Effect of Drug, Anxiety
Conditions
Keywords
Melatonin, Hydroxyzine, Preoperative Anxiety, Pediatric, Adenotonsillectomy
Brief summary
Comparison between the effect of oral Melatonin and Hydroxyzine for Preventing Preoperative Anxiety in pediatric Patients Undergoing Adenotonsillectomy
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: 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.
Interventions
DRUGMelatonin 3 MG
0.1 mg/ kg melatonin in 10 ml apple juice 1 hour before induction of anesthesia
DRUGHydroxyzine Pill
1 mg/ kg hydroxyzine in 10 ml apple juice 1 hour before induction of anesthesia
OTHERPlacebo
10 ml apple juice 1 hour before induction of anesthesia
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Three study groups
Eligibility
Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Contacts
Primary ContactSarah Omar, M.D.
Backup ContactHanafy
Outcome results
None listed