Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-4
SponsorDuke University
About this trial
The purpose of this study is to compare the use of short acting opioids (fentanyl/hydromorphone) with long acting opioids (methadone) for pain control following cleft palate surgery in infants and young children.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 6 months to 4 years of age
Primary cleft palate repair
Signed informed consent by parent or legal guardian
Disqualifiers
History of chronic kidney or liver disease
Planned admission to the Pediatric Intensive Care Unit (PICU)
Additional procedures under general anesthesia for which opioids would be prescribed
Any patient ineligible for study participation at the discretion of the investigators
Trial design
Design model
Parallel
Treatments tested in this trial
Methadone hydrochloride
DrugInitial dosing 0.2mg/kg, potential to escalate to 0.25mg/kg following interim analysis
Fentanyl/Hydromorphone
DrugPer routine care
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: MethadoneActive comparator 1 intervention
Group B: Fentanyl/HydromorphoneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Total amount of opioids medication administered
Post-PACU in-hospital opioid use in oral morphine milligram equivalents (OMEs) per kilogram through POD1
Time frame
From PACU discharge through postoperative day 1 (POD1)Secondary outcomes
1
Total amount of opioid medications administered
Total (post-PACU in-hospital and post-discharge) opioids used (number of daily doses and OME/kg)
Time frame
Up to 7 days after surgery2
Postanesthesia Care Unit (PACU) opioid medication administration
Binary (yes/no) need for opioid administration in the PACU
Time frame
Up to 6 hours after surgery3
Area under the curve (AUC) pain trajectories
In-hospital AUC pain trajectories calculated from pain intensity scores on the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale. The FLACC pain scale has a range of 0 to 10, where 0=no pain and 10=worst possible pain.
Time frame
Through hospital discharge (up to 4 days)4
Average daily pain intensity
Average daily pain scores using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale. The FLACC pain scale has a range of 0 to 10, where 0=no pain and 10=worst possible pain.
Time frame
Up to 7 days after surgerySponsors and contacts
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Source ClinicalTrials.gov