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Comparison Between Oral Melatonin and Hydroxyzine in Pediatric Patients Undergoing Adenotonsillectomy

Comparison Between Oral Melatonin and Hydroxyzine in Pediatric Patients Undergoing Adenotonsillectomy

Not Recruiting
3-10 years
All
Phase 1

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Overview

Comparison between the effect of oral Melatonin and Hydroxyzine for Preventing Preoperative Anxiety in pediatric Patients Undergoing Adenotonsillectomy

Description

The aim of the study is to compare the effectiveness of preoperative oral melatonin and hydroxyzine on preoperative anxiety in pediatric patients undergoing adenotonsillectomy.

The primary outcomes:

  1. Ease of parenteral separation.
  2. The compliance to anesthesia induction in pediatric patients.

The secondary outcomes:

  1. Assessment of postoperative pain.
  2. Time to first analgesic request.

Eligibility

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

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Study details
    Effect of Drug
    Anxiety

NCT05680584

Minia University

30 January 2026

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