<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/NCT02223377</url>
  </required_header>
  <id_info>
    <org_study_id>14-482</org_study_id>
    <secondary_id>CAS-2014-038</secondary_id>
    <nct_id>NCT02223377</nct_id>
  </id_info>
  <brief_title>Satisfactory Analgesia Minimal Emesis in Day Surgeries</brief_title>
  <acronym>SAME-Day</acronym>
  <official_title>Most Effective Opioid Analgesia in Ambulatory Surgeries: a Randomized Control, Investigator Blinded, Parallel Group With Superiority Design Study of Morphine Versus Hydromorphone</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McMaster University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Currently nearly 70% or more surgeries are being done as ambulatory (day care) procedures as&#xD;
      they offer significant benefit to the patients as well as to the hospitals. Inadequate pain&#xD;
      relief (30%-40%) and nausea-vomiting form the leading factors affecting the quality of care&#xD;
      and hence its efficiency. Opioids form the primary modality to treat moderate to severe pain,&#xD;
      but can also cause significant nausea-vomiting and other side effects. Although hydromorphone&#xD;
      is five times more potent than morphine, in equianalgesic doses they both could provide&#xD;
      similar pain relief. They both exert no ceiling effect for their analgesia, and hence&#xD;
      incomplete or inadequate analgesia is related to the appearance of side effects. In this&#xD;
      study the investigators shall assess the proportion of patients who satisfy the outcome of&#xD;
      'satisfactory analgesia with minimal nausea-vomiting' in ambulatory surgeries, assessed at 2&#xD;
      hours after surgery. Patients would be randomized to receive either morphine or hydromorphone&#xD;
      in the surgical recovery area. All personnel involved with the study would be blinded. The&#xD;
      investigators will also look to assess the time to discharge and other side effects. This&#xD;
      will help to choose the better drug, thereby improving pain relief and side effects, and also&#xD;
      the efficiency of health care delivery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There has been an exponential increase in the number of day case surgical procedures also&#xD;
      called as ambulatory surgeries (AS), over the last 2 years.(1) Currently around 70% of&#xD;
      procedures are being done as AS, with known benefits to patients and hospitals.(2) Its&#xD;
      efficiency and cost effectiveness depends upon its organization and delivery of services.&#xD;
      Pain and PONV are recognized as the leading factors affecting the quality of services&#xD;
      delivered under AS,(1,3) and they affect the recovery, discharge, and overall satisfaction of&#xD;
      patients.(4,5) According to literature, postsurgical pain could be inadequately treated in&#xD;
      30%-60% of patients and 30%-40% of AS patients suffer from significant PONV.(3,6,7) It is&#xD;
      estimated that a single episode of PONV can prolong the PACU stay by 25 mins,(8) and patients&#xD;
      rate PONV to be the most undesirable outcome associated with anesthesia.(4) Despite the&#xD;
      increasing use of non-opioid analgesics, opioid analgesics have remained the primary modality&#xD;
      in moderate to severe pain.(7) They cause several side effects such as drowsiness, sedation,&#xD;
      PONV, itching and respiratory depression. Appropriate selection of opioid medications becomes&#xD;
      significantly important to deliver safe and effective analgesia with minimal side effects.&#xD;
      Although M has been the most commonly used medication, HM is also being increasingly used.(9)&#xD;
      We do not yet know whether HM is more effective than M in AS patients. Both M and HM exert no&#xD;
      ceiling effect for their analgesia, and by this nature incomplete or inadequate analgesia is&#xD;
      related to the appearance of side effects.(10) Hence clinical effectiveness of opioids,&#xD;
      relative to each other, is reflected not just by satisfactory analgesia, but by a combination&#xD;
      of 'satisfactory analgesia with limited side effects'. Clinical observation suggests that HM&#xD;
      is clinically better by providing superior or equivalent analgesia with decreased side&#xD;
      effects.(9) HM is a semi-synthetic morphine derivative that differs from M in its position 6&#xD;
      of the benzol ring, where it has a keto-group instead of a hydroxy group, making it 5-10&#xD;
      times more potent and enhances its distribution to cerebral tissues, making for easier&#xD;
      titration.(9) The t1/2 Ke0 (transfer life from plasma to effect site) is 1.6hr - 4 hr for M,&#xD;
      compared to 18-38 min for HM.(9,10) It is observed that health care providers may be willing&#xD;
      to provide higher dose of HM compared to M in EMU, as its actual quantity of drug is much&#xD;
      smaller and therefore appears to cause less concern.(12, 13) Our literature review showed&#xD;
      that there are no previous studies comparing these 2 medications in AS patients. The lone&#xD;
      systematic review compared various acute and chronic pain studies, in various routes of drug&#xD;
