Perioperative Methadone in Hip Fracture Patients - Dosage Adjusting Pilot-study

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Southern Denmark
• Treatments: Methadone

Criteria

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.