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Sedation During Pediatric Diagnostic Gastrointestinal Endoscopy Gastrointestinal Endoscopy

A

Assiut University

Status

Unknown

Conditions

Sedation

Treatments

Drug: Ketamine
Drug: Fentanyl

Study type

Interventional

Funder types

Other

Identifiers

NCT03235609
17100212

Details and patient eligibility

About

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

Full description

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.

Enrollment

60 estimated patients

Sex

All

Ages

6 to 16 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

Fentanyl
Active Comparator group
Description:
Group I (FP): will receive 0.5 µg/ kg fentanyl + 2 mg/ kg propofol IV.
Treatment:
Drug: Fentanyl
Ketamine
Active Comparator group
Description:
Group II (KP): will receive 0.5 mg/kg ketamine + 2 mg/kg propofol IV.
Treatment:
Drug: Ketamine

Trial contacts and locations

0

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Central trial contact

Mohamed Aly

Data sourced from clinicaltrials.gov

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