group, and include lidocaine and prilocaine. Because there is&#xD;
      no consensus on the best anesthetic for circumcision, the investigators propose a comparative&#xD;
      study. Children taking part in this research will be put into groups which are selected by&#xD;
      chance. There will be three different groups. One of the groups will serve as a control&#xD;
      group, and in the three other groups combinations of anesthetics will be tested. The control&#xD;
      group will be receiving the usual anesthetic used in the normal nursery for pain control&#xD;
      during circumcision, while the combination groups will be receiving additional anesthetic&#xD;
      agents. Randomization to groups will be done using a random sequence generator. The&#xD;
      intervention for each patient will then be placed in a sealed envelope, and will be opened by&#xD;
      the individual performing the circumcision at the time the procedure is scheduled.&#xD;
&#xD;
      The following interventions will be used:&#xD;
&#xD;
      EMLA Topical Product:&#xD;
&#xD;
      EMLA cream is a eutectic mixture of 2.5% lidocaine and 2.5% prilocaine, used as a topical&#xD;
      anaesthetic to diminish pain from cutaneous procedures. Seventy minutes prior to&#xD;
      circumcision, the newborn will be placed in the circumcision mold with the legs restrained,&#xD;
      and attached to a monitor. 1 gram of EMLA cream will be applied by the nurse to the penis&#xD;
      using a syringe and then wrapped with a dressing (Tegaderm). After sixty minutes they will be&#xD;
      returned to the circumstrep, reattached to the monitor, and legs will be restrained. The&#xD;
      Tegaderm and drug will be removed, and the infant will be left to settle then the&#xD;
      circumcision will take place.&#xD;
&#xD;
      Dorsal Penile Nerve Block (DPNB):&#xD;
&#xD;
      Dorsal penile nerve block is an anesthetic technique first described in 1978, and has since&#xD;
      then been extensively evaluated in the management of pain during circumcision. DPNB will be&#xD;
      done with 1% lidocaine without epinephrine injected at two sites at the base of the penis (2&#xD;
      and 10 o'clock). Ten minutes prior to circumcision, the newborn will be placed in the&#xD;
      circumcision mold with legs restrained, and attached to a monitor. A total of 2 mg/kg of 1%&#xD;
      lidocaine without epinephrine will be used to perform the block, and equal aliquots in&#xD;
      milliliters will be injected at the two sites at the base of the penis. The block will be&#xD;
      done by the circumciser. Five minutes after the block the circumcision will be performed.&#xD;
&#xD;
      Ring Block:&#xD;
&#xD;
      Ring block is another anesthetic technique described in the 1990s that has also been examined&#xD;
      for pain control during circumcision. Ring block will be done with 1% lidocaine without&#xD;
      epinephrine injected in a band around the penis halfway along the shaft. Ten minutes prior to&#xD;
      circumcision, the newborn will be placed in the circumcision mold with the legs restrained,&#xD;
      and attached to a monitor. A total of 2 mg/kg of 1% lidocaine without epinephrine will be&#xD;
      used to perform the ring block and will be injected in a band around the penis. The block&#xD;
      will be done by the circumcising physician. Five minutes later the circumcision will be&#xD;
      performed.&#xD;
&#xD;
      Intervention groups:&#xD;
&#xD;
      Control group: (1) EMLA Combination Groups: (2) EMLA + Sucrose (3) EMLA + Ring Block +&#xD;
      Sucrose; (4) EMLA + Sucrose + DPNB For all groups the same procedures detailed above for&#xD;
      EMLA, DPNB, and ring block will be followed depending on patient grouping.&#xD;
&#xD;
      General:&#xD;
&#xD;
      EMLA will be used on all patients.&#xD;
&#xD;
      Videotaping:&#xD;
&#xD;
      In order to ensure that the study is properly blinded, video-taping of the procedure will&#xD;
      need to take place. A video camera will be set to capture the infant's face and torso and the&#xD;
      monitor, but not the individual performing the circumcision. The videos will be labeled&#xD;
      numerically, and not by patient name. Videos will be viewed by two other individuals (not&#xD;
      present at the circumcision itself and not responsible for obtaining consent), and a possible&#xD;
      third viewer may be required to resolve conflicting opinions. The video tapes will not be&#xD;
      seen by any other individual, and will only be for data collection and pain scoring. They&#xD;
      will be kept in the possession of the two principal investigators in a locked drawer in their&#xD;
      offices at all times. The video tapes will be destroyed after the completion of the study.&#xD;
&#xD;
      Outcomes:&#xD;
&#xD;
      The primary outcome variable will be the pain score. Pain scores consist of behavioral&#xD;
      components of the infant such as facial expression, crying, breathing patterns, arm movement,&#xD;
      and leg movement. Secondary outcomes will include effects on heart rate, crying time, and&#xD;
      oxygen saturation (obtained from the monitor).&#xD;
&#xD;
      Patients' participation can be ended at any time by the investigator. Significant new&#xD;
      findings will be conveyed to the parents of the newborn.&#xD;
&#xD;
      Risks&#xD;
&#xD;
      The main risks of participation in the study are:&#xD;
&#xD;
