Satisfactory Analgesia Minimal Emesis in Day Surgeries

NCT02223377 | Completed Results

• 2 other identifiers: 14-482CAS-2014-038
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Pain; Post Operative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• 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.

  At 2hrs or at the time of discharge from PACU

Secondary Outcomes (8)

• Number of Patients With Severe Itching

  At 2hrs or at the time of discharge from PACU

• Severe Sedation

  At 2hrs or at the time of discharge from PACU

• Severe Respiratory Depression

  At 2hrs or at the time of discharge from PACU

• Patients Requesting Oral Analgesia in the Day Surgery Unit

  At 2hrs or at the time of discharge from PACU

• Mean Dose of Analgesic Used

  5 hours post-admit to hospital

Study Arms (2)

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)

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)

Drug: Hydromorphone

Interventions

Morphine DRUG

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)

Also known as: Sandoz

Morphine

Hydromorphone DRUG

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)

Also known as: Sandoz

Hydromorphone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ambulatory surgeries producing at least moderate pain-such as cholecystectomy, appendicectomy, ovarian cystectomy, inguinal hernia repair, abdominal wall hernias
• ability to communicate in English.

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (2)

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• Shnaider I, Chung F. Outcomes in day surgery. Curr Opin Anaesthesiol. 2006 Dec;19(6):622-9. doi: 10.1097/ACO.0b013e328010107e.

  PMID: 17093366 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Shanthanna 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.

  PMID: 40274406 DERIVED

• 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.

  PMID: 31027915 DERIVED

• 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.

  PMID: 29934395 DERIVED

MeSH Terms

Conditions

Pain; Vomiting

Interventions

Morphine; Hydromorphone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Thuvaraha Vanniyasingam
• Organization: Department of Anesthesia, McMaster University, Canada

tvanniya@stjosham.on.ca

(905) 525-9140

Study Officials

• Harsha Shanthanna, MD

  St. Joseph's Healthcare Hamilton/McMaster University

  PRINCIPAL INVESTIGATOR

• James Paul, MD

  Hamilton Health Sciences/McMaster University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: August 22, 2014
• Study Start: January 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: December 11, 2023
• Results First Posted: December 11, 2023

Record last verified: 2023-03

Locations

CA (2)