Comparison Between Oral Melatonin and Hydroxyzine in Pediatric Patients Undergoing Adenotonsillectomy

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

Detailed Description
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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: Ease of parenteral separation. The compliance to anesthesia induction in pediatric patients. The secondary outcomes: Assessment of postoperative pain. Time to first analgesic request.

Official Title
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Comparison Between the Effect of Oral Melatonin and Hydroxyzine for Preventing Preoperative Anxiety in Pediatric Patients Undergoing Adenotonsillectomy

Conditions
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Effect of Drug, Anxiety

Intervention / Treatment
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* Drug: Melatonin 3 MG
* Drug: Hydroxyzine Pill
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA: class l Sex: male and female Age: from 3 to 10 years old Children scheduled for adenotonsillectomy Exclusion Criteria: All children with a history of chronic illness, or developmental delay were excluded from the study History of an autoimmune disease Concurrent use of immunosuppressive treatment Sleep disturbances, speech or communication problems allergic to hydroxyzine, cetirizine, or other derivatives of piperazine, aminophylline, and ethylenediamine. hydroxyzine is contraindicated in patients with acute porphyria -

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three study groups
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Melatonin<br>Preoperative oral melatonin 0.1mg/ kg in 10ml apple juice one hour before induction of anesthesia | Drug: Melatonin 3 MG<br>* 0.1 mg/ kg melatonin in 10 ml apple juice 1 hour before induction of anesthesia<br>* Other names: Melatonin;|
| Active Comparator: Hydroxyzine<br>Preoperative oral hydroxyzine 1mg/ kg in 10ml apple juice one hour before induction of anesthesia | Drug: Hydroxyzine Pill<br>* 1 mg/ kg hydroxyzine in 10 ml apple juice 1 hour before induction of anesthesia<br>* Other names: Atarax 10mg;|
| Placebo Comparator: placebo<br>10ml apple juice one hour before induction of anesthesia | Other: Placebo<br>* 10 ml apple juice 1 hour before induction of anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of parenteral separation. | Recorded as excellent, good, fair, or poor when the child is separated from the parent | 20-30 minutes after administration | 
| The compliance to anesthesia induction in pediatric patients. | Assessed by a modified Yale preoperative anxiety scale, the range is from 5 to 22, the lower score is better | one hour after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of postoperative pain | Face, Leg, Activity, Cry, and Consolability (FLACC) Scale from 0 to 10, the lower score is better | immediately before and at induction procedure | 
| First analgesic request | Paracetamol | Three hours postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melatonin, Hydroxyzine, Preoperative Anxiety, Pediatric, Adenotonsillectomy