A Comparison of the Sedation During Endoscopy in Children

NCT02732132 | Completed Phase 4

• 1 other identifier: 2015/18
• Study Type: interventional
• Target: 238
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• the effectiveness of sedation

  the effectiviness of midazolam plus ketamine versus fentanyl plus propofol according to a modified Ramsay sedation score

  six months

Secondary Outcomes (3)

• adverse events that are related to study drugs

  six months

• procedure time

  six months

• recovery time

  six months

Study Arms (2)

Ketamine and Midazolam

ACTIVE COMPARATOR

ketamine 1 mg/kg midazolam 0.1 mg/kg

Drug: Ketamine and Midazolam

Propofol and Fentanyl

EXPERIMENTAL

propofol 1 mg/kg fentanyl 1 mcg/kg

Drug: Propofol and Fentanyl

Interventions

Ketamine and Midazolam DRUG

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.

Also known as: Ketalar (Ketamin, Pfizer) and Dormicum (Midazolam, Roche)

Ketamine and Midazolam

Propofol and Fentanyl DRUG

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.

Also known as: Propofol Lipuro (Propofol, B-Braun) Fentanyl (Fentanyl, J&J)

Propofol and Fentanyl

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All the patients were in ASA (American Society of Anesthesiologists) physical status I or II.

You may not qualify if:

• Patients with respiratory tract infections, glaucoma, psychosis, porphyria, hypertension, metabolic or neurologic diseases, increased intracranial pressure and intracranial mass, and patients known to be allergic to the drugs used were excluded from the study.

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

MeSH Terms

Interventions

Ketamine; Midazolam; Propofol; Fentanyl

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Piperidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: April 8, 2016
• Study Start: January 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 11, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share