      administration.(9) Of the 11 studies identified; only 4 were done in acute pain&#xD;
      settings.(13-16) Two of them were done by the same author in ER settings. Chang et al noted&#xD;
      that HM reduced the mean pain scores by 1.3 units [95% CI= (-2.2 to -0.5)] compared to M in&#xD;
      198 adults treated in ER.(12,13). However it did not show much difference in geriatric&#xD;
      population.14 In perioperative settings, Hong et al studied the difference in nausea between&#xD;
      the 2 medications in 50 patients using PCA and found no difference.(15) Rapp et al studied&#xD;
      various effects between the 2 medications in 61 surgical patients using PCA. There is not&#xD;
      much clarity about their primary outcome; however they found the effects to be similar.(16)&#xD;
      Both these studies had smaller sample sizes. The meta-analysis performed demonstrated that&#xD;
      the HM does provide better analgesia than M, with a small effect size; Cohen's d=0.266&#xD;
      (p=0.012).(9) Looked at acute pain alone it was statistically significant (p=0.006), compared&#xD;
      to chronic pain (p=0.889). It was noted that that there is a definite lack of comparative&#xD;
      studies between them in surgical settings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">March 2019</completion_date>
  <primary_completion_date type="Actual">March 2019</primary_completion_date>
  <phase>N/A</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Our combined primary outcome will be proportion of patients with Same Analgesia Minimal Emesis, as compared between the 2 groups.</measure>
    <time_frame>At 2hrs or at the time of discharge from PACU</time_frame>
    <description>Our combined primary outcome will be proportion of patients with SAME, as compared between the 2 groups. Analgesia will be based on Numerical Analogue Scale for Pain 0-10 (appendix 3), and Post-operative nausea and vomiting will be based on Verbal Descriptive Scale 0-5 (appendix 3). These observations will be made at the end of 2 hrs or before (corresponding to the time of discharge from PACU), by the PACU nurse.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severe itching</measure>
    <time_frame>At 2hrs or at the time of discharge from PACU</time_frame>
    <description>Visual Analog Scale 0-10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe sedation</measure>
    <time_frame>At 2hrs or at the time of discharge from PACU</time_frame>
    <description>Ramsay Sedation Scale 0-6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe Respiratory Depression</measure>
    <time_frame>At 2hrs or at the time of discharge from PACU</time_frame>
    <description>Presence of Respiratory Rate below 10 and/or Presence of Oxygen Saturation &lt;90</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Ketorolac</measure>
    <time_frame>At 2hrs or at the time of discharge from PACU</time_frame>
    <description>Use of rescue drug for pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean dose of analgesic used</measure>
    <time_frame>5 hours post-admit to hospital</time_frame>
    <description>For a day surgery case, from the time of hospital admittance to discharge from hospital is an average 5 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction Score</measure>
    <time_frame>At 5 hours post-admit to hospital</time_frame>
    <description>For a day surgery case, from the time of hospital admittance to discharge from hospital is an average 5 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to discharge from PACU</measure>
    <time_frame>At 2hrs or at the time of discharge from PACU</time_frame>
    <description>For a day surgery case, from the time out of operating room to discharge from PACU is an average 2 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to discharge from hospital</measure>
    <time_frame>At 5 hours post-admit to hospital</time_frame>
    <description>For a day surgery case, from the time of hospital admittance to discharge from hospital is an average 5 hours.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">402</enrollment>
  <condition>Pain</condition>
  <condition>Post Operative Nausea and Vomiting</condition>
  <arm_group>
    <arm_group_label>Morphine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).&#xD;
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hydromorphone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).&#xD;
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Morphine</intervention_name>
    <description>Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)</description>
    <arm_group_label>Morphine</arm_group_label>
    <other_name>Sandoz</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydromorphone</intervention_name>
    <description>Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)</description>
    <arm_group_label>Hydromorphone</arm_group_label>
    <other_name>Sandoz</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ambulatory surgeries producing at least moderate pain-such as cholecystectomy,&#xD;
             appendicectomy, ovarian cystectomy, inguinal hernia repair, abdominal wall hernias&#xD;
&#xD;
