Trial Outcomes & Findings for Methadone Versus Morphine for Orthopedic Surgery Patients (NCT NCT00892606)

NCT ID: NCT00892606

Last Updated: 2017-06-14

Results Overview

The amount of opioid required for postoperative pain relief

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 75 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2017-06-14

Participant Flow

Participant milestones

Measure	Methadone Patients will receive 0.2 mg/kg of methadone IV immediately after intubation Methadone: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation	Control Patient will receive current standard-of-care: 0.2 mg/kg of morphine IV immediately after intubation Morphine: Patients will receive 0.2 mg/kg of morphine IV immediately after intubation
Overall Study STARTED	38	37
Overall Study COMPLETED	33	33
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Methadone Versus Morphine for Orthopedic Surgery Patients

Baseline characteristics by cohort

Measure	Methadone n=38 participants Patients received 2 µg/kg fentanyl, 0.2 mg/kg ketamine, and 0.2 mg/kg of methadone IV immediately after intubation	Control n=37 participants Patients received 2 µg/kg fentanyl, 0.2 mg/kg ketamine, and 0.2 mg/kg morphine	Total n=75 participants Total of all reporting groups
Age, Continuous	37 years STANDARD_DEVIATION 13 • n=5 Participants	35 years STANDARD_DEVIATION 12 • n=7 Participants	36 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	27 Participants n=7 Participants	58 Participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants	37 participants n=7 Participants	75 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

The amount of opioid required for postoperative pain relief

Outcome measures

Measure	Methadone n=33 Participants Patients will receive 0.2 mg/kg of methadone IV immediately after intubation Methadone: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation	Control n=33 Participants Patient will receive current standard-of-care: 0.2 mg/kg of morphine IV immediately after intubation Morphine: Patients will receive 0.2 mg/kg of morphine IV immediately after intubation
Opioid Consumption During the 48 Hours After Surgery	51 mg Standard Deviation 19	87 mg Standard Deviation 40

SECONDARY outcome

Timeframe: 48 hours

rates subjects experienced PONV

Outcome measures

Measure	Methadone n=33 Participants Patients will receive 0.2 mg/kg of methadone IV immediately after intubation Methadone: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation	Control n=33 Participants Patient will receive current standard-of-care: 0.2 mg/kg of morphine IV immediately after intubation Morphine: Patients will receive 0.2 mg/kg of morphine IV immediately after intubation
Number of Participants With Post Operative Nausea and Vomiting	9 Participants	3 Participants

SECONDARY outcome

Timeframe: 48 hours

Patients rated their pain with the numerical VPS from 0 to 10, with 10 being the worst pain possible and 0 being no pain

Outcome measures

Measure	Methadone n=33 Participants Patients will receive 0.2 mg/kg of methadone IV immediately after intubation Methadone: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation	Control n=33 Participants Patient will receive current standard-of-care: 0.2 mg/kg of morphine IV immediately after intubation Morphine: Patients will receive 0.2 mg/kg of morphine IV immediately after intubation
Visual Pain Score	5 units on a scale Standard Deviation 3	6 units on a scale Standard Deviation 2

Adverse Events

Methadone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nancy Alsip

University Louisville

Phone: 502-852-2905

Email: nlalsi01@exchange.louisville.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place