Oral ketamine versus oral clonidine to calm children before elective lower abdominal day-case surgery
Official title: 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.
Run by Cairo University · NCT07461376 · Data updated 2026-11-12
We will test whether a single dose of oral ketamine or oral clonidine given before elective lower abdominal day-case surgery helps children be calmer and reduces the need for opioid pain medicines.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Years to 12 Years |
| Sex | All |
| Enrollment | 84 (estimated) |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo, Giza Governorate) |
| Status | Recruiting |
| Started | April 15, 2025 |
| Main results expected | June 1, 2026 |
| Study ends | November 1, 2026 |
| Registry record updated | March 10, 2026 |
| Trial ID | NCT07461376 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 3 to 12 years, ASA I–II, scheduled for elective lower abdominal day-case surgery (for example inguinal herniorrhaphy, hypospadias repair, or circumcision) whose parents consent and who have no major cardiac, respiratory, neurologic disorders or drug allergies.
✕Probably not a fit
Children with ASA score > II, significant heart/lung/neurologic disease, known allergy to the study drugs, or those having other types of surgery are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional trial enrolls children aged 3–12 years (ASA I–II) having elective lower abdominal day-case operations and gives one group oral ketamine and the other oral clonidine as premedication. Sedation level is measured before and after surgery and intraoperative opioid consumption is recorded to compare the two drugs. Children with significant cardiac, respiratory, neurologic disease or drug allergies are excluded. The trial is conducted at the Faculty of Medicine, Cairo University and uses standard anesthesia and monitoring protocols.
Why it matters
Potential benefit: If successful, this could identify a premedication that reduces preoperative anxiety and lowers intraoperative opioid requirements for children undergoing these procedures.
How similar studies have gone: Prior pediatric research shows clonidine reliably produces preoperative sedation and can reduce anesthetic and opioid needs while ketamine is established for sedation and analgesia, though direct head-to-head comparisons in this exact setting have been limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Faculty of Medicine, Cairo University
Cairo, Giza Governorate, Egypt Recruiting
Study contacts
- Study coordinator: Omnia Y Kamel, Doctorate degree
- Email: omniayehiakamel90@gmail.com
- Phone: 01270130326
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.