        1. the adverse effects that might result from circumcision itself, such as pain, bleeding,&#xD;
           surgical trauma, local infections, and meatal stenosis.&#xD;
&#xD;
        2. adverse effects that may result from drugs, such as allergic reactions&#xD;
&#xD;
        3. adverse effects that might result from specific drug administration technique, EMLA may&#xD;
           result in methemoglobinemia and local skin reactions such as blanching, edema, and&#xD;
           erythema. DPNB and ring block may result in bruising, bleeding, and hematomas at the&#xD;
           injection site.&#xD;
&#xD;
        4. adverse effects if the anesthetic is erroneously injected systemically.&#xD;
&#xD;
      Although the investigators have taken steps to minimize the risks of this study, there may&#xD;
      also be unforeseeable risks.The parents may choose to withdraw consent at any time during the&#xD;
      study.&#xD;
&#xD;
      Benefits All the anesthetics that will be used in the study have already been shown to play a&#xD;
      role in pain reduction during circumcision, however some seem to be more effective than&#xD;
      others. The participating child will directly benefit from the study, since his pain will be&#xD;
      controlled to some extent during the circumcision procedure. Furthermore, if the study&#xD;
      provides conclusive evidence about the most effective method of analgesia, then guidelines&#xD;
      can be instituted so that in the future all newborns will have their pain successfully&#xD;
      controlled during the procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2015</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Neonatal Infant Pain Scale (NIPS)</measure>
    <time_frame>During Circumcision, at 1 hour intervals for 4 hours after circumcision and for blinded evaluation</time_frame>
    <description>The Neonatal Pain Scale (NIPS) is a behavioral assessment tool for measurement of pain in preterm and full-term neonates. This can be used to monitor a neonate before, during and, after a painful procedure such as venipuncture. It was developed at the Children's Hospital of eastern Ontario.&#xD;
Parameters:&#xD;
Facial Expression&#xD;
Cry&#xD;
Breathing Pattern&#xD;
Arms&#xD;
Legs *&#xD;
State of arousal&#xD;
The Legs parameter was removed for this study, as the legs are not shown in the video and are tied to the circumcision table during the operation. Moreover, following the circumcision the infants are tucked in via blankets that restrict leg movement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart Rate</measure>
    <time_frame>During Circumcision, at 1 hour intervals for 4 hours after circumcision and for blinded evaluation</time_frame>
    <description>Effects on heart rate, measured by beats/minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Crying Time</measure>
    <time_frame>During Circumcision, at 1 hour intervals for 4 hours after circumcision and for blinded evaluation</time_frame>
    <description>Crying time, measured in seconds using a stop watch.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen Saturation</measure>
    <time_frame>During Circumcision, at 1 hour intervals for 4 hours after circumcision and for blinded evaluation</time_frame>
    <description>Oxygen Saturation measured in percent</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Analgesia</condition>
  <arm_group>
    <arm_group_label>Control: EMLA Topical Product</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This represents the control group and it is the traditional analgesic used for circumcisions.&#xD;
EMLA cream is a eutectic mixture of 2.5% lidocaine and 2.5% prilocaine, used as a topical anaesthetic to diminish pain from cutaneous procedures. Seventy minutes prior to circumcision, the newborn will be placed in the circumcision mold with the legs restrained, and attached to a monitor. 1 gram of EMLA cream will be applied by the nurse to the penis using a syringe and then wrapped with a dressing (Tegaderm). After sixty minutes the Tegaderm and drug will be removed, and the infant will be left to settle until the circumcision.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EMLA + Sucrose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>There is high-quality evidence for the beneficial effect of sucrose (24%) with non-nutritive sucking (pacifier dipped in sucrose) or 0.5 mL of sucrose orally in preterm and term infants. To assess this, 10 ml of sucrose (24%) will be given to the infant during the course of the circumcision.&#xD;
In combination to the EMLA cream, the infant will be given sucrose during the circumcision to test the effects of sucrose and sucking on pain management.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EMLA + Sucrose + Ring Block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ring block will be done with 1% lidocaine without epinephrine injected in a band around the penis halfway along the shaft. Ten minutes prior to circumcision, the newborn will be placed in the circumcision mold with the legs restrained, and attached to a monitor. A total of 2 mg/kg of 1% lidocaine without epinephrine will be used to perform the ring block and will be injected in a band around the penis. The block will be done by the circumciser.&#xD;
In combination with the ring block, EMLA + sucrose will be given during the circumcision.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EMLA + Sucrose + DPNB</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dorsal penile nerve block (DPNB) will be done with 1% lidocaine without epinephrine injected at two sites at the base of the penis (2 and 10 o'clock). Ten minutes prior to circumcision, the newborn will be placed in the circumcision mold with legs restrained, and attached to a monitor. A total of 2 mg/kg of 1% lidocaine without epinephrine will be used to perform the block, and equal aliquots in milliliters will be injected at the two sites at the base of the penis. The block will be done by the circumciser.&#xD;
In combination with the DPNB, EMLA + sucrose will be given during the circumcision.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sucrose</intervention_name>
    <description>Sucrose was given to three out of the 4 intervention groups, to assess its effectiveness in managing pain during circumcision.</description>
    <arm_group_label>EMLA + Sucrose</arm_group_label>
    <arm_group_label>EMLA + Sucrose + DPNB</arm_group_label>
    <arm_group_label>EMLA + Sucrose + Ring Block</arm_group_label>
    <other_name>25% Sucrose</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <description>Lidocaine was given as a local anesthetic via Ring and Dorsal Penile Block to two of the intervention groups, in combination with the topical cream EMLA and sucking on sucrose.</description>
    <arm_group_label>EMLA + Sucrose + DPNB</arm_group_label>
    <arm_group_label>EMLA + Sucrose + Ring Block</arm_group_label>
    <other_name>Xylocaine and Lignocaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EMLA Topical Product</intervention_name>
    <description>EMLA cream will be applied 70 minutes to the circumcision to all participants of the study.</description>
    <arm_group_label>Control: EMLA Topical Product</arm_group_label>
    <arm_group_label>EMLA + Sucrose</arm_group_label>
    <arm_group_label>EMLA + Sucrose + DPNB</arm_group_label>
    <arm_group_label>EMLA + Sucrose + Ring Block</arm_group_label>
    <other_name>Eutectic Mixture of Local Anesthetics</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy, term, newborn males with a gestational age of 37 weeks or more admitted to&#xD;
             the newborn nursery at the American University of Beirut Medical Center.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unhealthy, premature males.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>3 Days</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>June 28, 2017</last_update_submitted>
  <last_update_submitted_qc>June 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>American University of Beirut Medical Center</investigator_affiliation>
    <investigator_full_name>Rana Sharara</investigator_full_name>
    <investigator_title>Assistant Professor of Pediatrics and Pediatric Critical Care</investigator_title>
  </responsible_party>
  <keyword>Circumcision</keyword>
  <keyword>Analgesia</keyword>
  <keyword>Controlled Clinical Trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Agnosia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Anesthetics, Local</mesh_term>
    <mesh_term>Lidocaine, Prilocaine Drug Combination</mesh_term>
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD will not be shared with researchers outside the scope of the approved list by the Institutional Review Board of the American University of Beirut.&#xD;
Only aggregate and de-identified data will be shared.</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>January 29, 2020</submitted>
    <returned>February 7, 2020</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02990364
org study id: SUR.YE.01
nct id: NCT02990364
lead sponsor: 
has dmc: Yes
Circumcision is a commonly performed procedure on newborn males. Clear recommendations and/or
      guidelines for pain control during the procedure do not exist. The purpose of this research
      is to compare various forms of analgesia to evaluate which is the more effective for pain
      reduction. The investigators hope that this study can provide definitive guidelines on the
      best form of analgesia to use during circumcision. It is important that we perform this study
      to ensure that in the future newborns' pain during circumcision is effectively managed.
Procedure/Interventions/Drugs Several forms of analgesia, including local anesthetic creams
      or local anesthetics administered by injection, will be compared as methods of pain control
      during circumcision. All of these analgesics have already been used for intra-operative pain
      control during circumcision. The drugs that will be used in the study are all local
      anesthetics of the amino-amide group, and include lidocaine and prilocaine. Because there is
      no consensus on the best anesthetic for circumcision, the investigators propose a comparative
      study. Children taking part in this research will be put into groups which are selected by
      chance. There will be three different groups. One of the groups will serve as a control
      group, and in the three other groups combinations of anesthetics will be tested. The control
      group will be receiving the usual anesthetic used in the normal nursery for pain control
      during circumcision, while the combination groups will be receiving additional anesthetic
      agents. Randomization to groups will be done using a random sequence generator. The
      intervention for each patient will then be placed in a sealed envelope, and will be opened by
      the individual performing the circumcision at the time the procedure is scheduled.

