drugset / Trial / NCT02355678

Dexamethasone Versus Local Infiltration Technique for Tonsillectomy in Children

NCT02355678 ↗

Completed 129 enrolled Makassed General Hospital
RandomizedParallel-groupTriple-blindTreatment

Summary

Tonsillectomy is one of the most frequent surgical operations performed in children \[1-4\]. It is usually associated with postoperative nausea and vomiting (PONV) with an incidence ranging from 23% to 73% \[2\]. Dexamethasone has been shown to be effective in reducing PONV after tonsillectomy using standardized anesthetic technique \[2, 5-7\]. Previous studies utilizing a different technique, the pre-incision infiltration of local anesthesia, had shown to decrease post-tonsillectomy pain, reduce analgesic consumption and provide a rapid return to normal activity \[8, 9\]. Given the effectiveness of dexamethasone and the pre-incision infiltration anesthetic technique, it would be beneficial to compare the effect of each on PONV.

Timeline

Start
2015-01
Primary completion
2015-08
Completion
2015-08

Outcome

Missed primary endpoint

paper After 24 h, the incidence of PONV was significantly higher in group I compared to group II (26.6% vs. 9.2% respectively, p-value = 0.019). PMID 28012528 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified — Other
Subject Clonidine Other / unclassified — Other
Subject Dexamethasone Small molecule 0.5 mg/kg Intravenous
Subject Fentanyl Other / unclassified — Intravenous
Subject Lidocaine Other / unclassified — Other
Background Acetaminophen Small molecule 350 mg Rectal
Background Atracurium Small molecule 0.5 mg/kg Intravenous
Background Nitrous Oxide Other / unclassified 70 % —
Background Oxygen Other / unclassified 30 % —
Background Propacetamol Small molecule 15 mg/kg Intravenous
Background Propofol Small molecule 2.5 mg/kg Intravenous
Background Sevoflurane Other / unclassified — —
Background Tramadol Other / unclassified — —

Indications

No indication recorded.