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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004140-22 | EudraCT Number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morphine | Active Comparator | The patients in this arm will have post-operative analgesia including morphine (patient controlled analgesia). |
|
| Oxycodone | Experimental | The patients in this arm will have post operative analgesia including oxycodone (patient controlled analgesia). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Care morphine hydrochloride | Drug | Post-operative analgesia including morphine (patient controlled analgesia). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite score of complications | 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. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of opioid boluses in the post-intervention surveillance room | Day 1 | |
| Time to obtain a VAS score < 30/100 (from the first administration; minutes) | Day 1 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lana Zoric, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Philippe Cuvillon, MD | Centre Hospitalier Universitaire de Nīmes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | Gard | 30029 | France | ||
| APHP - Groupe Hospitalier Pitié-Salpetrière |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32790073 | Result | Cuvillon P, Alonso S, L'Hermite J, Reubrecht V, Zoric L, Vialles N, Luc Faillie J, Kouyoumdjian P, Boisson C, Raux M, Langeron O. Post-operative opioid-related adverse events with intravenous oxycodone compared to morphine: A randomized controlled trial. Acta Anaesthesiol Scand. 2021 Jan;65(1):40-46. doi: 10.1111/aas.13685. Epub 2020 Sep 27. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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| Oxycodone | Drug | Post-operative analgesia including oxycodone (patient controlled analgesia). |
|
|
| Length of stay in the post-intervention surveillance room (minutes) |
| Day 1 |
| Total dose of opioids during the first 24 hours (mg) | 24 hours |
| Total number of opioid requestions (patient controlled analgesia = PCA) | Day 1 |
| Total number of opioid requestions (patient controlled analgesia = PCA) | Day 2 |
| Total number of opioid requestions (patient controlled analgesia = PCA) | Day 3 |
| Total number of opioid requestions accepted / refused (PCA) | Day 1 |
| Total number of opioid requestions accepted / refused (PCA) | Day 2 |
| Total number of opioid requestions accepted / refused (PCA) | Day 3 |
| Ramsay score | Day 1 |
| Ramsay score | Day 2 |
| Ramsay score | Day 3 |
| Presence / absence of an overdose of morphine/oxycodone (Ramsay score > 4) | Day 1 |
| Presence / absence of an overdose of morphine/oxycodone (Ramsay score> 4) | Day 2 |
| Presence / absence of an overdose of morphine/oxycodone (Ramsay score> 4) | Day 3 |
| Presence/absence of complications | nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation | Day 1 |
| Presence/absence of complications | nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation | Day 2 |
| Presence/absence of complications | nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation | Day 3 |
| Patient satisfaction, VAS scale | Hospital discharge |
| Patient satisfaction, VAS scale | 4 months |
| Pain while at rest at while moving (Visual Analog Scale) | Day -1 (before intervention) |
| Pain while at rest at while moving (Visual Analog Scale) | Day 1 |
| Pain while at rest at while moving (Visual Analog Scale) | Day 2 |
| Pain while at rest at while moving (Visual Analog Scale) | Day 3 |
| DN4 score | Day -1 (before intervention) |
| DN4 score | 4 months |
| Length of hospital stay (hours) | Day 3 |
| Paris |
| 75013 |
| France |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |