Premedication in Children: a Clinical Trial Comparing Oral Ketamine and Oral Clonidine With Respect to Sedation Level and Opioid Consumption in Pediatrics Undergoing Elective Lower Abdominal Day-case Surgery.

NCT07461376 | Recruiting

• 1 other identifier: Pediatric Sedation
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the work Is to compare between oral ketamine and oral clonidine regarding the level of sedation pre and postoperatively in addition the need of opioids administration intraoperative in children undergoing elective lower abdominal day-case surgery.

Conditions

Pediatric Sedation; Clonidine Sedation; Ketamine Sedation

Outcome Measures

Primary Outcomes (1)

• Sedation level

  using Ramsey sedation scale (RSS)

  60 minutes after administration of the drug (at time of separation from the parents).

Secondary Outcomes (2)

• Fentanyl administration.

  at 10, 20, 30, 40, 50 minutes until the end of the surgery

• Postoperative emergence delirium

  Postoperative at 15, 30, 45 and 60 minutes

Study Arms (2)

Group Oral Clonidine (OC)

ACTIVE COMPARATOR

This group of children will be premedicated with oral clonidine (4 mic/Kg) 60 minutes preoperatively in a sip of water.

Drug: Oral Clonidine (OC)

Group Oral Ketamine (OK)

ACTIVE COMPARATOR

This group of children will be premedicated with oral Ketamine (10 mg/Kg) 60 minutes preoperatively in a sip of water.

Drug: Oral Clonidine (OC)

Interventions

Oral Clonidine (OC) DRUG

compare between oral ketamine and oral clonidine regarding the level of sedation pre and postoperatively in addition the need of opioids administration intraoperative in children undergoing elective lower abdominal day-case surgery.

Also known as: Oral Ketamine (OK)

Group Oral Clonidine (OC); Group Oral Ketamine (OK)

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged between 3 to 12 years old of both sexes undergoing elective lower abdominal day-case surgery such as: oblique inguinal herniorrhaphy, hypospadias correction and circumcision.
• ASA I and II

You may not qualify if:

• Parents refusal.
• ASA risk score \>II
• Heart, lung, neurological, or central nervous system disorders (hypotension, hypovolemia, severe bradyarrhythmia, atrioventricular block II or III, acute cerebrovascular events, impaired consciousness, respiratory disorders with hypoventilation, myasthenia gravis and central sleep apnea syndrome)
• Allergy from the used drugs.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine, Cairo University

Cairo, Giza Governorate, Egypt

RECRUITING

MeSH Terms

Interventions

Clonidine; Ketamine

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Nevine M Gouda, Professor

  Cairo University

  STUDY CHAIR

• Sherif M Soaida, Assistant Professor

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Omnia Y Kamel, Doctorate degree

CONTACT

01270130326; omniayehiakamel90@gmail.com

Ahmed O Mohamed, Master

CONTACT

01014429299; ahmedomoh630@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: ● Patients will be randomized using a computer-generated randomization list. Random group assigned will be enclosed in a sealed envelope to ensure concealment of allocation sequence. The sealed envelope will be opened by an anesthesiologist who will not be involved in the study to prepare the drug solution according to randomization. The anesthesiologist administrating the drug and observing the patient will be blinded to the treatment group.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesiology and surgical ICU and pain management

Model Details: A randomized controlled double blinded study

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: March 10, 2026
• Study Start: April 15, 2025
• Primary Completion: June 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)