Standard Care morphine hydrochloride
DrugPost-operative analgesia including morphine (patient controlled analgesia).
Other names: morphine hydrochloride
NCT Number: NCT01536301
The main objective is to demonstrate that postoperative analgesia by IV oxycodone (compared to morphine IV) reduces opioid-related adverse events (nausea, vomiting, pruritus, respiratory depression, urinary retention, allergies, hallucination) by 50% in adult patients operated on for prosthetic hip surgery.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 4
CHU de Nîmes - Hôpital Universitaire Carémeau, Nîmes, Gard, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Post-operative analgesia including morphine (patient controlled analgesia).
Other names: morphine hydrochloride
Post-operative analgesia including oxycodone (patient controlled analgesia).
Other names: oxycodone hydrochloride
Time frame: 24 hours
The presence/absence of at least one of the following complications: nausea, vomiting, respiratory depression, pruritus (itch), urinary retention requiring evacuation (spontaneous voiding impossible despite bladder volume> 400 ml measured by ultrasound), allergy (skin reaction, hallucination (perception without object).
Drowsiness (Ramsay score) is not considered an adverse event within the primary endpoint.
Time frame: Day 1
Time frame: Day 1
Time frame: Day 1
Time frame: 24 hours
Time frame: Day 1
Time frame: Day 2
Time frame: Day 3
Time frame: Day 1
Time frame: Day 2
Time frame: Day 3
Time frame: Day 1
Time frame: Day 2
Time frame: Day 3
Time frame: Day 1
Time frame: Day 2
Time frame: Day 3
Time frame: Day 1
nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation
Time frame: Day 2
nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation
Time frame: Day 3
nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation
Time frame: Hospital discharge
Time frame: 4 months
Time frame: Day -1 (before intervention)
Time frame: Day 1
Time frame: Day 2
Time frame: Day 3
Time frame: Day -1 (before intervention)
Time frame: 4 months
Time frame: Day 3
Centre Hospitalier Universitaire de Nīmes
Other
Evaluation of Oxycodone Hydrochloride Versus Intravenous Morphine Hydrochloride for Postoperative Analgesia After Hip Prosthetic Surgery
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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