drugset / Trial / NCT05506930

ITM vs QL for Pediatric Open Lower Abdominal Procedures

NCT05506930 ↗

Phase 4 Terminated 14 enrolled Medical University of South Carolina
RandomizedParallel-groupSingle-blindTreatment

Summary

Patients between the ages of 12 months and 11 years who are undergoing an open lower abdominal procedure will be randomized to receive intrathecal morphine, or bilateral quadratus lumborum block. The investigators will compare the effect that intrathecal morphine and quadratus lumborum blocks have on the duration of pain control as demonstrated by charted pain scores and morphine equivalents in the first 48 hours. This study will also assess the side effects of each intervention such as nausea and vomiting, and itching.

Timeline

Start
2022-08-17
Primary completion
2024-05-09
Completion
2024-05-10

Outcome

Outcome not reported

Stopped: “The study was stopped early based on the anecdotal evidence from a surgeon who felt one group was experiencing more side effects than the other. Exposing pediatric patients who would be assigned to the inferior arm was difficult to justify ethically.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Morphine Other / unclassified 4 ug/kg Intrathecal
Comparator Morphine Other / unclassified 5 ug/kg Intrathecal
Comparator Ropivacaine Other / unclassified 0.2 % Other