<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/NCT03786029</url>
  </required_header>
  <id_info>
    <org_study_id>Tishreen - Pre-emptive</org_study_id>
    <nct_id>NCT03786029</nct_id>
  </id_info>
  <brief_title>Pre-emptive Analgesic Administration in Primary Tooth Extraction</brief_title>
  <official_title>Comparison of Pre-emptive Ibuprofen, Acetaminophen, and Placebo Administration in Reducing Local Anesthesia Injection Pain and Post-operative Pain in Primary Tooth Extraction. A Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tishreen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tishreen University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Brief Summary:&#xD;
&#xD;
      Aims: The objective of the current study will be to compare the effectiveness of Ibuprofen,&#xD;
      Acetaminophen, and Placebo on reducing injection pain and post-operative pain in primary&#xD;
      tooth extraction, and to compare the parents' satisfaction.&#xD;
&#xD;
      Design: This will be a blinded, randomized placebo-controlled trial including sixty six&#xD;
      cooperative children, aged 6-8 years old.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background and Aims: The pain could be a problem for the patients during the first few hours&#xD;
      after the extraction because of both soft and hard tissues trauma during the operation,&#xD;
      despite that the local anesthesia will last for a long time in most of the cases.&#xD;
&#xD;
      There are no enough studies that ensure the validity of giving any analgesic in reducing&#xD;
      injection pain and post-operative pain in primary tooth extraction so far.&#xD;
&#xD;
      Design: This will be a blinded, randomized placebo-controlled trial including sixty six&#xD;
      cooperative children, aged 6-8 years old, randomly assigned to one of three groups to receive&#xD;
      one of the oral suspension drugs, that have the same colour and taste, via pre-calibrated&#xD;
      medication bottles, which are identical, numbered and containing the same amount of&#xD;
      pre-calibrated dosages, as per the following portions:&#xD;
&#xD;
        1. Acetaminophen syrup: 160mg/5ml&#xD;
&#xD;
        2. Placebo solution&#xD;
&#xD;
        3. Ibuprofen suspension: 100mg/5ml&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">June 10, 2019</completion_date>
  <primary_completion_date type="Actual">June 1, 2019</primary_completion_date>
  <phase>Phase 2/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>
    <intervention_model_description>Blinded, randomized placebo-controlled trial, comparing three groups.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>The participant will be blinded, the drug administrator will be blinded too, and the investigator who will give the treatment and explain the pain scale to the participant and ask him\her to point to the face that fits the degree of his pain that associated with the drug administration will also be blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment pain related to the injection of the local anesthesia using WBFS.</measure>
    <time_frame>30-60 seconds after injection of the local anesthesia.</time_frame>
    <description>The Wong-Baker Faces Pain Rating Scale (WBFS) is a pain scale that shows a series of faces ranging from a happy face at 0, or &quot;no hurt&quot;, to a crying face at 10, which represents &quot;hurts like the worst pain imaginable&quot;. Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.&#xD;
Immediately after the injection, the child will be asked to point to the face that fits the degree of pain on the self-reporting pain scale, WBFS.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post operative pain assessment using WBFS.</measure>
    <time_frame>10 minutes - 6 hours after the extraction.</time_frame>
    <description>After 10minutes from the injection and immediately after the extraction, the child will be asked to point to the face that fits the degree of pain on the same scale.&#xD;
Re-evaluate the pain after 15minutes from the extraction.&#xD;
The scale will be given to the parents to evaluate the pain post-extraction after an hour to 6 hours while the child is at home.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the parents' satisfaction using Likert fifth scale.</measure>
    <time_frame>6 hours after extraction.</time_frame>
    <description>After the post-operation pain assessment is being done by the parents, the Likert fifth scale is used to determined the degree of parents satisfaction by choosing one of the following degrees: strongly agree, agree, neutral, disagree, strongly disagree.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Local Anesthesia</condition>
  <condition>Tooth Extraction</condition>
  <arm_group>
    <arm_group_label>A (Acetaminophen)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>22 children will receive 320mg (10ml) 30 minutes before the local anesthesia injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B (Placebo)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>22 children will receive 10ml 30 minutes before the local anesthesia injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C (Ibuprofen)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>22 children will receive 200mg (10ml) 30 minutes before the local anesthesia injection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen</intervention_name>
    <description>Patients will receive 320mg (10ml) Acetaminophen (Strawberry flavour), wait for 30 minutes after the administration, then they will be given the local anesthesia injection. Then the child will be asked to point to the face that fits the degree of pain on the self-reporting pain scale WBFS immediately after the injection.&#xD;
The tooth will be extracted 10 minutes after the injection, then the child will be asked to record the degree of pain on the same scale immediately after the extraction.&#xD;
Pain will be re-evaluated 15 minutes after the extraction.&#xD;
The scale will be given to the parents in order to evaluate the post-extraction pain in 1 to 6 hours while the child is at home.&#xD;
Parents' satisfaction will be evaluated using Likert fifth scale.</description>
    <arm_group_label>A (Acetaminophen)</arm_group_label>
    <other_name>A</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Patients will receive 10ml Strawberry Juice (placebo), wait for 30 minutes after the administration, then they will be given the local anesthesia injection. Then the child will be asked to point to the face that fits the degree of pain on the self-reporting pain scale WBFS immediately after the injection.&#xD;
The tooth will be extracted 10 minutes after the injection, then the child will be asked to record the degree of pain on the same scale immediately after the extraction.&#xD;
Pain will be re-evaluated 15 minutes after the extraction.&#xD;
The scale will be given to the parents in order to evaluate the post-extraction pain in 1 to 6 hours while the child is at home.&#xD;
Parents' satisfaction will be evaluated using Likert fifth scale.</description>
    <arm_group_label>B (Placebo)</arm_group_label>
    <other_name>B</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibuprofen</intervention_name>
    <description>Patients will receive 200mg (10ml) of Ibuprofen (Strawberry flavour), wait for 30 minutes after the administration, then they will be given the local anesthesia injection. Then the child will be asked to point to the face that fits the degree of pain on the self-reporting pain scale WBFS immediately after the injection.&#xD;
The tooth will be extracted 10 minutes after the injection, then the child will be asked to record the degree of pain on the same scale immediately after the extraction.&#xD;
Pain will be re-evaluated 15 minutes after the extraction.&#xD;
The scale will be given to the parents in order to evaluate the post-extraction pain in 1 to 6 hours while the child is at home.&#xD;
Parents' satisfaction will be evaluated using Likert fifth scale.</description>
    <arm_group_label>C (Ibuprofen)</arm_group_label>
    <other_name>C</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Teeth with an abscess or infection exceeding one-third of the interradicular area (not&#xD;
        exceeding the oral cavity) 2. Unrestorable decayed teeth. 3. Teeth with periapical /&#xD;
        interradicular lesions.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Teeth with advanced root resorption (a third of the root at least)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nabih Raslan, Dr</last_name>
    <role>Study Chair</role>
    <affiliation>Tishreen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tishreen University</name>
      <address>
        <city>Latakia</city>
        <country>Syrian Arab Republic</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Syrian Arab Republic</country>
  </location_countries>
  <reference>
    <citation>Ashley PF, Parekh S, Moles DR, Anand P, MacDonald LC. Preoperative analgesics for additional pain relief in children and adolescents having dental treatment. Cochrane Database Syst Rev. 2016 Aug 8;2016(8):CD008392. doi: 10.1002/14651858.CD008392.pub3.</citation>
    <PMID>27501304</PMID>
  </reference>
  <reference>
    <citation>Pozos-Guillen A, Martinez-Rider R, Aguirre-Banuelos P, Perez-Urizar J. Pre-emptive analgesic effect of tramadol after mandibular third molar extraction: a pilot study. J Oral Maxillofac Surg. 2007 Jul;65(7):1315-20. doi: 10.1016/j.joms.2006.10.079.</citation>
    <PMID>17577495</PMID>
  </reference>
  <reference>
    <citation>Gazal G, Mackie IC. A comparison of paracetamol, ibuprofen or their combination for pain relief following extractions in children under general anaesthesia: a randomized controlled trial. Int J Paediatr Dent. 2007 May;17(3):169-77. doi: 10.1111/j.1365-263X.2006.00806.x.</citation>
    <PMID>17397460</PMID>
  </reference>
  <reference>
    <citation>Baygin O, Tuzuner T, Isik B, Kusgoz A, Tanriver M. Comparison of pre-emptive ibuprofen, paracetamol, and placebo administration in reducing post-operative pain in primary tooth extraction. Int J Paediatr Dent. 2011 Jul;21(4):306-13. doi: 10.1111/j.1365-263X.2011.01124.x. Epub 2011 Apr 6.</citation>
    <PMID>21470320</PMID>
  </reference>
  <reference>
    <citation>Ashkenazi M, Blumer S, Eli I. Post-operative pain and use of analgesic agents in children following intrasulcular anaesthesia and various operative procedures. Br Dent J. 2007 Mar 10;202(5):E13; discussion 276-7. doi: 10.1038/bdj.2007.81. Epub 2007 Feb 2.</citation>
    <PMID>17273178</PMID>
  </reference>
  <reference>
    <citation>Jurgens S, Warwick RS, Inglehearn PJ, Gooneratne DS. Pain relief for paediatric dental chair anaesthesia: current practice in a community dental clinic. Int J Paediatr Dent. 2003 Mar;13(2):93-7. doi: 10.1046/j.1365-263x.2003.00430.x.</citation>
    <PMID>12605626</PMID>
  </reference>
  <reference>
    <citation>Primosch RE, Nichols DL, Courts FJ. Comparison of preoperative ibuprofen, acetaminophen, and placebo administration on the parental report of postextraction pain in children. Pediatr Dent. 1995 May-Jun;17(3):187-91.</citation>
    <PMID>7617493</PMID>
  </reference>
  <reference>
    <citation>McGaw T, Raborn W, Grace M. Analgesics in pediatric dental surgery: relative efficacy of aluminum ibuprofen suspension and acetaminophen elixir. ASDC J Dent Child. 1987 Mar-Apr;54(2):106-9.</citation>
    <PMID>3470325</PMID>
  </reference>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>December 15, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>June 14, 2019</last_update_submitted>
  <last_update_submitted_qc>June 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tishreen University</investigator_affiliation>
    <investigator_full_name>Nabih Raslan</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Pre-emptive administration</keyword>
  <keyword>Analgesic</keyword>
  <keyword>Tooth extraction</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Ibuprofen</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Up to date, there is no decision about IPD sharing.</ipd_description>
  </patient_data>
  <!-- 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/NCT03786029
org study id: Tishreen - Pre-emptive
nct id: NCT03786029
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Brief Summary:

