Sedation During Pediatric Diagnostic Gastrointestinal Endoscopy Gastrointestinal Endoscopy

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

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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