          -  ability to communicate in English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergy to M or HM&#xD;
&#xD;
          -  patient on regular chronic opioid medication&#xD;
&#xD;
          -  patient uncontrolled systemic disease&#xD;
&#xD;
          -  severe obesity with a BMI &gt;35&#xD;
&#xD;
          -  significant psychological impairment&#xD;
&#xD;
          -  history of drug addiction or dependence&#xD;
&#xD;
          -  any planned regional or nerve block other than local anesthesia infiltration patients&#xD;
             with confirmed sleep apnea&#xD;
&#xD;
          -  emergency surgeries and urological surgeries&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harsha Shanthanna, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Joseph's Healthcare Hamilton/McMaster University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>James Paul, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hamilton Health Sciences/McMaster University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hamilton Health Sciences</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8L 2X2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph's Healthcare Hamilton</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N 4A6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Sarin P, Philip BK, Mitani A, Eappen S, Urman RD. Specialized ambulatory anesthesia teams contribute to decreased ambulatory surgery recovery room length of stay. Ochsner J. 2012 Summer;12(2):94-100.</citation>
    <PMID>22778673</PMID>
  </reference>
  <reference>
    <citation>Troy AM, Cunningham AJ. Ambulatory surgery: an overview. Curr Opin Anaesthesiol. 2002 Dec;15(6):647-57. doi: 10.1097/00001503-200212000-00008.</citation>
    <PMID>17019266</PMID>
  </reference>
  <reference>
    <citation>Shnaider I, Chung F. Outcomes in day surgery. Curr Opin Anaesthesiol. 2006 Dec;19(6):622-9. doi: 10.1097/ACO.0b013e328010107e.</citation>
    <PMID>17093366</PMID>
  </reference>
  <reference>
    <citation>Macario A, Weinger M, Carney S, Kim A. Which clinical anesthesia outcomes are important to avoid? The perspective of patients. Anesth Analg. 1999 Sep;89(3):652-8. doi: 10.1097/00000539-199909000-00022.</citation>
    <PMID>10475299</PMID>
  </reference>
  <reference>
    <citation>Chatterjee S, Rudra A, Sengupta S. Current concepts in the management of postoperative nausea and vomiting. Anesthesiol Res Pract. 2011;2011:748031. doi: 10.1155/2011/748031. Epub 2011 Nov 3.</citation>
    <PMID>22110499</PMID>
  </reference>
  <reference>
    <citation>White PF. Pain management after ambulatory surgery - where is the disconnect? Can J Anaesth. 2008 Apr;55(4):201-7. doi: 10.1007/BF03021503. No abstract available. English, French.</citation>
    <PMID>18378964</PMID>
  </reference>
  <reference>
    <citation>Felden L, Walter C, Harder S, Treede RD, Kayser H, Drover D, Geisslinger G, Lotsch J. Comparative clinical effects of hydromorphone and morphine: a meta-analysis. Br J Anaesth. 2011 Sep;107(3):319-28. doi: 10.1093/bja/aer232. Epub 2011 Aug 5.</citation>
    <PMID>21841049</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>January 10, 2020</last_update_submitted>
  <last_update_submitted_qc>January 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vomiting</mesh_term>
    <mesh_term>Postoperative Nausea and Vomiting</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Morphine</mesh_term>
    <mesh_term>Hydromorphone</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>April 14, 2020</submitted>
    <returned>April 28, 2020</returned>
    <submitted>October 5, 2021</submitted>
    <returned>November 1, 2021</returned>
    <submitted>March 14, 2023</submitted>
  </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/NCT02223377
org study id: 14-482
secondary id: CAS-2014-038
nct id: NCT02223377
lead sponsor: 
has dmc: No
Currently nearly 70% or more surgeries are being done as ambulatory (day care) procedures as
      they offer significant benefit to the patients as well as to the hospitals. Inadequate pain
      relief (30%-40%) and nausea-vomiting form the leading factors affecting the quality of care
      and hence its efficiency. Opioids form the primary modality to treat moderate to severe pain,
      but can also cause significant nausea-vomiting and other side effects. Although hydromorphone
      is five times more potent than morphine, in equianalgesic doses they both could provide
      similar pain relief. They both exert no ceiling effect for their analgesia, and hence
      incomplete or inadequate analgesia is related to the appearance of side effects. In this
      study the investigators shall assess the proportion of patients who satisfy the outcome of
      'satisfactory analgesia with minimal nausea-vomiting' in ambulatory surgeries, assessed at 2
      hours after surgery. Patients would be randomized to receive either morphine or hydromorphone
      in the surgical recovery area. All personnel involved with the study would be blinded. The
      investigators will also look to assess the time to discharge and other side effects. This
      will help to choose the better drug, thereby improving pain relief and side effects, and also
      the efficiency of health care delivery.