      The following interventions will be used:

      EMLA Topical Product:

      EMLA cream is a eutectic mixture of 2.5% lidocaine and 2.5% prilocaine, used as a topical
      anaesthetic to diminish pain from cutaneous procedures. Seventy minutes prior to
      circumcision, the newborn will be placed in the circumcision mold with the legs restrained,
      and attached to a monitor. 1 gram of EMLA cream will be applied by the nurse to the penis
      using a syringe and then wrapped with a dressing (Tegaderm). After sixty minutes they will be
      returned to the circumstrep, reattached to the monitor, and legs will be restrained. The
      Tegaderm and drug will be removed, and the infant will be left to settle then the
      circumcision will take place.

      Dorsal Penile Nerve Block (DPNB):

      Dorsal penile nerve block is an anesthetic technique first described in 1978, and has since
      then been extensively evaluated in the management of pain during circumcision. DPNB will be
      done with 1% lidocaine without epinephrine injected at two sites at the base of the penis (2
      and 10 o'clock). Ten minutes prior to circumcision, the newborn will be placed in the
      circumcision mold with legs restrained, and attached to a monitor. A total of 2 mg/kg of 1%
      lidocaine without epinephrine will be used to perform the block, and equal aliquots in
      milliliters will be injected at the two sites at the base of the penis. The block will be
      done by the circumciser. Five minutes after the block the circumcision will be performed.

      Ring Block:

      Ring block is another anesthetic technique described in the 1990s that has also been examined
      for pain control during circumcision. Ring block will be done with 1% lidocaine without
      epinephrine injected in a band around the penis halfway along the shaft. Ten minutes prior to
      circumcision, the newborn will be placed in the circumcision mold with the legs restrained,
      and attached to a monitor. A total of 2 mg/kg of 1% lidocaine without epinephrine will be
      used to perform the ring block and will be injected in a band around the penis. The block
      will be done by the circumcising physician. Five minutes later the circumcision will be
      performed.

