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Studies

Interventional Recruiting Phase 3

NCT06122948 on ClinicalTrials.gov

Effect of Intranasal Midazolam Versus Ketamine Midazolam Combination as a Premedication on the Occurrence of Postoperative Respiratory Adverse Events

Official title: Effect of Intranasal Midazolam Versus Ketamine Midazolam Combination as a Premedication in Children Undergoing Tonsillectomy and Adenoidectomy on the Occurrence of Postoperative Respiratory Adverse Events: a Double-blind, Randomized Controlled Trial

  • Sponsor: Kasr Al-Aini Hospital
  • Enrollment: 200 (Estimated)
  • Study start: 2023-09-10 (Actual)
  • Primary completion: 2024-09-01 (Estimated)
  • Study completion: 2024-09-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Children will be randomly assigned to 2 groups: the midazolam group will receive intranasal midazolam (0.1 mg/kg), and the midazolam ketamine group will receive intranasal midazolam (0.1mg/kg) and ketamine (3mg/kg) for premedication
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Prevention

Brief Summary

The aim of this study is to investigate the effect of addition of intranasal ketamine to midazolam compared to midazolam alone as a premedication on the occurrence of PRAEs

Conditions

  • Tonsillectomy
  • Adenoidectomy
  • Drug-Related Side Effects and Adverse Reaction

Intervention / Treatment

  • Drug: The midazolam group
  • Drug: The midazolam ketamine group

Primary Outcome Measures

  • The incidence of any perioperative respiratory adverse events (PRAEs) (8 hours)
    the incidence of any PRAEs (Perioperative respiratory adverse events (PRAEs) which are manifested as minor (oxygen desaturation (SaO2 less than 95% for 10 seconds) or coughing) and major as (bronchospasm, laryngospasm, airway obstruction, stridor or hypoxia (oxygen desaturation less than 90%)) among midazolam versus midazolam ketamine groups.

Countries

Egypt

Locations and Investigators

  • Cairo university hospitals, kasralainy, Cairo, Egypt (Recruiting)
    • khaled sarhan, MD