Methadone vs. Fentanyl Administration on Postoperative Pain Control in Pediatric Patients Undergoing Cardiac Surgery

Stopped early · Not applicable

Conditions studied: Opioid Use, Unspecified

In brief

The purpose of this study is to determine if methadone improves postoperative pain control in pediatric patient's undergoing cardiac surgery.

Key facts

Study ID

NCT02747875

Run by

Andrew Waberski

People needed

26

Starts

2016-09-01

Expected to finish

2019-02-07

Last updated by the study team

2021-06-01

Who can join

Age: 2 and older, up to 7. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age greater than or equal to 2 years and less than 8 years at the time of randomization.
• Weight greater than 6 kg.
• American Society of Anesthesiologists (ASA) physical status of ASA I, II, or III (Appendix I).
• Informed consent to participate from the parent or legally authorized guardian.
• Scheduled for congenital cardiac bypass surgery.

You may not qualify if…

• Subjects will not be eligible to participate in the study if any of the following exclusion criteria apply:
• History or a family (parent or sibling) history of malignant hyperthermia.
• Known significant hepatic disorders determined by medical history, medical record documentation, physical examination, or laboratory tests obtained during the routine preoperative cardiac surgery evaluation or cardiology visit (International Normalized Ratio (INR)>1.5).
• Emergency Cardiac Surgery.
• History of chronic nausea and/or vomiting.
• Currently receiving inotropic agents or using a pacemaker.
• Prexisting long QTc interval of greater than 460ms determined by medical history, medical record documentation, or electrocardiogram obtained during the routine preoperative cardiac surgery evaluation.
• History of documented pulmonary hypertension, respiratory dysfunction, or requirement of supplemental oxygen therapy.
• History of opioid abuse, addiction, or tolerance.
• Obesity defined as a body weight greater than 130% of the ideal weight.
• Participation in another clinical trial or any study that may interfere with participation in this trial.
• History of allergic reaction to methadone or fentanyl.

Where it is running

• Children's National Health System — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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