      Intervention groups:

      Control group: (1) EMLA Combination Groups: (2) EMLA + Sucrose (3) EMLA + Ring Block +
      Sucrose; (4) EMLA + Sucrose + DPNB For all groups the same procedures detailed above for
      EMLA, DPNB, and ring block will be followed depending on patient grouping.

      General:

      EMLA will be used on all patients.

      Videotaping:

      In order to ensure that the study is properly blinded, video-taping of the procedure will
      need to take place. A video camera will be set to capture the infant's face and torso and the
      monitor, but not the individual performing the circumcision. The videos will be labeled
      numerically, and not by patient name. Videos will be viewed by two other individuals (not
      present at the circumcision itself and not responsible for obtaining consent), and a possible
      third viewer may be required to resolve conflicting opinions. The video tapes will not be
      seen by any other individual, and will only be for data collection and pain scoring. They
      will be kept in the possession of the two principal investigators in a locked drawer in their
      offices at all times. The video tapes will be destroyed after the completion of the study.

      Outcomes:

      The primary outcome variable will be the pain score. Pain scores consist of behavioral
      components of the infant such as facial expression, crying, breathing patterns, arm movement,
      and leg movement. Secondary outcomes will include effects on heart rate, crying time, and
      oxygen saturation (obtained from the monitor).

      Patients' participation can be ended at any time by the investigator. Significant new
      findings will be conveyed to the parents of the newborn.

      Risks

      The main risks of participation in the study are:

        1. the adverse effects that might result from circumcision itself, such as pain, bleeding,
           surgical trauma, local infections, and meatal stenosis.

        2. adverse effects that may result from drugs, such as allergic reactions

        3. adverse effects that might result from specific drug administration technique, EMLA may
           result in methemoglobinemia and local skin reactions such as blanching, edema, and
           erythema. DPNB and ring block may result in bruising, bleeding, and hematomas at the
           injection site.

        4. adverse effects if the anesthetic is erroneously injected systemically.

      Although the investigators have taken steps to minimize the risks of this study, there may
      also be unforeseeable risks.The parents may choose to withdraw consent at any time during the
      study.

