Overview

This trial is active, not recruiting.

Condition nausea
Treatments oxycodone, hydromorphone
Phase phase 4
Sponsor University Health Network, Toronto
Start date August 2012
End date June 2017
Trial size 200 participants
Trial identifier NCT02295124, 12-0267-AE

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
Arm
(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.
oxycodone Supeudol
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.
(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.
hydromorphone Palladone, Dilaudid
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.

Primary Outcomes

Measure
The occurrence of postoperative nausea
time frame: Participants will be followed for the duration of hospital stay, an expected average of 72 hours

Secondary Outcomes

Measure
Daily pain scores
time frame: 72 hours after surgery
Incidence of opioid related itching
time frame: 72 hours after surgery
Incidence of delirium
time frame: 72 hours after surgery
Cumulative in-hospital opioid consumption
time frame: 72 hours after surgery
Use of anti-nausea medications
time frame: 72 hours after surgery
Cumulative drug costs per patient
time frame: 72 hours after surgery
Post-operative admission duration
time frame: Total admission duration, an expected average of 72 hours

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title Nausea in Patients Receiving Hydromorphone vs Oxycodone After Total Hip Replacement Surgery
Principal investigator Richard Brull, MD
Description Nausea and vomiting in the post-operative period is considered strongly undesirable by patients and has adverse effects on recovery from outpatient procedures, contributing significantly to delays in discharge from recovery. A know major contributor to the occurrence of post-operative nausea and vomiting is the use of opiate medications which are the cornerstone of post-operative pain management. The investigators hypothesize that the occurrence of this side-effect is different between patients prescribed oxycodone and those receiving hydromorphone for acute pain management after total hip replacement surgery. This investigation is a randomized, double-blind, head-to-head comparison to equipotent administration of oxycodone vs. hydromorphone to determine whether such a difference exists.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.