Pain, Postoperative Clinical Trial
Official title:
Perioperative Methadone for Ameliorating Postoperative Pain and Reduction in Postoperative Opioid Consumption in Hip Fracture Patients - Dosage Adjusting Pilot-study
Verified date | April 2023 |
Source | University of Southern Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Postoperative analgesic treatment needs to be improved. Numerous studies suggest that a single dose of Methadone given during surgery significantly ameliorates postoperative pain and reduces postoperative opioid consumption. Perioperative methadone is already used in isolated cases such as patients with chronic pain or patients with high morphine tolerance. However, it is not routinely used in the elderly and fragile, and there is insufficient reliable evidence on this treatment and population. Further investigation is highly relevant and necessary.
Status | Completed |
Enrollment | 31 |
Est. completion date | April 4, 2023 |
Est. primary completion date | March 23, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: - Patients diagnosed with a hip fracture on x-rays (collum femoris fractures, pertrochanteric fractures and subtrochanteric fractures). - Patients must be able to reliably assess their level of pain using the VRS and be able to ask for supplementary analgesics if needed. - Patients must understand the information given and be able to read and speak Danish. - Patients must be able to give informed consent. Exclusion Criteria: - Polytrauma (defined as a trauma with one or more absolute indications for surgical intervention). - Previous allergic reactions or hypersensitivity towards Methadone hydrochloride or Sodium-chloride. - Health conditions preventing treatment, i.e. chronic obstructive pulmonary disease (Gold classification C+D), history with acute asthma attacks or atopic skin conditions, cor pulmonale, raised intracranial pressure or head injury, Pheochromocytoma, history with paralytic ileus, QT interval prolongation, myasthenia gravis, liver disorders or hypotension. - Concurrent administration with monoamine oxidase inhibitors or within 2 weeks of suspending treatment with these medicinal products. - Concurrent administration of sedatives, e.g. Benzodiazepines or related drugs. - Included in other studies (e.g., SENSE-trial). - Known cognitive disorders e.g., dementia. - Current drug addiction e.g., opioid addiction or intravenous addiction. |
Country | Name | City | State |
---|---|---|---|
Denmark | Sygehus Soenderjylland | Aabenraa |
Lead Sponsor | Collaborator |
---|---|
University of Southern Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Respiratory depression | Occurrence of a respiratory frequency <10/min and oxygen saturation <94 % despite 4 liters of oxygen/min. | 6 hours after surgery | |
Primary | Respiratory depression | Occurrence of a respiratory frequency <10/min and oxygen saturation <94 % despite 4 liters of oxygen/min. | 24 hours after surgery | |
Primary | Respiratory depression | Occurrence of a respiratory frequency <10/min and oxygen saturation <94 % despite 4 liters of oxygen/min. | 72 hours after surgery | |
Secondary | Length of stay at the post anaesthetic care unit | Hours | up to 12 hours after surgery | |
Secondary | Number of times Naloxone was administered | Numerical | immediately after the surgery (6, 24, 72 hours) | |
Secondary | Postoperative opioid consumption | mean consumption of rescue medication | immediately after the surgery (6, 24, 72 hours) | |
Secondary | Opioid-related side-effects | Opioid-related side-effects will be registered binomial as nausea and vomiting | immediately after the surgery (6, 24 hours) | |
Secondary | Postoperative pain | Patients will be asked to assess pain intensity at the time of arrival from the post-anaesthesia care unit using the Verbal Rating Scale (VRS) consisting of 6 categories where 0 is no pain and 5 is the highest level of pain (worst outcome). | immediately after the surgery (0, 6, 24, 72 hours) |
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