      Aims: The objective of the current study will be to compare the effectiveness of Ibuprofen,
      Acetaminophen, and Placebo on reducing injection pain and post-operative pain in primary
      tooth extraction, and to compare the parents' satisfaction.

      Design: This will be a blinded, randomized placebo-controlled trial including sixty six
      cooperative children, aged 6-8 years old.
Background and Aims: The pain could be a problem for the patients during the first few hours
      after the extraction because of both soft and hard tissues trauma during the operation,
      despite that the local anesthesia will last for a long time in most of the cases.

      There are no enough studies that ensure the validity of giving any analgesic in reducing
      injection pain and post-operative pain in primary tooth extraction so far.

      Design: This will be a blinded, randomized placebo-controlled trial including sixty six
      cooperative children, aged 6-8 years old, randomly assigned to one of three groups to receive
      one of the oral suspension drugs, that have the same colour and taste, via pre-calibrated
      medication bottles, which are identical, numbered and containing the same amount of
      pre-calibrated dosages, as per the following portions:

        1. Acetaminophen syrup: 160mg/5ml

        2. Placebo solution

        3. Ibuprofen suspension: 100mg/5ml
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Blinded, randomized placebo-controlled trial, comparing three groups.
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: The participant will be blinded, the drug administrator will be blinded too, and the investigator who will give the treatment and explain the pain scale to the participant and ask him\her to point to the face that fits the degree of his pain that associated with the drug administration will also be blinded.
measure: Assessment pain related to the injection of the local anesthesia using WBFS.
time frame: 30-60 seconds after injection of the local anesthesia.
description: The Wong-Baker Faces Pain Rating Scale (WBFS) is a pain scale that shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.
Immediately after the injection, the child will be asked to point to the face that fits the degree of pain on the self-reporting pain scale, WBFS.
measure: Post operative pain assessment using WBFS.
time frame: 10 minutes - 6 hours after the extraction.
description: After 10minutes from the injection and immediately after the extraction, the child will be asked to point to the face that fits the degree of pain on the same scale.
Re-evaluate the pain after 15minutes from the extraction.
The scale will be given to the parents to evaluate the pain post-extraction after an hour to 6 hours while the child is at home.
measure: Evaluate the parents' satisfaction using Likert fifth scale.
time frame: 6 hours after extraction.
description: After the post-operation pain assessment is being done by the parents, the Likert fifth scale is used to determined the degree of parents satisfaction by choosing one of the following degrees: strongly agree, agree, neutral, disagree, strongly disagree.
arm group label: A (Acetaminophen)
arm group type: Experimental
description: 22 children will receive 320mg (10ml) 30 minutes before the local anesthesia injection.
arm group label: B (Placebo)
arm group type: Placebo Comparator
description: 22 children will receive 10ml 30 minutes before the local anesthesia injection.
arm group label: C (Ibuprofen)
arm group type: Experimental
description: 22 children will receive 200mg (10ml) 30 minutes before the local anesthesia injection.
intervention type: Drug
intervention name: Acetaminophen
description: Patients will receive 320mg (10ml) Acetaminophen (Strawberry flavour), wait for 30 minutes after the administration, then they will be given the local anesthesia injection. Then the child will be asked to point to the face that fits the degree of pain on the self-reporting pain scale WBFS immediately after the injection.
The tooth will be extracted 10 minutes after the injection, then the child will be asked to record the degree of pain on the same scale immediately after the extraction.
Pain will be re-evaluated 15 minutes after the extraction.
The scale will be given to the parents in order to evaluate the post-extraction pain in 1 to 6 hours while the child is at home.
Parents' satisfaction will be evaluated using Likert fifth scale.
