Comparison of Oral Dexmedetomidine, Ketamine Versus Midazolam for Premedication in Children Undergoing Injuinal Surgeries

Not Applicable

• Conditions: Anesthesia; Pediatric
• Interventions: Drug: Oral ketamin; Drug: Oral dexmedetomidine; Drug: Oral Midazolam

• Registration Number: NCT06879496
• Lead Sponsor: Tanta University

Brief Summary

The aim of this study is to compare between oral dexmedetomidine, Ketamine or midazolam for premedication in children undergoing inguinal hernia surgeries.

Detailed Description

This randomized, double-blind comparative study will be carried out on 60 children undergoing inguinal hernia surgeries admitted to Tanta University Hospitals over a period from Mars 2025-September 2025.

An informed written consent will be obtained from the parents of these children. Every patient will receive an explanation of the purpose of the study and will have a secret code number.

Research results will be only used for scientific purpose. Any unexpected risk/s appearing during the course of research will be clarified to the participants and to the ethical committee on time.

Randomization and blinding:

Patients who meet the previous criteria will be enrolled in the study. Patients will be randomly classified into three equal groups: 20 patients will be enrolled in each group using computer generated random number in closed sealed, opaque envelopes:

(Group K): Patients will receive orally ketamin 6 mg/kg. (Group D): Patients will receive orally dexmedetomidine 4 mcg kg -1 (Group M): Patients will receive orally midazolam 0.5 mg kg -1. Patients and outcome assessors involved will be blinded to the study allocation and outcomes.

Study protocol:

Before operation, all patients will receive Groups M and D, K will receive an oral administration of 0.2 mg/kg of midazolam (up to a maximum of 15 mg) and 4 µg/kg of dexmedetomidine, 6mg ketamine respectively mixed with apple juice to make a final volume of 3-5 ml, in the preoperative holding area 40 min prior to anesthesia induction.

General anesthesia will be induced. Standard monitoring included electrocardiography (ECG), end-tidal carbon dioxide, arterial oxygen saturation continuously, pulse oximetry, and non-invasive BP every 5 min.

The anesthetic technique will be standardized in all patients. Anesthesia will be induced with sevoflurane 8% in oxygen 100% via a Jackson Rees breathing circuit. An i.v. cannula will be placed after induction of anesthesia. Patients then will receive i.v. propofol 1 mg kg-1 and a laryngeal Mask Airway will be applied.

Anesthesia will be maintained with sevoflurane in a 50% oxygen/air mixture. Spontaneous breathing will be maintained during the procedure. No other sedatives or opioids will be administered during the procedure. At the end of the procedure, the laryngeal mask will be removed, and the child will be transferred to the PACU once the airway will be maintained spontaneously and there will be no hemodynamic instability.

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-10
• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-14
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-19
• Primary Completion: 2025-09-10
• Study Completion: 2025-09-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Children aged between 3-7 years.
• Both sexes.
• American society of anesthesiologists (ASA) physical status (I-II).

Exclusion Criteria

• Parents refusal.
• Patients with known allergy to the study drugs.
• Significant organ dysfunction.
• Cardiac dysrhythmia.
• Use of psychotropic medication, and mental retardation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group K	Oral ketamin	Patients will receive orally ketamin 6 mg/kg.
Group D	Oral dexmedetomidine	Patients will receive orally dexmedetomidine 4 mcg kg -1
Group M	Oral Midazolam	Patients will receive orally midazolam 0.5 mg kg -1.

Primary Outcome Measures

Name	Time	Method
Primary outcome	on arrival in the operating room 30 min after end of study drug administration.	five-point sedation score

Secondary Outcome Measures

Name	Time	Method
Secondary outcome	Till 1 hour after operation	FLACC score Postoperative face, legs, activity, cry, and consolability (FLACC) scale.

Trial Locations

Locations (1)

Mohamed Zakarea Wfa; 🇪🇬 Tanta, Egypt