Back to resultsComparison Between Oral Melatonin and Hydroxyzine in Pediatric Patients Undergoing Adenotonsillectomy
Primary Purpose
Effect of Drug, Anxiety
Status
Recruiting
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Melatonin 3 MG
Hydroxyzine Pill
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Effect of Drug focused on measuring Melatonin, Hydroxyzine, Preoperative Anxiety, Pediatric, Adenotonsillectomy
Eligibility Criteria
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 -
Sites / Locations
- Sarah OmarRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Melatonin
Hydroxyzine
placebo
Arm Description
Preoperative oral melatonin 0.1mg/ kg in 10ml apple juice one hour before induction of anesthesia
Preoperative oral hydroxyzine 1mg/ kg in 10ml apple juice one hour before induction of anesthesia
10ml apple juice one hour before induction of anesthesia
Outcomes
Primary Outcome Measures
Ease of parenteral separation.
Recorded as excellent, good, fair, or poor when the child is separated from the parent
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
Secondary Outcome Measures
Assessment of postoperative pain
Face, Leg, Activity, Cry, and Consolability (FLACC) Scale from 0 to 10, the lower score is better
First analgesic request
Paracetamol
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05680584
Brief Title
Comparison Between Oral Melatonin and Hydroxyzine in Pediatric Patients Undergoing Adenotonsillectomy
Official Title
Comparison Between the Effect of Oral Melatonin and Hydroxyzine for Preventing Preoperative Anxiety in Pediatric Patients Undergoing Adenotonsillectomy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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:
Ease of parenteral separation.
The compliance to anesthesia induction in pediatric patients.
The secondary outcomes:
Assessment of postoperative pain.
Time to first analgesic request.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effect of Drug, Anxiety
Keywords
Melatonin, Hydroxyzine, Preoperative Anxiety, Pediatric, Adenotonsillectomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Three study groups
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Melatonin
Arm Type
Active Comparator
Arm Description
Preoperative oral melatonin 0.1mg/ kg in 10ml apple juice one hour before induction of anesthesia
Arm Title
Hydroxyzine
Arm Type
Active Comparator
Arm Description
Preoperative oral hydroxyzine 1mg/ kg in 10ml apple juice one hour before induction of anesthesia
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
10ml apple juice one hour before induction of anesthesia
Intervention Type
Drug
Intervention Name(s)
Melatonin 3 MG
Other Intervention Name(s)
Melatonin
Intervention Description
0.1 mg/ kg melatonin in 10 ml apple juice 1 hour before induction of anesthesia
Intervention Type
Drug
Intervention Name(s)
Hydroxyzine Pill
Other Intervention Name(s)
Atarax 10mg
Intervention Description
1 mg/ kg hydroxyzine in 10 ml apple juice 1 hour before induction of anesthesia
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
10 ml apple juice 1 hour before induction of anesthesia
Primary Outcome Measure Information:
Title
Ease of parenteral separation.
Description
Recorded as excellent, good, fair, or poor when the child is separated from the parent
Time Frame
20-30 minutes after administration
Title
The compliance to anesthesia induction in pediatric patients.
Description
Assessed by a modified Yale preoperative anxiety scale, the range is from 5 to 22, the lower score is better
Time Frame
one hour after administration
Secondary Outcome Measure Information:
Title
Assessment of postoperative pain
Description
Face, Leg, Activity, Cry, and Consolability (FLACC) Scale from 0 to 10, the lower score is better
Time Frame
immediately before and at induction procedure
Title
First analgesic request
Description
Paracetamol
Time Frame
Three hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Omar, M.D.
Phone
+20100537617
Email
sara.mohamed@mu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Hanafy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Omar
Organizational Affiliation
Minia University
Official's Role
Study Director
Facility Information:
Facility Name
Sarah Omar
City
Al Minyā
ZIP/Postal Code
61111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Omar
Phone
+20100537617
Email
sara.mohamed@mu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
May share when the study is completed
Learn more about this trial
Comparison Between Oral Melatonin and Hydroxyzine in Pediatric Patients Undergoing Adenotonsillectomy
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