Phase 4 Completed N=75 Randomized Triple-blind Treatment

Methadone Versus Morphine for Orthopedic Surgery Patients

Fracture · Pain, Postoperative

Source: ClinicalTrials.gov NCT00892606 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2017

Primary outcomePrimary: Opioid Consumption During the 48 Hours After Surgery — 51; 87 mg — p=0.0072

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

The investigators propose to compare analgesia by methadone and ketamine with a combination of morphine and ketamine in orthopedic surgery patients with moderate to severe pain. The investigators hypothesize that when given with ketamine before surgical incision, methadone is more effective than morphine in reducing postoperative morphine consumption and reducing pain during movement.

Outcome Measures

Outcome	Result	p-value
PRIMARY Opioid Consumption During the 48 Hours After Surgery	51; 87	0.0072 sig
SECONDARY Number of Participants With Post Operative Nausea and Vomiting	9; 3	0.004 sig
SECONDARY Visual Pain Score	5; 6	0.0146 sig

Eligibility Criteria

Inclusion Criteria

ASA I-III
Ages 18-65 years
Presenting for lower extremity orthopedic surgery involving fracture of long bones at University of Louisville Hospital
Surgery expected to last more than one hour
Patient expected to have moderate to severe post-operative pain
Patient refused regional anesthesia or has a contraindication to regional anesthesia

Exclusion Criteria

Any known contraindications to methadone including hypothyroidism, Addison's disease, prostatic hypertrophy, or urethral stricture.
Difficulty or inability to understand the study or protocol
Known renal or hepatic dysfunction
BMI> 35
Known respiratory or cardiovascular problems, such as obstructive sleep apnea or oxygen saturation of less than 92% on room air
Taking any of the known drugs that induce or inhibit the cytochrome p450 enzyme systems. Common examples of these drugs are antifungal, antiretroviral, barbiturates, dexamethasone, and macrolide antibiotics.
Pregnancy
Taking preoperative opioids for more than 2 weeks before the surgery

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00892606). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.