Comparison Between Oral Melatonin and Hydroxyzine in Pediatric Patients Undergoing Adenotonsillectomy
Study Details
Study Description
Brief Summary
Comparison between the effect of oral Melatonin and Hydroxyzine for Preventing Preoperative Anxiety in pediatric Patients Undergoing Adenotonsillectomy
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Detailed 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:
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Ease of parenteral separation.
-
The compliance to anesthesia induction in pediatric patients.
The secondary outcomes:
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Assessment of postoperative pain.
-
Time to first analgesic request.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Melatonin Preoperative oral melatonin 0.1mg/ kg in 10ml apple juice one hour before induction of anesthesia |
Drug: Melatonin 3 MG
0.1 mg/ kg melatonin in 10 ml apple juice 1 hour before induction of anesthesia
Other Names:
|
Active Comparator: Hydroxyzine Preoperative oral hydroxyzine 1mg/ kg in 10ml apple juice one hour before induction of anesthesia |
Drug: Hydroxyzine Pill
1 mg/ kg hydroxyzine in 10 ml apple juice 1 hour before induction of anesthesia
Other Names:
|
Placebo Comparator: placebo 10ml apple juice one hour before induction of anesthesia |
Other: Placebo
10 ml apple juice 1 hour before induction of anesthesia
|
Outcome Measures
Primary Outcome Measures
- Ease of parenteral separation. [20-30 minutes after administration]
Recorded as excellent, good, fair, or poor when the child is separated from the parent
- The compliance to anesthesia induction in pediatric patients. [one hour after administration]
Assessed by a modified Yale preoperative anxiety scale, the range is from 5 to 22, the lower score is better
Secondary Outcome Measures
- Assessment of postoperative pain [immediately before and at induction procedure]
Face, Leg, Activity, Cry, and Consolability (FLACC) Scale from 0 to 10, the lower score is better
- First analgesic request [Three hours postoperative]
Paracetamol
Eligibility Criteria
Criteria
Inclusion Criteria:
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ASA: class l
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Sex: male and female
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Age: from 3 to 10 years old
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Children scheduled for adenotonsillectomy
Exclusion Criteria:
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All children with a history of chronic illness, or developmental delay were excluded from the study
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History of an autoimmune disease
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Concurrent use of immunosuppressive treatment
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Sleep disturbances, speech or communication problems
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allergic to hydroxyzine, cetirizine, or other derivatives of piperazine, aminophylline, and ethylenediamine.
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hydroxyzine is contraindicated in patients with acute porphyria
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Sarah Omar | Al Minyā | Egypt | 61111 |
Sponsors and Collaborators
- Minia University
Investigators
- Study Director: Sarah Omar, Minia University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 505/2022