PainSAME-DayNCT02223377
Satisfactory Analgesia Minimal Emesis in Day Surgeries
A study testing Morphine and Hydromorphone in people with Pain and Post Operative Nausea and Vomiting, run by McMaster University at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain, Post Operative Nausea and Vomiting
- What is being tested?
- Morphine and Hydromorphone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2015to Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ambulatory surgeries producing at least moderate pain-such as cholecystectomy, appendicectomy, ovarian cystectomy, inguinal hernia repair, abdominal wall hernias
- ability to communicate in English.
Who cannot join
- allergy to M or HM
- patient on regular chronic opioid medication
- patient uncontrolled systemic disease
- severe obesity with a BMI >35
- significant psychological impairment
- history of drug addiction or dependence
- any planned regional or nerve block other than local anesthesia infiltration patients with confirmed sleep apnea
- emergency surgeries and urological surgeries
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
About this study
Official title: Most Effective Opioid Analgesia in Ambulatory Surgeries: a Randomized Control, Investigator Blinded, Parallel Group With Superiority Design Study of Morphine Versus Hydromorphone
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.
Read the detailed description
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.
- Conditions
- Pain, Post Operative Nausea and Vomiting
- Being tested
- Morphine, Hydromorphone
- Medical subject headings
- Pain, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Also called Sandoz
1st dose: syringe of 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 is administered. 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)
HydromorphoneDrug
Also called Sandoz
1st dose: syringe of 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 is administered. 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)
| Study group | Role | What they receive |
|---|---|---|
| Morphine | Active comparator | 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) Receives: Drug: Morphine |
| Hydromorphone | Active comparator | 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) Receives: Drug: Hydromorphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Our Combined Primary Outcome Will be Number of Patients With Same Analgesia Minimal Emesis, as Compared Between the 2 Groups.
Our combined primary outcome will be number 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.
Measured: At 2hrs or at the time of discharge from PACU
Secondary outcomes (8)
Number of Patients With Severe Itching
Severe itching measured as visual analog scale score > 5 on a 0-10 Visual Analog Scale, where 0 = no itching, and 10 = worst itching imaginable
Measured: At 2hrs or at the time of discharge from PACU
Severe Sedation
Ramsay Sedation Scale 0-6
Measured: At 2hrs or at the time of discharge from PACU
Severe Respiratory Depression
Presence of Respiratory Rate below 10 and/or Presence of Oxygen Saturation <90
Measured: At 2hrs or at the time of discharge from PACU
Patients Requesting Oral Analgesia in the Day Surgery Unit
Use of rescue drug for pain
Measured: At 2hrs or at the time of discharge from PACU
Mean Dose of Analgesic Used
For a day surgery case, from the time of hospital admittance to discharge from hospital is an average 5 hours.
Measured: 5 hours post-admit to hospital
Patient Satisfaction Score
Patient satisfaction is measured on a 0-10 visual analogue scale, where 0=completely unsatisfied; 10=extremely satisfied
Measured: At 5 hours post-admit to hospital
Time to Discharge From PACU
For a day surgery case, from the time out of operating room to discharge from PACU is an average 2 hours.
Measured: At 2hrs or at the time of discharge from PACU
Time to Discharge From Hospital
For a day surgery case, from the time of hospital admittance to discharge from hospital is an average 5 hours.
Measured: At 5 hours post-admit to hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startJan 2015
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harsha Shanthanna, MD, Principal investigator, St. Joseph's Healthcare Hamilton/McMaster UniversityJames Paul, MD, Principal investigator, Hamilton Health Sciences/McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223377
- Sponsor's protocol ID
- 14-482
- Other IDs
- CAS-2014-038
- Acronym
- SAME-Day
- Status last verified
- Jun 2026
- First submitted
- 19 Aug 2014
- Last updated
- 23 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22778673Troy AM, Cunningham AJ. Ambulatory surgery: an overview. Curr Opin Anaesthesiol. 2002 Dec;15(6):647-57. doi: 10.1097/00001503-200212000-00008.
PubMed 17019266Shnaider I, Chung F. Outcomes in day surgery. Curr Opin Anaesthesiol. 2006 Dec;19(6):622-9. doi: 10.1097/ACO.0b013e328010107e.
PubMed 17093366Macario 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.
PubMed 10475299Chatterjee 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.
PubMed 22110499White 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.
PubMed 18378964Felden 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.
PubMed 21841049Shanthanna H, Khaled MATM, Diaz A, Farsinejad P, Clements S. Low-dose remifentanil as an adjunct analgesic is not associated with clinically important opioid-induced hyperalgesia: secondary analysis from a randomized controlled trial. Reg Anesth Pain Med. 2025 Apr 24:rapm-2025-106483. doi: 10.1136/rapm-2025-106483. Online ahead of print.
PubMed 40274406Shanthanna H, Paul J, Lovrics P, Vanniyasingam T, Devereaux PJ, Bhandari M, Thabane L. Satisfactory analgesia with minimal emesis in day surgeries: a randomised controlled trial of morphine versus hydromorphone. Br J Anaesth. 2019 Jun;122(6):e107-e113. doi: 10.1016/j.bja.2019.03.036. Epub 2019 Apr 23.
