Sedation During Pediatric Diagnostic Gastrointestinal Endoscopy Gastrointestinal Endoscopy

NCT ID: NCT03235609

Last Updated: 2017-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-16

Study Completion Date

2018-08-15

Brief Summary

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comparison between propofol-fentanyl and propofol-ketamine for sedation in pediatric diagnostic gastrointestinal endoscopy.

Detailed Description

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It is a prospective double blinded controlled study that will be carried out on 60 pediatric patients undergoing GIT endoscopy; they will be divided into two groups of 30 patients each:- Group I (PF): will receive 0.5 µg/ kg fentanyl + 2 mg/ kg propofol IV. Group II (KF): will receive Ketofol (1 ketamine: 4 propofol) 0.5 mg/kg ketamine + 2 mg/kg propofol IV.

Conditions

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Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
double blind

Study Groups

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Fentanyl

Group I (FP): will receive 0.5 µg/ kg fentanyl + 2 mg/ kg propofol IV.

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

fentanyl used with propofol for sedation

Ketamine

Group II (KP): will receive 0.5 mg/kg ketamine + 2 mg/kg propofol IV.

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

ketamine used with propofol for sedation

Interventions

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Fentanyl

fentanyl used with propofol for sedation

Intervention Type DRUG

Ketamine

ketamine used with propofol for sedation

Intervention Type DRUG

Other Intervention Names

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Fentanyl Citrate katalar

Eligibility Criteria

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Inclusion Criteria

* Pediatric patients undergoing diagnostic GIT endoscopy
* ASA I-II

Exclusion Criteria

* Emergency endoscopy
* Respiratory infection and hyperactive airways
* History of serious adverse effects related to anesthetics (e.g. allergic reactions), a family history of reactions to the study drugs
* Morbid obesity, and neuropsychiatric disorders
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed galal aly

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mohamed Aly

Role: CONTACT

00201062011126

References

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Michaud L; Francophone Pediatric Hepatology, Gastroenterology, and Nutrition Group. Sedation for diagnostic upper gastrointestinal endoscopy: a survey of the Francophone Pediatric Hepatology, Gastroenterology, and Nutrition Group. Endoscopy. 2005 Feb;37(2):167-70. doi: 10.1055/s-2004-826144.

Reference Type BACKGROUND
PMID: 15692933 (View on PubMed)

Other Identifiers

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17100212

Identifier Type: -

Identifier Source: org_study_id

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