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

• Status: Terminated
• Trial end date: 2019-02-07
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Andrew Waberski
• Treatments: Fentanyl; Methadone; Morphine

Criteria

Inclusion Criteria:

1. Age greater than or equal to 2 years and less than 8 years at the time of randomization.

2. Weight greater than 6 kg.

3. American Society of Anesthesiologists (ASA) physical status of ASA I, II, or III (Appendix I).

4. Informed consent to participate from the parent or legally authorized guardian.

5. Scheduled for congenital cardiac bypass surgery.

Exclusion Criteria

Subjects will not be eligible to participate in the study if any of the following exclusion criteria apply:

1. History or a family (parent or sibling) history of malignant hyperthermia.

2. 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).

3. Emergency Cardiac Surgery.

4. History of chronic nausea and/or vomiting.

5. Currently receiving inotropic agents or using a pacemaker.

6. 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.

7. History of documented pulmonary hypertension, respiratory dysfunction, or requirement of supplemental oxygen therapy.

8. History of opioid abuse, addiction, or tolerance.

9. Obesity defined as a body weight greater than 130% of the ideal weight.

10. Participation in another clinical trial or any study that may interfere with participation in this trial.

11. History of allergic reaction to methadone or fentanyl.