- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02223377
Satisfactory Analgesia Minimal Emesis in Day Surgeries (SAME-Day)
Most Effective Opioid Analgesia in Ambulatory Surgeries: a Randomized Control, Investigator Blinded, Parallel Group With Superiority Design Study of Morphine Versus Hydromorphone
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N 4A6
- St. Joseph's Healthcare Hamilton
-
Hamilton, Ontario, Canada, L8L 2X2
- Hamilton Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ambulatory surgeries producing at least moderate pain-such as cholecystectomy, appendicectomy, ovarian cystectomy, inguinal hernia repair, abdominal wall hernias
- ability to communicate in English.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Morphine
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) |
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)
Other Names:
|
Active Comparator: Hydromorphone
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) |
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)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At 2hrs or at the time of discharge from PACU
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severe Respiratory Depression
Time Frame: At 2hrs or at the time of discharge from PACU
|
Presence of Respiratory Rate below 10 and/or Presence of Oxygen Saturation <90
|
At 2hrs or at the time of discharge from PACU
|
Number of Patients With Severe Itching
Time Frame: At 2hrs or at the time of discharge from PACU
|
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
|
At 2hrs or at the time of discharge from PACU
|
Severe Sedation
Time Frame: At 2hrs or at the time of discharge from PACU
|
Ramsay Sedation Scale 0-6
|
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
|
Use of rescue drug for pain
|
At 2hrs or at the time of discharge from PACU
|
Mean Dose of Analgesic Used
Time Frame: 5 hours post-admit to hospital
|
For a day surgery case, from the time of hospital admittance to discharge from hospital is an average 5 hours.
|
5 hours post-admit to hospital
|
Patient Satisfaction Score
Time Frame: At 5 hours post-admit to hospital
|
Patient satisfaction is measured on a 0-10 visual analogue scale, where 0=completely unsatisfied; 10=extremely satisfied
|
At 5 hours post-admit to hospital
|
Time to Discharge From PACU
Time Frame: At 2hrs or at the time of discharge from PACU
|
For a day surgery case, from the time out of operating room to discharge from PACU is an average 2 hours.
|
At 2hrs or at the time of discharge from PACU
|
Time to Discharge From Hospital
Time Frame: At 5 hours post-admit to hospital
|
For a day surgery case, from the time of hospital admittance to discharge from hospital is an average 5 hours.
|
At 5 hours post-admit to hospital
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James Paul, MD, Hamilton Health Sciences/McMaster University
- Principal Investigator: Harsha Shanthanna, MD, St. Joseph's Healthcare Hamilton/McMaster University
Publications and helpful links
General Publications
- 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.
- 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.
- Shnaider I, Chung F. Outcomes in day surgery. Curr Opin Anaesthesiol. 2006 Dec;19(6):622-9. doi: 10.1097/ACO.0b013e328010107e.
- 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.
- Troy AM, Cunningham AJ. Ambulatory surgery: an overview. Curr Opin Anaesthesiol. 2002 Dec;15(6):647-57. doi: 10.1097/00001503-200212000-00008.
- 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.
- 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.
- Shanthanna 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.
- Shanthanna 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Postoperative Nausea and Vomiting
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Morphine
- Hydromorphone
Other Study ID Numbers
- 14-482
- CAS-2014-038 (Other Grant/Funding Number: AbbVie New Investigator's Award, CAS)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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