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A Comparison of the Sedation During Endoscopy in Children

NCT02732132 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2016-04-11

No results posted yet for this study

Summary

The primary aim of this study was to investigate the efficiency and safety of midazolam plus ketamine versus fentanyl plus propofol administered to children undergoing UGE and to determine the most appropriate sedation protocol.

Conditions

  • Failed Moderate Sedation During Procedure

Interventions

DRUG

Ketamine and Midazolam

This group was injected intravenous midazolam 0.1 mg/kg (maximum 4 mg), two minutes later, ketamine 1 mg/kg was given intravenously before the start of endoscopy.

DRUG

Propofol and Fentanyl

This group was injected intravenous fentanyl 1 mcg/kg, and two minutes later, propofol 1 mg/kg was given intravenously before the start of endoscopy.

Sponsors & Collaborators

  • Kanuni Sultan Suleyman Training and Research Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-07-31
Completion
2015-09-30

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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 NCT02732132 on ClinicalTrials.gov