There has been an exponential increase in the number of day case surgical procedures also
      called as ambulatory surgeries (AS), over the last 2 years.(1) Currently around 70% of
      procedures are being done as AS, with known benefits to patients and hospitals.(2) Its
      efficiency and cost effectiveness depends upon its organization and delivery of services.
      Pain and PONV are recognized as the leading factors affecting the quality of services
      delivered under AS,(1,3) and they affect the recovery, discharge, and overall satisfaction of
      patients.(4,5) According to literature, postsurgical pain could be inadequately treated in
      30%-60% of patients and 30%-40% of AS patients suffer from significant PONV.(3,6,7) It is
      estimated that a single episode of PONV can prolong the PACU stay by 25 mins,(8) and patients
      rate PONV to be the most undesirable outcome associated with anesthesia.(4) Despite the
      increasing use of non-opioid analgesics, opioid analgesics have remained the primary modality
      in moderate to severe pain.(7) They cause several side effects such as drowsiness, sedation,
      PONV, itching and respiratory depression. Appropriate selection of opioid medications becomes
      significantly important to deliver safe and effective analgesia with minimal side effects.
      Although M has been the most commonly used medication, HM is also being increasingly used.(9)
      We do not yet know whether HM is more effective than M in AS patients. Both M and HM exert no
      ceiling effect for their analgesia, and by this nature incomplete or inadequate analgesia is
      related to the appearance of side effects.(10) Hence clinical effectiveness of opioids,
      relative to each other, is reflected not just by satisfactory analgesia, but by a combination
      of 'satisfactory analgesia with limited side effects'. Clinical observation suggests that HM
      is clinically better by providing superior or equivalent analgesia with decreased side
      effects.(9) HM is a semi-synthetic morphine derivative that differs from M in its position 6
      of the benzol ring, where it has a keto-group instead of a hydroxy group, making it 5-10
      times more potent and enhances its distribution to cerebral tissues, making for easier
      titration.(9) The t1/2 Ke0 (transfer life from plasma to effect site) is 1.6hr - 4 hr for M,
      compared to 18-38 min for HM.(9,10) It is observed that health care providers may be willing
      to provide higher dose of HM compared to M in EMU, as its actual quantity of drug is much
      smaller and therefore appears to cause less concern.(12, 13) Our literature review showed
      that there are no previous studies comparing these 2 medications in AS patients. The lone
      systematic review compared various acute and chronic pain studies, in various routes of drug
      administration.(9) Of the 11 studies identified; only 4 were done in acute pain
      settings.(13-16) Two of them were done by the same author in ER settings. Chang et al noted
      that HM reduced the mean pain scores by 1.3 units [95% CI= (-2.2 to -0.5)] compared to M in
      198 adults treated in ER.(12,13). However it did not show much difference in geriatric
      population.14 In perioperative settings, Hong et al studied the difference in nausea between
      the 2 medications in 50 patients using PCA and found no difference.(15) Rapp et al studied
      various effects between the 2 medications in 61 surgical patients using PCA. There is not
      much clarity about their primary outcome; however they found the effects to be similar.(16)
      Both these studies had smaller sample sizes. The meta-analysis performed demonstrated that
      the HM does provide better analgesia than M, with a small effect size; Cohen's d=0.266
      (p=0.012).(9) Looked at acute pain alone it was statistically significant (p=0.006), compared
      to chronic pain (p=0.889). It was noted that that there is a definite lack of comparative
      studies between them in surgical settings.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Our combined primary outcome will be proportion of patients with Same Analgesia Minimal Emesis, as compared between the 2 groups.
