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Intranasal Ketamine and Midazolam Mixture for Procedural Sedation in Children With Mental Disabilities:

NCT03860831 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-03-08

No results posted yet for this study

Summary

Ketamine and Midazolam are well known sedative drugs that can be given through different routes such as intravenous, intramuscular, oral, rectal and intranasal route. Anesthetic staff usually prefer intravenous route but sometimes inserting venous access is difficult in uncooperative mentally disabled children. Intranasal ketamine+Midazolam can be a needless effective alternative in these vulnerable patients

Conditions

  • Procedural Sedation

Interventions

DRUG

Ketamine + midazolam

Group IN received intranasal midazolam (0.2 mg/kg) +ketamine (5mg/kg). Group IM received intramuscular midazolam (0.2 mg/kg) +ketamine (5mg/kg) in the gluteal region.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-03-06
Primary Completion
2019-06-30
Completion
2019-07-31

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 NCT03860831 on ClinicalTrials.gov