arm group label: A (Acetaminophen)
other name: A
intervention type: Drug
intervention name: Placebo
description: Patients will receive 10ml Strawberry Juice (placebo), wait for 30 minutes after the administration, then they will be given the local anesthesia injection. Then the child will be asked to point to the face that fits the degree of pain on the self-reporting pain scale WBFS immediately after the injection.
The tooth will be extracted 10 minutes after the injection, then the child will be asked to record the degree of pain on the same scale immediately after the extraction.
Pain will be re-evaluated 15 minutes after the extraction.
The scale will be given to the parents in order to evaluate the post-extraction pain in 1 to 6 hours while the child is at home.
Parents' satisfaction will be evaluated using Likert fifth scale.
arm group label: B (Placebo)
other name: B
intervention type: Drug
intervention name: Ibuprofen
description: Patients will receive 200mg (10ml) of Ibuprofen (Strawberry flavour), wait for 30 minutes after the administration, then they will be given the local anesthesia injection. Then the child will be asked to point to the face that fits the degree of pain on the self-reporting pain scale WBFS immediately after the injection.
The tooth will be extracted 10 minutes after the injection, then the child will be asked to record the degree of pain on the same scale immediately after the extraction.
Pain will be re-evaluated 15 minutes after the extraction.
The scale will be given to the parents in order to evaluate the post-extraction pain in 1 to 6 hours while the child is at home.
Parents' satisfaction will be evaluated using Likert fifth scale.
arm group label: C (Ibuprofen)
other name: C
criteria: 
gender: All
minimum age: 6 Years
maximum age: 8 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nabih Raslan, Dr
role: Study Chair
affiliation: Tishreen University
facility: 
country: Syrian Arab Republic
citation: Ashley PF, Parekh S, Moles DR, Anand P, MacDonald LC. Preoperative analgesics for additional pain relief in children and adolescents having dental treatment. Cochrane Database Syst Rev. 2016 Aug 8;2016(8):CD008392. doi: 10.1002/14651858.CD008392.pub3.
PMID: 27501304
citation: Pozos-Guillen A, Martinez-Rider R, Aguirre-Banuelos P, Perez-Urizar J. Pre-emptive analgesic effect of tramadol after mandibular third molar extraction: a pilot study. J Oral Maxillofac Surg. 2007 Jul;65(7):1315-20. doi: 10.1016/j.joms.2006.10.079.
PMID: 17577495
citation: Gazal G, Mackie IC. A comparison of paracetamol, ibuprofen or their combination for pain relief following extractions in children under general anaesthesia: a randomized controlled trial. Int J Paediatr Dent. 2007 May;17(3):169-77. doi: 10.1111/j.1365-263X.2006.00806.x.
PMID: 17397460
citation: Baygin O, Tuzuner T, Isik B, Kusgoz A, Tanriver M. Comparison of pre-emptive ibuprofen, paracetamol, and placebo administration in reducing post-operative pain in primary tooth extraction. Int J Paediatr Dent. 2011 Jul;21(4):306-13. doi: 10.1111/j.1365-263X.2011.01124.x. Epub 2011 Apr 6.
PMID: 21470320
citation: Ashkenazi M, Blumer S, Eli I. Post-operative pain and use of analgesic agents in children following intrasulcular anaesthesia and various operative procedures. Br Dent J. 2007 Mar 10;202(5):E13; discussion 276-7. doi: 10.1038/bdj.2007.81. Epub 2007 Feb 2.
PMID: 17273178
citation: Jurgens S, Warwick RS, Inglehearn PJ, Gooneratne DS. Pain relief for paediatric dental chair anaesthesia: current practice in a community dental clinic. Int J Paediatr Dent. 2003 Mar;13(2):93-7. doi: 10.1046/j.1365-263x.2003.00430.x.
PMID: 12605626
citation: Primosch RE, Nichols DL, Courts FJ. Comparison of preoperative ibuprofen, acetaminophen, and placebo administration on the parental report of postextraction pain in children. Pediatr Dent. 1995 May-Jun;17(3):187-91.
PMID: 7617493
citation: McGaw T, Raborn W, Grace M. Analgesics in pediatric dental surgery: relative efficacy of aluminum ibuprofen suspension and acetaminophen elixir. ASDC J Dent Child. 1987 Mar-Apr;54(2):106-9.
PMID: 3470325
responsible party type: Principal Investigator
investigator affiliation: Tishreen University
investigator full name: Nabih Raslan
investigator title: Principal Investigator
mesh term: Acetaminophen
mesh term: Ibuprofen
sharing ipd: Undecided
ipd description: Up to date, there is no decision about IPD sharing.