time frame: At 2hrs or at the time of discharge from PACU
description: Our combined primary outcome will be proportion of patients with SAME, as compared between the 2 groups. Analgesia will be based on Numerical Analogue Scale for Pain 0-10 (appendix 3), and Post-operative nausea and vomiting will be based on Verbal Descriptive Scale 0-5 (appendix 3). These observations will be made at the end of 2 hrs or before (corresponding to the time of discharge from PACU), by the PACU nurse.
measure: Severe itching
time frame: At 2hrs or at the time of discharge from PACU
description: Visual Analog Scale 0-10
measure: Severe sedation
time frame: At 2hrs or at the time of discharge from PACU
description: Ramsay Sedation Scale 0-6
measure: Severe Respiratory Depression
time frame: At 2hrs or at the time of discharge from PACU
description: Presence of Respiratory Rate below 10 and/or Presence of Oxygen Saturation <90
measure: Use of Ketorolac
time frame: At 2hrs or at the time of discharge from PACU
description: Use of rescue drug for pain
measure: Mean dose of analgesic used
time frame: 5 hours post-admit to hospital
description: For a day surgery case, from the time of hospital admittance to discharge from hospital is an average 5 hours.
measure: Patient Satisfaction Score
time frame: At 5 hours post-admit to hospital
description: For a day surgery case, from the time of hospital admittance to discharge from hospital is an average 5 hours.
measure: Time to discharge from PACU
time frame: At 2hrs or at the time of discharge from PACU
description: For a day surgery case, from the time out of operating room to discharge from PACU is an average 2 hours.
measure: Time to discharge from hospital
time frame: At 5 hours post-admit to hospital
description: For a day surgery case, from the time of hospital admittance to discharge from hospital is an average 5 hours.
arm group label: Morphine
arm group type: Active Comparator
description: Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)
arm group label: Hydromorphone
arm group type: Active Comparator
description: Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)
intervention type: Drug
intervention name: Morphine
description: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
arm group label: Morphine
other name: Sandoz
intervention type: Drug
intervention name: Hydromorphone
description: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
arm group label: Hydromorphone
other name: Sandoz
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Harsha Shanthanna, MD
role: Principal Investigator
affiliation: St. Joseph's Healthcare Hamilton/McMaster University
last name: James Paul, MD
role: Principal Investigator
affiliation: Hamilton Health Sciences/McMaster University
facility: 
facility: 
country: Canada
citation: Sarin P, Philip BK, Mitani A, Eappen S, Urman RD. Specialized ambulatory anesthesia teams contribute to decreased ambulatory surgery recovery room length of stay. Ochsner J. 2012 Summer;12(2):94-100.
PMID: 22778673
citation: Troy AM, Cunningham AJ. Ambulatory surgery: an overview. Curr Opin Anaesthesiol. 2002 Dec;15(6):647-57. doi: 10.1097/00001503-200212000-00008.
PMID: 17019266
citation: Shnaider I, Chung F. Outcomes in day surgery. Curr Opin Anaesthesiol. 2006 Dec;19(6):622-9. doi: 10.1097/ACO.0b013e328010107e.
PMID: 17093366
citation: Macario A, Weinger M, Carney S, Kim A. Which clinical anesthesia outcomes are important to avoid? The perspective of patients. Anesth Analg. 1999 Sep;89(3):652-8. doi: 10.1097/00000539-199909000-00022.
PMID: 10475299
citation: Chatterjee S, Rudra A, Sengupta S. Current concepts in the management of postoperative nausea and vomiting. Anesthesiol Res Pract. 2011;2011:748031. doi: 10.1155/2011/748031. Epub 2011 Nov 3.
PMID: 22110499
citation: White PF. Pain management after ambulatory surgery - where is the disconnect? Can J Anaesth. 2008 Apr;55(4):201-7. doi: 10.1007/BF03021503. No abstract available. English, French.
PMID: 18378964
citation: Felden L, Walter C, Harder S, Treede RD, Kayser H, Drover D, Geisslinger G, Lotsch J. Comparative clinical effects of hydromorphone and morphine: a meta-analysis. Br J Anaesth. 2011 Sep;107(3):319-28. doi: 10.1093/bja/aer232. Epub 2011 Aug 5.
PMID: 21841049
responsible party type: Sponsor
mesh term: Vomiting
mesh term: Postoperative Nausea and Vomiting
mesh term: Morphine
mesh term: Hydromorphone
submitted: April 14, 2020
returned: April 28, 2020
submitted: October 5, 2021
returned: November 1, 2021
submitted: March 14, 2023