drugset / Trial / NCT02987985
Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing Tonsillectomy
RandomizedParallel-groupTriple-blindPrevention
Summary
The objective of this trial is to determine whether an opioid-free general anesthetic (OFA) technique utilizing ketamine, dexmedetomidine, lidocaine, and gabapentin can help reduce postoperative respiratory depression in the post-anesthesia care unit and ward in children with sleep-disordered breathing undergoing tonsillectomy when compared with traditional opioid-containing techniques. It is expected that this OFA regimen will have a measurable reduction on postoperative respiratory depression in children with sleep-disordered breathing.
Timeline
- Start
- 2017-10-15
- Primary completion
- 2019-09-20
- Completion
- 2020-12-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fentanyl | Other / unclassified | 0.5 ug/kg | — |
| Subject | Gabapentin | Small molecule | 10 mg/kg | — |
| Subject | Ketamine | Small molecule | 0.5 mg/kg | — |
| Subject | Lidocaine | Other / unclassified | 1 mg/kg | — |
| Background | Acetaminophen | Small molecule | 15 mg/kg | — |
| Background | Dexamethasone | Small molecule | 150 ug/kg | — |
| Background | Dexmedetomidine | Other / unclassified | 0.3 ug/kg | — |
| Background | Ondansetron | Other / unclassified | 50 mg/kg | — |
| Background | Sevoflurane | Other / unclassified | — | — |