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Nebulized Dexmedetomidine VS ODF Melatonin for Peri Operative Anxiety and Emergence Agitation in Pediatric Day Surgery

Primary Purpose

Anxiety Acute, Emergence Agitation

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
Melatonin
Placebo
Sponsored by
nada moahmed aboelrouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety Acute

Eligibility Criteria

2 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients of American Society of Anesthesiologists (ASA) physical status I & II both genders, ≥ 2 to 10 years, scheduled for elective day case surgery under general anesthesia Exclusion Criteria: parents' refusal for participation in the study ASA III and VI patients with history of chronic illness runny nose or upper respiratory tract infection Emergency surgeries with hemodynamic instability history of allergic reaction to dexmedetomidine or melatonin History of prematurity developmental delay central nervous system disorder, mental retardation, neurological or psychiatric illness that may be associated with anxiety and agitation (cerebral palsy, seizure, separation anxiety disorder, ADHD etc.). treatment with anticonvulsants and sedatives

Sites / Locations

  • Ain shams university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

group D

group M

group C

Arm Description

will receive placebo ODF and nebulized dexmedetomidine (Precedex™ rxlist)

will receive placebo nebulizer and ODF melatonin (metacyst ™ nerhadou)

will receive placebo ODF and placebo 0.9% normal saline nebulizer

Outcomes

Primary Outcome Measures

perioperative anxiety
perioperative anxiety will be measured by using Parental separation anxiety scale (PSAS) will be calculated according to the following: Behavior of the child during separation from parents will be Excellent if the Patient unafraid, cooperative, or asleep will be given the score of (1) Behavior of the child during separation from parents will be Good if the patient is Slightly afraid/crying, quiet with reassurance will be given the score (2) Behavior of the child during separation from parents will be Fair if the patient is Moderately afraid and crying not quit with reassurance with the score (3) Behavior of the child during separation from parents will be poor if the patient is Crying, need for restraint with the score (4) the score of (1) means excellent response , score of (2) means good response , score of (3) means fair response and score of (4) means poor response

Secondary Outcome Measures

mask acceptance
calculated according to the mask acceptance scale (MAS) as following : if the Child is calm, cooperative, or asleep the score will be (1) if the child is in Moderate fear of the mask Manageable with reassurance the score will be(2) if the child Cries, combative and needs restraining the score will be (3) score of (1) means excellent response ,score of (2) means fair response and score of (3) means poor response
post anesthesia emergence agitation
will be assessed by using Pediatric Anesthesia Emergence Delirium Scale (PAED) with score 1= calm , 2= not calm but could be easily consoled , 3= moderately agitated or restless and not easily calmed , 4 = combative , excited , thrashing around
pain score
using Face, leg, activity, cry and Consolability score With score of 0 meaning no pain and requires no intervention and score of 10 indicating the worst imaginable pain requiring rescue analgesia

Full Information

First Posted
February 19, 2023
Last Updated
March 2, 2023
Sponsor
nada moahmed aboelrouse
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1. Study Identification

Unique Protocol Identification Number
NCT05766436
Brief Title
Nebulized Dexmedetomidine VS ODF Melatonin for Peri Operative Anxiety and Emergence Agitation in Pediatric Day Surgery
Official Title
Nebulized Dexmedetomidine VS Oro-dispersible Film Melatonin for Peri Operative Anxiety and Emergence Agitation in Pediatric Outpatient Surgeries: A Randomized Controlled Double-blinded Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Anticipated)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
nada moahmed aboelrouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this clinical trial is to compare between the effect of nebulized dexmedetomidine and the effect of oral dispensable film (ODF) melatonin in controlling perioperative anxiety and post operative emergence agitation and their effect on the overall surgical experience.in pediatric patients undergoing day case surgery.
Detailed Description
All patients will be admitted on the day of the surgery and will be instructed to fast 6 hours before surgery for older patients, as for breast fed patients, they will be instructed for 4 hours for breast feeding and for formula fed patients they will be instructed to fast for 6 hours as recommended by the American society of anesthesiologists. Preoperative assessment will be done before surgery by one of the members of the team who will make sure that the inclusion and exclusion criteria of the patients are considered, and baseline vital signs will be recorded. According to randomization that will be done by envelop concealed allocation , the drug will be administered to the patients by a researcher who will not participate in the evaluation of the patients 30 mins before transfer to the operation room (OR): each group will receive the intervention drug Parents are not allowed to accompany their children to the OR according to the hospital policy. On arrival to the OR department the Parental separation anxiety scale (PSAS) will be calculated on entering the operation room standard monitoring will be commenced including ECG, non-invasive blood pressure and pulse oximetry and baseline measurement will be recorded. Inhalational induction will be then started with sevoflurane and mask acceptance will be calculated according to the mask acceptance scale (MAS) intravenous cannulation will be then established after which each patient will receive 1-2 mg/kg Propofol, 1 µg/kg fentanyl to attenuate the stress of intubation and 0.5mg/kg atracurium after tracheal intubation anesthesia will be maintained with sevoflurane 2-4 MAC During the length of the operation vital data will be recorded at 5 minutes interval. all patients will receive IV paracetamol 15mg/kg and patient would receive 1 µg/kg fentanyl as a rescue dose if vital data increased by >20% of the baseline. after the completion of surgery extubating will be performed after meeting extubation criteria and patient will be discharged to post-anesthesia care unit (PACU) in for the first 15 min after admission to PACU the post anesthesia emergence agitation will be assessed by using Pediatric Anesthesia Emergence Delirium Scale (PAED) during the stay in PACU pain will also be assessed by using FLACC score Discharge from PACU will be done after meeting discharge criteria and the time of discharge will be documented. After discharge pain score will be measured using FLACC score at 15, 30, 60 minutes interval postoperative and the total combustion of postoperative analgesics will be calculated as well as the time of discharge from the hospital

