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.

March 7, 2026 updated by: Omnia Yahia El Sayed Kamel, Cairo University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Surgery and anesthesia induce considerable emotional stress on parents and children. Children are particularly vulnerable to this surgical stress response since their limited energy reserves; larger brain mass, compared to body size; and glucose requirements. Thus, controlling and preventing perioperative stress responses is crucial in modern pediatric anesthesia. Many postoperative negative behavioral changes such as nightmares and separation anxiety. In addition to these behavioral manifestations, preoperative anxiety activates the human stress response. So, a multimodal approach consisting of sedative drugs, parental presence, play therapy, familiar environment and effective pain therapy is necessary to reduce preoperative anxiety. The benzodiazepine midazolam has traditionally been used to relieve preoperative stress and provide sedation in pediatric patients; however, in higher doses, it has an increased risk of respiratory depression.

Alternatively, premedication with clonidine, although less popular, has been shown to reliably produce preoperative sedation and anxiolysis in children; furthermore, it has analgesic properties, decreases volatile anesthetic and opioids requirements and improves perioperative hemodynamic stability.

Clonidine, a selective centrally acting partial a2-agonist, traditionally, it has been used as an antihypertensive agent since the late sixties. Its primary effect is a sympatholytic drug, and it reduces peripheral norepinephrine release by stimulation of the prejunctional inhibitory alpha-2 adrenoceptors. Further uses based on its sedative, anxiolytic and analgesic properties are being developed.

Ketamine is a sedative premedication that is commonly used in children. It is an N-methyl D-aspartate (NMDA) receptor antagonist that produces sedation, immobilization, and analgesia without causing respiratory depression. It has been used in a variety of ways, most recently intranasal in children To the best of our knowledge, no previous studies compared between oral ketamine and oral clonidine as premedication in children undergoing elective lower abdominal day-case surgery.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Giza Governorate
      • Cairo, Giza Governorate, Egypt
        • Recruiting
        • Faculty of medicine, Cairo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group Oral Clonidine (OC)
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)
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.
Other Names:
  • Oral Ketamine (OK)
Active Comparator: Group Oral Ketamine (OK)
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)
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.
Other Names:
  • Oral Ketamine (OK)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sedation level
Time Frame: 60 minutes after administration of the drug (at time of separation from the parents).
using Ramsey sedation scale (RSS)
60 minutes after administration of the drug (at time of separation from the parents).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fentanyl administration.
Time Frame: at 10, 20, 30, 40, 50 minutes until the end of the surgery
Need and timing of fentanyl administration intraoperatively.
at 10, 20, 30, 40, 50 minutes until the end of the surgery
Postoperative emergence delirium
Time Frame: Postoperative at 15, 30, 45 and 60 minutes
assessed at PACU every 15 minutes for 1 hour using pediatric anesthesia emergency and delirium scale (PAED).
Postoperative at 15, 30, 45 and 60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Nevine M Gouda, Professor, Cairo University
  • Study Director: Sherif M Soaida, Assistant Professor, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

May 16, 2025

First Submitted That Met QC Criteria

March 7, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 7, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pediatric Sedation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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