drugset / Trial / NCT07072117

Intranasal Dexmedetomidine, Ketamine or Midazolam for Anxiety and Respiratory Complications in Children

NCT07072117

Completed 148 enrolled Zagazig University
RandomizedParallel-groupTriple-blindPrevention

Summary

This study is being done to find out which of three medications-dexmedetomidine, ketamine, or midazolam-is best at reducing anxiety and breathing problems in children having surgery to remove their tonsils and adenoids. These medicines will be given as nose drops before anesthesia. Anxiety before surgery can cause stress and lead to problems like trouble breathing during or after surgery. The study will include 148 children aged 4 to 8 years. Each child will get one of the three medicines or a placebo (saline). Researchers will observe the children for signs of anxiety before surgery and for breathing problems, such as laryngospasm, after they wake up. The goal is to find the safest and most effective medicine to help children feel calmer and breathe safely during surgery.

Timeline

Start
2023-02-20
Primary completion
2023-08-20
Completion
2023-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 2 ug/kg Intranasal
Subject Ketamine Small molecule 2 mg/kg Intranasal
Subject Midazolam Small molecule 0.1 mg/kg Intranasal

Indications

No indication recorded.