PubMed 31027915Shanthanna H, Paul J, Lovrics P, Devereaux PJ, Bhandari M, Thabane L. Satisfactory Analgesia with Minimal Emesis in Day Surgeries (SAME DayS): a protocol for a randomised controlled trial of morphine versus hydromorphone. BMJ Open. 2018 Jun 22;8(6):e022504. doi: 10.1136/bmjopen-2018-022504.
PubMed 29934395
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Most Effective Opioid Analgesia in Ambulatory Surgeries: a Randomized Control, Investigator Blinded, Parallel Group With Superiority Design Study of Morphine Versus Hydromorphone
- ClinicalTrials.gov ID
- NCT02223377
- Acronym / sponsor ID
- SAME-Day / 14-482
- Conditions
- Pain, Post Operative Nausea and Vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 22 Aug 2014 (estimated)
- Results
- Posted 11 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morphine | Active comparator | Drug: MorphineAnalgesia 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) |
| Hydromorphone | Active comparator | Drug: HydromorphoneAnalgesia 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) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ambulatory surgeries producing at least moderate pain-such as cholecystectomy, appendicectomy, ovarian cystectomy, inguinal hernia repair, abdominal wall hernias
- ability to communicate in English.
Key exclusion criteria (8 listed)
- allergy to M or HM
- patient on regular chronic opioid medication
- patient uncontrolled systemic disease
- severe obesity with a BMI >35
- significant psychological impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MorphineAlso: Sandoz1st dose: syringe of 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 is administered. 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) | Drug | Morphine |
| HydromorphoneAlso: Sandoz1st dose: syringe of 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 is administered. 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) | Drug | Hydromorphone |
Primary outcome
Our Combined Primary Outcome Will be Number 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
Our combined primary outcome will be number 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.
8 secondary outcomes
Number of Patients With Severe Itching
Time frame: At 2hrs or at the time of discharge from PACU
Severe Sedation
Time frame: At 2hrs or at the time of discharge from PACU
Severe Respiratory Depression
Time frame: At 2hrs or at the time of discharge from PACU
Patients Requesting Oral Analgesia in the Day Surgery Unit
Time frame: At 2hrs or at the time of discharge from PACU
Mean Dose of Analgesic Used
Time frame: 5 hours post-admit to hospital
Patient Satisfaction Score
Time frame: At 5 hours post-admit to hospital
Time to Discharge From PACU
Time frame: At 2hrs or at the time of discharge from PACU
Time to Discharge From Hospital
Time frame: At 5 hours post-admit to hospital
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22778673Sarin 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.
- Background: PubMed 17019266Troy AM, Cunningham AJ. Ambulatory surgery: an overview. Curr Opin Anaesthesiol. 2002 Dec;15(6):647-57. doi: 10.1097/00001503-200212000-00008.
- Background: PubMed 17093366Shnaider I, Chung F. Outcomes in day surgery. Curr Opin Anaesthesiol. 2006 Dec;19(6):622-9. doi: 10.1097/ACO.0b013e328010107e.
- Background: PubMed 10475299Macario 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.
- Background: PubMed 22110499Chatterjee 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.
- Background: PubMed 18378964White 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.
- Background: PubMed 21841049Felden 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.
- Derived from this study: PubMed 40274406Shanthanna H, Khaled MATM, Diaz A, Farsinejad P, Clements S. Low-dose remifentanil as an adjunct analgesic is not associated with clinically important opioid-induced hyperalgesia: secondary analysis from a randomized controlled trial. Reg Anesth Pain Med. 2025 Apr 24:rapm-2025-106483. doi: 10.1136/rapm-2025-106483. Online ahead of print.
- Derived from this study: PubMed 31027915Shanthanna H, Paul J, Lovrics P, Vanniyasingam T, Devereaux PJ, Bhandari M, Thabane L. Satisfactory analgesia with minimal emesis in day surgeries: a randomised controlled trial of morphine versus hydromorphone. Br J Anaesth. 2019 Jun;122(6):e107-e113. doi: 10.1016/j.bja.2019.03.036. Epub 2019 Apr 23.
- Derived from this study: PubMed 29934395Shanthanna H, Paul J, Lovrics P, Devereaux PJ, Bhandari M, Thabane L. Satisfactory Analgesia with Minimal Emesis in Day Surgeries (SAME DayS): a protocol for a randomised controlled trial of morphine versus hydromorphone. BMJ Open. 2018 Jun 22;8(6):e022504. doi: 10.1136/bmjopen-2018-022504.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harsha Shanthanna, MD principal investigator
St. Joseph's Healthcare Hamilton/McMaster University
James Paul, MD principal investigator
Hamilton Health Sciences/McMaster University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morphine and Hydromorphone in people with Pain and Post Operative Nausea and Vomiting, run by McMaster University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Our Combined Primary Outcome Will be Number 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02223377, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.