Perioperative Methadone Compared to Placebo in Elderly Hip Fracture Patients

NCT06086171 | Completed Phase 4

• 1 other identifier: SHS-An-4-2023
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

Hip fractures are associated with severe pain and are sustained by the elderly population. Demand for adequate pain relief combined with a low tolerance for analgesic drugs makes the treatment of elderly hip fracture patients difficult. Perioperative methadone could improve the analgesic treatment of these patients. An earlier pilot study showed that 0.10 mg/kg was safe to use. This study further investigates the advantages of methadone. The study's objective is to investigate the analgesic effects of a single dose of methadone given during hip fracture surgery.

Conditions

Hip Fractures; Methadone

Keywords

Hip fractures; Elderly; Fragile; methadone; perioperative; analgesic treatment; pain; verbal rating scale; morphine consumption

Outcome Measures

Primary Outcomes (2)

• Consumption of daily morphine equivalents 3 days post operatively

  All opioids (short-acting and long-acting) will be converted into daily morphine milligram equivalent doses. The amount of opioids used by the patient within the last 24 hours will be registered daily. A minimum amount of 0 mg and a maximum amount of 150 mg can be recorded.

  3 days post-surgery

• Consumption of daily morphine equivalents 3 months post operatively

  The opioid consumption will be registered as a mean daily consumption of both long-acting opioids and rescue medication prescribed in the medication chart and reported by the patient. Different types of opioids will be converted into the daily morphine milligram equivalent dose. Minimum score will be 0 mg and the maximum will be 150 mg.

  3 months post-surgery

Secondary Outcomes (12)

• Postoperative pain assessment with verbal rating scale (VRS)

  3 days post-surgery

• Time until patient first stands up post-surgery

  up to 72 hours post-surgery

• Mobility assessment using the Cumulated Ambulation Score (CAS)

  3 days post-surgery

• Number of patients with post operative nausea or vomiting (PONV)

  3 days post-surgery

• Number of days to discharge after surgery

  From admission to the ward to discharge, up to 14 days

Study Arms (2)

Methadone

EXPERIMENTAL

Methadone hydrochloride (0.10 mg/kg) administered intravenously at the induction of anaesthesia

Drug: Methadone Hydrochloride

Placebo

PLACEBO COMPARATOR

Standard saline solution administered intravenously at the induction of anaesthesia

Other: Placebo

Interventions

Methadone Hydrochloride DRUG

Methadone hydrochloride (0.10 mg/kg) administered intravenously at the induction of anaesthesia

Also known as: Methadone

Methadone

Placebo OTHER

Saline solution

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with an acute hip fracture (incurred \<24 hours ago) on x-rays in the emergency department (ED) at the university hospital of southern Denmark (SHS). This includes collum femoris fractures, pertrochanteric fractures, and subtrochanteric fractures.
• Patients must be able to read and understand Danish.

You may not qualify if:

• Multiple fractures or multi-trauma patient
• Previous allergic reactions or hypersensitivity towards methadone hydrochloride or sodium chloride
• Health conditions preventing treatment:
• Chronic obstructive pulmonary disease with either past exacerbations or daily symptoms History of acute asthma attacks History of drug-induced eczema Pulmonary hypertension Raised intracranial pressure or recent head injury Pheochromocytoma History of paralytic ileus QT-interval prolongation on electrocardiogram (ECG) Myasthenia gravis Known liver disorder Hypotension (systolic blood pressure \<100 mmHg at admission) Acute pancreatitis Severe kidney disease (GFR ≤10)
• Concurrent administration with MAO inhibitors or within 2 weeks of suspending treatment with these medicinal products
• Concurrent administration of benzodiazepines
• Impaired cognitive function e.g. dementia. Patients must be able to give informed consent and be able to ask for rescue analgesics if needed
• Current opioid addiction or intravenous addiction

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Sygehus Sønderjylland

Aabenraa, Southern Denmark, 6200, Denmark

Location

Related Publications (1)

• Nygaard KH, Strom T, Specht K, Petersen SR, Schonnemann JO. Perioperative methadone compared to placebo in elderly hip fracture patients: a study protocol for a randomized controlled trial (MetaHip trial). Trials. 2024 Dec 20;25(1):842. doi: 10.1186/s13063-024-08694-6.

  PMID: 39707407 DERIVED

MeSH Terms

Conditions

Hip Fractures; Pain

Interventions

Methadone; Sodium Chloride

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jesper Ougaard Schønnemann

  Sygehus Sønderjylland (Region Syddanmark)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 17, 2023
• Study Start: November 10, 2023
• Primary Completion: October 29, 2024
• Study Completion: February 21, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)