drugset / Trial / NCT03950817

Nebulized Sub-dissociative Dose Ketamine at Three Different Dosing Regimens for Treating Acute Pain in the Pediatric ED

NCT03950817 ↗

Phase 4 Completed 80 enrolled Antonios Likourezos
RandomizedParallel-groupQuadruple-blindTreatment

Summary

In the situation when intravenous access is not readily available or unobtainable, sub-dissociative dose ketamine can be administered via intranasal route (IN). The data supporting intranasal route in pediatric patients is somewhat conflicting with regards to the optimum intranasal dose (range 0.75-1 mg/kg) and frequencies of administration. Hence, another non-invasive route such as nebulization via Breath-Actuated Nebulizer which allows a controlled patient-initiated delivery of analgesics in titratable fashion might be considered in the ED. Administration of fentanyl via BAN for pediatric patients presenting to the ED with acute traumatic musculo-skeletal injuries was found to be safe and effective and comparable to intravenous fentanyl and intravenous morphine. Nebulized administration of ketamine however, has only been studied in the areas of acute postoperative pain management, cancer palliation, and status asthmaticus therapy (ref). To our knowledge, there are no prospective randomized trials that evaluated a role of nebulized SDK role in managing a variety of acute and chronic painful conditions in the ED.

Timeline

Start
2019-05-13
Primary completion
2024-09-24
Completion
2024-09-24

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ketamine Small molecule 0.75 mg/kg Other
Comparator Ketamine Small molecule 1 mg/kg Other
Comparator Ketamine Small molecule 1.5 mg/kg Other

Indications

No indication recorded.