Methadone Pharmacokinetics in Cardiac Surgery
ConditionPostoperative Pain Management
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorWake Forest University Health Sciences
About this trial
Cardiac surgery frequently leads to significant postoperative pain, with multiple different drug regimens being utilized (both opioid and non-opioid) in an attempt to alleviate this surgical pain. Methadone is currently one of the drugs that is being utilized to help control the pain. It can be given during and/or after surgery. This study hopes to identify the optimal dose of methadone to use to treat this surgical pain.
Eligibility criteria
Qualifiers
Elective cardiac surgery requiring median sternotomy and cardiopulmonary bypass (CABG, valve, combined CABG/valve surgeries)
Anticipated extubation within 12 hours postoperatively
No prior opioid use within 30 days of surgery
Ability to provide informed consent
Disqualifiers
Severe liver or kidney dysfunction (Child-Pugh class B/C, eGFR <30 mL/min/1.73m², creatinine >2 mg/dL, dialysis)
Allergy to methadone or fentanyl
Use of CYP3A4 inducers (rifampin, phenytoin, carbamazepine), CYP3A4 inhibitors (ketoconazole, erythromycin, clarithromycin, itraconazole), SSRIs (fluoxetine, sertraline, paroxetine, citalopram, escitalopram, fluvoxamine)
Body mass index >40 kg/m²
Trial design
Treatments tested in this trial
- Single dose of methadone
- Split dose of methadone
- Balanced split dose of methadone
Treatment groups
69 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov