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

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ClinicalTrials.gov Identifier: NCT02295124
Recruitment Status : Completed
First Posted : November 20, 2014
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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

Condition or disease Intervention/treatment Phase
Nausea Drug: Oxycodone Drug: Hydromorphone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nausea in Patients Receiving Hydromorphone vs Oxycodone After Total Hip Replacement Surgery
Actual Study Start Date : August 2012
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016


Arm Intervention/treatment
Active Comparator: Oxycodone
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
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.
Other Name: Supeudol

Active Comparator: Hydromorphone
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
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.
Other Name: Palladone, Dilaudid




Primary Outcome Measures :
  1. The occurrence of postoperative nausea [ Time Frame: 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 Outcome Measures :
  1. Daily pain scores [ Time Frame: 72 hours after surgery ]
    Pain scores (0-10) will be recorded twice daily until 72 hours post-operatively

  2. Incidence of opioid related itching [ Time Frame: 72 hours after surgery ]
    The presence or absence of the opioid related side effects will be recorded twice daily until 72 hours post-operatively

  3. Incidence of delirium [ Time Frame: 72 hours after surgery ]
    The presence of delirium will be recorded until 72 hours post-operatively

  4. Cumulative in-hospital opioid consumption [ Time Frame: 72 hours after surgery ]
    Total in-hospital opioid consumption in morphine equivalent doses will be calculated for the first 72 hours post-operatively

  5. Use of anti-nausea medications [ Time Frame: 72 hours after surgery ]
    The number of administrations and doses of anti-nausea medications will be evaluated until 72 hours post-operatively

  6. Cumulative drug costs per patient [ Time Frame: 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

  7. Post-operative admission duration [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295124


Locations
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Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Richard Brull, MD University of Toronto. University Health Network. Toronto Western Hospital.

Publications:
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02295124     History of Changes
Other Study ID Numbers: 12-0267-AE
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017

Keywords provided by University Health Network, Toronto:
Nausea

Additional relevant MeSH terms:
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Oxycodone
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Hydromorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents