Comparing Melatonin and Hydroxyzine for Anxiety in Kids Before Surgery
Comparison Between the Effect of Oral Melatonin and Hydroxyzine for Preventing Preoperative Anxiety in Pediatric Patients Undergoing Adenotonsillectomy
This study is testing whether melatonin or hydroxyzine can help reduce anxiety in kids aged 3 to 10 before they have surgery to remove their tonsils and adenoids.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 3 Years to 10 Years |
| Sex | All |
| Sponsor | Minia University Academic / other |
| Locations | 1 site (Al Minyā) |
| Trial ID | NCT05680584 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of oral melatonin and hydroxyzine in reducing preoperative anxiety in pediatric patients aged 3 to 10 years who are scheduled for adenotonsillectomy. The primary outcomes include the ease of separation from parents and compliance with anesthesia induction, while secondary outcomes assess postoperative pain and the time to first analgesic request. Participants will receive either melatonin, hydroxyzine, or a placebo to evaluate the best approach for managing anxiety in this surgical context.
Who should consider this trial
Good fit: Ideal candidates are healthy children aged 3 to 10 years scheduled for adenotonsillectomy.
Not a fit: Patients with chronic illnesses, developmental delays, or specific allergies to the study medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective method for managing preoperative anxiety in children undergoing surgery.
How similar studies have performed: Other studies have shown promising results in using melatonin for preoperative anxiety, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ASA: class l 2. Sex: male and female 3. Age: from 3 to 10 years old 4. Children scheduled for adenotonsillectomy Exclusion Criteria: 1. All children with a history of chronic illness, or developmental delay were excluded from the study 2. History of an autoimmune disease 3. Concurrent use of immunosuppressive treatment 4. Sleep disturbances, speech or communication problems 5. allergic to hydroxyzine, cetirizine, or other derivatives of piperazine, aminophylline, and ethylenediamine. 6. hydroxyzine is contraindicated in patients with acute porphyria -
Where this trial is running
Al Minyā
- Sarah Omar — Al Minyā, Egypt (Recruiting)
Study contacts
- Study coordinator: Sarah Omar, M.D.
- Email: sara.mohamed@mu.edu.eg
- Phone: +20100537617
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.