      Benefits All the anesthetics that will be used in the study have already been shown to play a
      role in pain reduction during circumcision, however some seem to be more effective than
      others. The participating child will directly benefit from the study, since his pain will be
      controlled to some extent during the circumcision procedure. Furthermore, if the study
      provides conclusive evidence about the most effective method of analgesia, then guidelines
      can be instituted so that in the future all newborns will have their pain successfully
      controlled during the procedure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: The Neonatal Infant Pain Scale (NIPS)
time frame: During Circumcision, at 1 hour intervals for 4 hours after circumcision and for blinded evaluation
description: The Neonatal Pain Scale (NIPS) is a behavioral assessment tool for measurement of pain in preterm and full-term neonates. This can be used to monitor a neonate before, during and, after a painful procedure such as venipuncture. It was developed at the Children's Hospital of eastern Ontario.
Parameters:
Facial Expression
Cry
Breathing Pattern
Arms
Legs *
State of arousal
The Legs parameter was removed for this study, as the legs are not shown in the video and are tied to the circumcision table during the operation. Moreover, following the circumcision the infants are tucked in via blankets that restrict leg movement.
measure: Heart Rate
time frame: During Circumcision, at 1 hour intervals for 4 hours after circumcision and for blinded evaluation
description: Effects on heart rate, measured by beats/minute
measure: Crying Time
time frame: During Circumcision, at 1 hour intervals for 4 hours after circumcision and for blinded evaluation
description: Crying time, measured in seconds using a stop watch.
measure: Oxygen Saturation
time frame: During Circumcision, at 1 hour intervals for 4 hours after circumcision and for blinded evaluation
description: Oxygen Saturation measured in percent
arm group label: Control: EMLA Topical Product
arm group type: Active Comparator
description: This represents the control group and it is the traditional analgesic used for circumcisions.
EMLA cream is a eutectic mixture of 2.5% lidocaine and 2.5% prilocaine, used as a topical anaesthetic to diminish pain from cutaneous procedures. Seventy minutes prior to circumcision, the newborn will be placed in the circumcision mold with the legs restrained, and attached to a monitor. 1 gram of EMLA cream will be applied by the nurse to the penis using a syringe and then wrapped with a dressing (Tegaderm). After sixty minutes the Tegaderm and drug will be removed, and the infant will be left to settle until the circumcision.
arm group label: EMLA + Sucrose
arm group type: Active Comparator
description: There is high-quality evidence for the beneficial effect of sucrose (24%) with non-nutritive sucking (pacifier dipped in sucrose) or 0.5 mL of sucrose orally in preterm and term infants. To assess this, 10 ml of sucrose (24%) will be given to the infant during the course of the circumcision.
In combination to the EMLA cream, the infant will be given sucrose during the circumcision to test the effects of sucrose and sucking on pain management.
arm group label: EMLA + Sucrose + Ring Block
arm group type: Active Comparator
description: Ring block will be done with 1% lidocaine without epinephrine injected in a band around the penis halfway along the shaft. Ten minutes prior to circumcision, the newborn will be placed in the circumcision mold with the legs restrained, and attached to a monitor. A total of 2 mg/kg of 1% lidocaine without epinephrine will be used to perform the ring block and will be injected in a band around the penis. The block will be done by the circumciser.
In combination with the ring block, EMLA + sucrose will be given during the circumcision.
arm group label: EMLA + Sucrose + DPNB
arm group type: Active Comparator
description: Dorsal penile nerve block (DPNB) will be done with 1% lidocaine without epinephrine injected at two sites at the base of the penis (2 and 10 o'clock). Ten minutes prior to circumcision, the newborn will be placed in the circumcision mold with legs restrained, and attached to a monitor. A total of 2 mg/kg of 1% lidocaine without epinephrine will be used to perform the block, and equal aliquots in milliliters will be injected at the two sites at the base of the penis. The block will be done by the circumciser.
In combination with the DPNB, EMLA + sucrose will be given during the circumcision.
intervention type: Drug
intervention name: Sucrose
description: Sucrose was given to three out of the 4 intervention groups, to assess its effectiveness in managing pain during circumcision.
arm group label: EMLA + Sucrose
arm group label: EMLA + Sucrose + DPNB
arm group label: EMLA + Sucrose + Ring Block
other name: 25% Sucrose
intervention type: Drug
intervention name: Lidocaine
description: Lidocaine was given as a local anesthetic via Ring and Dorsal Penile Block to two of the intervention groups, in combination with the topical cream EMLA and sucking on sucrose.
arm group label: EMLA + Sucrose + DPNB
arm group label: EMLA + Sucrose + Ring Block
other name: Xylocaine and Lignocaine
intervention type: Drug
intervention name: EMLA Topical Product
description: EMLA cream will be applied 70 minutes to the circumcision to all participants of the study.
arm group label: Control: EMLA Topical Product
arm group label: EMLA + Sucrose
arm group label: EMLA + Sucrose + DPNB
arm group label: EMLA + Sucrose + Ring Block
other name: Eutectic Mixture of Local Anesthetics
criteria: 
gender: Male
minimum age: 1 Day
maximum age: 3 Days
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: American University of Beirut Medical Center
investigator full name: Rana Sharara
investigator title: Assistant Professor of Pediatrics and Pediatric Critical Care
mesh term: Agnosia
mesh term: Lidocaine
mesh term: Anesthetics, Local
mesh term: Lidocaine, Prilocaine Drug Combination
mesh term: Anesthetics
sharing ipd: No
ipd description: IPD will not be shared with researchers outside the scope of the approved list by the Institutional Review Board of the American University of Beirut.
Only aggregate and de-identified data will be shared.
submitted: January 29, 2020
returned: February 7, 2020