drugset / Trial / NCT04825704

Bupivacaine in Tonsillectomy

NCT04825704

Phase 3 Completed 84 enrolled Nordland Hospital
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A placebo-controlled and double-blind study is planned according to current legislation and ICH GCP guidelines with 80 patients at Nordland Hospital, Bodø. Fifty percent are randomized to receive bupivacaine 5 mg / ml on the gauze swabs used to stop the bleeding after tonsillectomy, and 50% receive 0.9% sodium chloride. Pain at rest and pain when swallowing according to numerical rating scale (0-10), as well as the presence of the following symptoms (yes / no): nausea, vomiting, food intake, bleeding, fever, need for extra painkillers in the form of morphine or similar will be registered 1, 2, 3, 4, 5, 6 hours and 1, 2 4 and 6 days after the operation. Differences are analyzed with "mixed models" statistics and the results will be published in a peer-based journal.

Timeline

Start
2021-10-27
Primary completion
2023-06-27
Completion
2023-06-27

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 5 mg/ml Topical

Indications

No indication recorded.