Comparison Between Oral Melatonin and Hydroxyzine in Pediatric Patients Undergoing Adenotonsillectomy

Minia University

Status and phase: Enrolling; Phase 1

Conditions: Anxiety; Effect of Drug

Treatments: Drug: Hydroxyzine Pill; Other: Placebo; Drug: Melatonin 3 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05680584

505/2022

Details and patient eligibility

About

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

Full 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.

Enrollment: 78 estimated patients

Sex: All

Ages: 3 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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78 participants in 3 patient groups, including a placebo group

Melatonin

Active Comparator group

Description:

Preoperative oral melatonin 0.1mg/ kg in 10ml apple juice one hour before induction of anesthesia

Treatment:

Drug: Melatonin 3 MG

Hydroxyzine

Active Comparator group

Description:

Preoperative oral hydroxyzine 1mg/ kg in 10ml apple juice one hour before induction of anesthesia

Treatment:

Drug: Hydroxyzine Pill

placebo

Placebo Comparator group

Description:

10ml apple juice one hour before induction of anesthesia

Treatment:

Other: Placebo