Methadone in Ambulatory Surgery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2018-02-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The μ-opioid receptor agonist methadone is frequently used in adult anesthesia and adult pain therapy. Methadone has an extremely long half-life, which confers therapeutic advantage by providing more stable plasma concentrations and long-lasting pain relief. Methadone perioperative pharmacokinetics and effectiveness in perioperative pain relief in inpatients is well characterized. There is, however, no information on methadone use in an ambulatory surgery setting and outpatient procedures. This pilot investigation will determine effectiveness of intraoperative methadone in reducing postoperative opioid consumption and providing improved pain relief in patients undergoing moderately painful, ambulatory surgical procedures.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intraoperative Methadone for the Prevention of Postoperative Pain

NCT05831345

Orthopedic Surgery

RECRUITING PHASE3

Preoperative Oral Methadone for Patients Undergoing Cardiac Surgery: Reduction of Postoperative Pain

NCT02774499

Pain

COMPLETED PHASE2

Oral Methadone in Cardiac Surgery

NCT07221617

Pain, Postoperative Anesthesia Cardiac Surgery

RECRUITING PHASE4

Methadone Pharmacokinetics in Cardiac Surgery

NCT07226245

Postoperative Pain Management

NOT_YET_RECRUITING PHASE4

Oral and Intravenous Methadone for Analgesia in Cardiac Surgery

NCT06720415

Anesthesia Cardiac Surgery

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post-operative Pain Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Control (Intra-operative administration of opioids, other than methadone)

Group Type ACTIVE_COMPARATOR

Control (Intra-operative administration of opioids, other than methadone)

Intervention Type DRUG

Intra-operative administration of opioids, other than methadone

Treatment methadone 0.1 mg/kg

methadone 0.1 mg/kg

Group Type ACTIVE_COMPARATOR

methadone

Intervention Type DRUG

Escalating dose of methadone up to .3mg/kg.

Treatment methadone 0.15 mg/kg

Group Type ACTIVE_COMPARATOR

methadone

Intervention Type DRUG

Escalating dose of methadone up to .3mg/kg.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

methadone

Escalating dose of methadone up to .3mg/kg.

Intervention Type DRUG

Control (Intra-operative administration of opioids, other than methadone)

Intra-operative administration of opioids, other than methadone

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Dolophine morphine fentanyl

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 18-65 years
* Undergoing general anesthesia and moderately painful, ambulatory surgical procedures with anticipated overnight, postop hospital stay of \< 24 hours
* Signed, written, informed consent

Exclusion Criteria

* History of or known liver or kidney disease.
* Females who are pregnant or nursing.
* Opioid tolerant patients (e.g. preoperative methadone therapy or use of fentanyl transdermal patches)
* History of allergy to methadone

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No