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

Tanta University

Status: Completed

Conditions: Pediatric; Anesthesia

Treatments: Drug: Oral Midazolam; Drug: Oral ketamin; Drug: Oral dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06879496

36264PR1102/2/25

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 3 to 7 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Group K

Active Comparator group

Description:

Patients will receive orally ketamin 6 mg/kg.

Treatment:

Drug: Oral ketamin

Group D

Active Comparator group

Description:

Patients will receive orally dexmedetomidine 4 mcg kg -1

Treatment:

Drug: Oral dexmedetomidine

Group M

Active Comparator group

Description:

Patients will receive orally midazolam 0.5 mg kg -1.

Treatment:

Drug: Oral Midazolam