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Comparison between the effect of oral Melatonin and Hydroxyzine for Preventing Preoperative Anxiety in pediatric Patients Undergoing Adenotonsillectomy
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:
The secondary outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin | Active Comparator | Preoperative oral melatonin 0.1mg/ kg in 10ml apple juice one hour before induction of anesthesia |
|
| Hydroxyzine | Active Comparator | Preoperative oral hydroxyzine 1mg/ kg in 10ml apple juice one hour before induction of anesthesia |
|
| placebo | Placebo Comparator | 10ml apple juice one hour before induction of anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin 3 MG | Drug | 0.1 mg/ kg melatonin in 10 ml apple juice 1 hour before induction of anesthesia |
|
| 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 |
| 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 |
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Inclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Omar, M.D. | Contact | +20100537617 | sara.mohamed@mu.edu.eg | |
| Hanafy | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Sarah Omar | Minia University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarah Omar | Recruiting | Al Minyā | 61111 | Egypt |
May share when the study is completed
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| D006919 | Hydroxyzine |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Three study groups
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| Hydroxyzine Pill | Drug | 1 mg/ kg hydroxyzine in 10 ml apple juice 1 hour before induction of anesthesia |
|
|
| Placebo | Other | 10 ml apple juice 1 hour before induction of anesthesia |
|
Paracetamol
| Three hours postoperative |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |