Nausea
Conditions
Keywords
Nausea
Brief summary
The study aims to compare the incidence of side effects caused by Oxycodone and Hydromorphone.
Detailed 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.
Interventions
DRUGOxycodone
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.
DRUGHydromorphone
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.
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The occurrence of postoperative nausea | Participants will be followed for the duration of hospital stay, an expected average of 72 hours | The incidence and severity of nausea will be recorded twice daily up to 72 hours post-operatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of opioid related itching | 72 hours after surgery | The presence or absence of the opioid related side effects will be recorded twice daily until 72 hours post-operatively |
| Incidence of delirium | 72 hours after surgery | The presence of delirium will be recorded until 72 hours post-operatively |
| Cumulative in-hospital opioid consumption | 72 hours after surgery | Total in-hospital opioid consumption in morphine equivalent doses will be calculated for the first 72 hours post-operatively |
| Daily pain scores | 72 hours after surgery | Pain scores (0-10) will be recorded twice daily until 72 hours post-operatively |
| Cumulative drug costs per patient | 72 hours after surgery | The cumulative drug cost based on all anti-nausea and analgesic medications administered will be calculated for the first 72 hours post-operatively |
| Post-operative admission duration | Total admission duration, an expected average of 72 hours | The number of post-operative days required for admission will be assessed. Duration is to be an expected average of 72 hours |
| Use of anti-nausea medications | 72 hours after surgery | The number of administrations and doses of anti-nausea medications will be evaluated until 72 hours post-operatively |
Countries
Canada
Outcome results
None listed