A Phase 4 interventional study of Methadone Hydrochloride and Placebo in Hip Fractures and Methadone, sponsored by University of Southern Denmark. Completed at 1 site in Denmark. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-03-18.
Sponsored by University of Southern Denmark · Phase 4, Interventional, and Treatment
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.
Studies investigating the perioperative use of methadone have shown promising analgesic properties. Our pilot study (EudraCT no.: 2022-001857-22) showed that a dosage of 0.10 mg/kg was safe to use and showed excellent analgesic properties. Sufficient management of acute postoperative pain is important in relation to morbidity, hospital costs, and mortality. About 60% of patients undergoing surgical intervention experience moderate to severe postoperative pain. Thus, sufficient analgesic treatment is crucial in the initial postoperative days, which are considered the most painful phase of recovery. Opioids have conventionally been used as an analgesic treatment in this phase. However, this treatment has been accompanied by side effects and addiction. Methadone shares these side effects, however, as methadone only needs to be administered once, the risk of side effects decreases significantly. This study will investigate the analgesic effects of a single dose of methadone given during hip fracture surgery.
The first objective is to investigate the analgesic effect of perioperative methadone compared with a placebo in acute hip fracture surgery. The second objective is to investigate the long-term effects of methadone on continued opioid consumption, pain, and mobility three months after surgery.
The null hypothesis is that there is no difference in postoperative pain, opioid consumption, or related side effects if a patient receives a dose of methadone or placebo during the surgery.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 129 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →University of Southern Denmark is the lead sponsor of 327 studies on the registry; 45 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
Methadone hydrochloride (0.10 mg/kg) administered intravenously at the induction of anaesthesia
Drug: Methadone Hydrochloride
Standard saline solution administered intravenously at the induction of anaesthesia
Other: Placebo
Methadone hydrochloride (0.10 mg/kg) administered intravenously at the induction of anaesthesia
Also known as: Methadone
Saline solution
Also known as: Saline
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.
Time frame: 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.
Time frame: 3 months post-surgery
Postoperative pain assessment with verbal rating scale (VRS)
Patients will be asked to assess pain intensity daily in the hip both at rest and when mobilized. Pain intensity will be evaluated using the verbal rating scale consisting of five choices - 1 (No pain), 2 (Slight pain), 3 (Moderate pain), 4 (Severe pain), and 5 (Unbearable pain).
Time frame: 3 days post-surgery
Time until patient first stands up post-surgery
This will be registered in hours and minutes. The minimum is 0 hours and 0 minutes and the maximum is 72 hours and 0 minutes.
Time frame: up to 72 hours post-surgery
Mobility assessment using the Cumulated Ambulation Score (CAS)
The cumulated ambulation score describes the patient's independence with regard to three activities. The first getting in and out of bed, the second ability to transition from sit-to-stand-to-sit from a chair, and the third is walking ability. Each of these activities is assessed on a three-point scale from 0-2 (0 = Not able to, despite human assistance and verbal cueing, 1 = Able to, with human assistance and/or verbal cueing from one or more persons, 2 = Able to safely, without human assistance or verbal cueing. A CAS score will range from zero (worst) to six (best) and will be measure daily.
Time frame: 3 days post-surgery
Number of patients with post operative nausea or vomiting (PONV)
Postoperative nausea or vomiting (PONV) will be registered binomial as "yes" or "no" once daily
Time frame: 3 days post-surgery
Number of days to discharge after surgery
The number of days from ward admission until discharge. Patients moved to another department are still considered hospitalized. The minimum is 0 days and the maximum is 14 days.
Time frame: From admission to the ward to discharge, up to 14 days
Number of patients requiring an antidote
Administration of an antidote will be registered binomial as "yes" or "no". Indications for the use of an antidote include a respiratory frequency of \<10/min with peripheral oxygenation of \<94% despite 4 liters of oxygen/minute, clinical signs of opioid overdose e.g. disproportionate drowsiness, or if the orthopaedic resident deems it necessary.
Time frame: 3 days post-surgery
Number of patients with delirium assessed using the Confusion Assessment Method (CAM)
Patients will be monitored using the confusion assessment method for signs of delirium. The method is binomial so that 0 means no signs of delirium and 1 means a patient is delirious.
Time frame: 3 days post-surgery
Number of participants with constipation
Occurrence of constipation during admission will be registered binomial as "yes" or "no". A patient with no bowel movements for ≥2 days is considered constipated.
Time frame: 3 days post-surgery
Postoperative pain assessment with verbal rating scale (VRS)
Patients will be asked to assess pain intensity daily in the hip both at rest and when mobilized. Pain intensity will be evaluated using the verbal rating scale consisting of five choices - 1 (No pain), 2 (Slight pain), 3 (Moderate pain), 4 (Severe pain), and 5 (Unbearable pain).
Time frame: 3 months post-surgery
Quality of life assessed using EQ-5D-5L questionnaire
The questionnaire comprises of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Time frame: 3 months post-surgery
Patient mobility assessed using the new mobility score (NMS)
New mobility score assesses gait; inside the home, outside the home and whilst shopping. A score of 0-3 points is given for each of these three functions, resulting in a total score between 0-9 points.
Time frame: 3 months post-surgery
Number of persistent side effects
The persistent presence of potential adverse reactions will be registered. This includes disproportional dizziness, vertigo, nausea, vomiting, constipation, and drowsiness.
Time frame: 3 months post-surgery
Plan to share: No
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University of Southern Denmark