Nausea in Patients Receiving Hydromorphone vs Oxycodone After Total Hip Replacement Surgery

NCT02295124 | Completed Phase 4

• 1 other identifier: 12-0267-AE
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to compare the incidence of side effects caused by Oxycodone and Hydromorphone.

Conditions

Nausea

Keywords

Nausea

Outcome Measures

Primary Outcomes (1)

• The occurrence of postoperative nausea

  The incidence and severity of nausea will be recorded twice daily up to 72 hours post-operatively

  Participants will be followed for the duration of hospital stay, an expected average of 72 hours

Secondary Outcomes (7)

• Daily pain scores

  72 hours after surgery

• Incidence of opioid related itching

  72 hours after surgery

• Incidence of delirium

  72 hours after surgery

• Cumulative in-hospital opioid consumption

  72 hours after surgery

• Use of anti-nausea medications

  72 hours after surgery

Study Arms (2)

Oxycodone

ACTIVE COMPARATOR

Patients will be prescribed oxycodone 10mg (5mg if \> age 65) every 2 hours as needed for post-operative pain management in addition to tylenol 1000mg every 6 hours and celecoxib 200mg every 12 hours.

Drug: Oxycodone

Hydromorphone

ACTIVE COMPARATOR

Patients will be prescribed hydromorphone 2mg (1mg if \> age 65) every 2 hours as needed in addition to tylenol 1000mg every 6 hours and celecoxib 200mg every 12 hours.

Drug: Hydromorphone

Interventions

Oxycodone DRUG

Patients will receive oxycodone 10mg (5mg if \> 65) every 2 hours based on an equianalgesic dose calculation. As per routine practice, the dose will be titrated according to the patient's pain at the discretion of the Acute Pain Service physician who will not be blinded to group allocation.

Also known as: Supeudol

Oxycodone

Hydromorphone DRUG

Patients will receive an initial dose of hydromorphone 2mg (1mg if \> 65) every 2 hours as needed based on an equianalgesic dose calculation. As per routine practice, the dose will be titrated according to the patient's pain at the discretion of the Acute Pain Service physician who will not be blinded to group allocation.

Also known as: Palladone, Dilaudid

Hydromorphone

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists Physical Status Classification System 1-3
• Age 18-85 years
• Patients undergoing hip replacement surgery under spinal anesthesia

You may not qualify if:

• patient refusal
• contraindication or refusal of spinal anesthesia
• inability to provide informed consent
• history of dementia
• intolerance or allergy to oxycodone or hydromorphone
• chronic opioid use or chronic pain disorder
• pregnancy
• history of drug addiction
• history of major psychiatric illness

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (3)

• 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

• Pavlin DJ, Rapp SE, Polissar NL, Malmgren JA, Koerschgen M, Keyes H. Factors affecting discharge time in adult outpatients. Anesth Analg. 1998 Oct;87(4):816-26. doi: 10.1097/00000539-199810000-00014.

  PMID: 9768776 BACKGROUND

• Hartrick C, Van Hove I, Stegmann JU, Oh C, Upmalis D. Efficacy and tolerability of tapentadol immediate release and oxycodone HCl immediate release in patients awaiting primary joint replacement surgery for end-stage joint disease: a 10-day, phase III, randomized, double-blind, active- and placebo-controlled study. Clin Ther. 2009 Feb;31(2):260-71. doi: 10.1016/j.clinthera.2009.02.009.

  PMID: 19302899 BACKGROUND

MeSH Terms

Conditions

Nausea

Interventions

Oxycodone; Hydromorphone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Codeine; 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

Study Officials

• Richard Brull, MD

  University of Toronto. University Health Network. Toronto Western Hospital.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2013
• First Posted: November 20, 2014
• Study Start: August 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: November 27, 2017

Record last verified: 2017-11

Locations

CA (1)