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

NCT06122948 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-10-15

No results posted yet for this study

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

Interventions

DRUG

The midazolam group

The midazolam group will receive intranasal midazolam (0.1 mg/kg)

DRUG

The midazolam ketamine group

the midazolam ketamine group will receive intranasal midazolam (0.1mg/kg) and ketamine (3mg/kg)

Sponsors & Collaborators

  • Kasr El Aini Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-04
Primary Completion
2024-10-10
Completion
2024-10-10

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06122948 on ClinicalTrials.gov