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Acute, Emergence Agitation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group D
Arm Type
Active Comparator
Arm Description
will receive placebo ODF and nebulized dexmedetomidine (Precedex™ rxlist)
Arm Title
group M
Arm Type
Active Comparator
Arm Description
will receive placebo nebulizer and ODF melatonin (metacyst ™ nerhadou)
Arm Title
group C
Arm Type
Placebo Comparator
Arm Description
will receive placebo ODF and placebo 0.9% normal saline nebulizer
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex™ rxlist
Intervention Description
receive placebo ODF and 3 µ/kg nebulized dexmedetomidine (Precedex™ rxlist) prepared in 0.9% normal saline to a final volume of 3ml. Nebulization was performed using a wall nebulizer and wall oxygen source on 4 l/min.
Intervention Type
Drug
Intervention Name(s)
Melatonin
Other Intervention Name(s)
metacyst ™ nerhadou
Intervention Description
will receive placebo nebulizer and 0.4mg/kg of ODF melatonin (metacyst ™ nerhadou) orally allowing the film to dissolve in the patients Oro mucosal lining
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
normal saline
Intervention Description
placebo ODF and 0.9% normal saline nebulizer
Primary Outcome Measure Information:
Title
perioperative anxiety
Description
perioperative anxiety will be measured by using Parental separation anxiety scale (PSAS) will be calculated according to the following: Behavior of the child during separation from parents will be Excellent if the Patient unafraid, cooperative, or asleep will be given the score of (1) Behavior of the child during separation from parents will be Good if the patient is Slightly afraid/crying, quiet with reassurance will be given the score (2) Behavior of the child during separation from parents will be Fair if the patient is Moderately afraid and crying not quit with reassurance with the score (3) Behavior of the child during separation from parents will be poor if the patient is Crying, need for restraint with the score (4) the score of (1) means excellent response , score of (2) means good response , score of (3) means fair response and score of (4) means poor response
Time Frame
during the patient separation from the caregiver just as the child is going to the operating theater
Secondary Outcome Measure Information:
Title
mask acceptance
Description
calculated according to the mask acceptance scale (MAS) as following : if the Child is calm, cooperative, or asleep the score will be (1) if the child is in Moderate fear of the mask Manageable with reassurance the score will be(2) if the child Cries, combative and needs restraining the score will be (3) score of (1) means excellent response ,score of (2) means fair response and score of (3) means poor response
Time Frame
during the mask introduction to start inhalational induction of anesthesia with sevoflurane before skin incision
Title
post anesthesia emergence agitation
Description
will be assessed by using Pediatric Anesthesia Emergence Delirium Scale (PAED) with score 1= calm , 2= not calm but could be easily consoled , 3= moderately agitated or restless and not easily calmed , 4 = combative , excited , thrashing around
Time Frame
first 15 minutes after admission to post- anesthesia care unit
Title
pain score
Description
using Face, leg, activity, cry and Consolability score With score of 0 meaning no pain and requires no intervention and score of 10 indicating the worst imaginable pain requiring rescue analgesia
Time Frame
during hospital stay up to 3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients of American Society of Anesthesiologists (ASA) physical status I & II both genders, ≥ 2 to 10 years, scheduled for elective day case surgery under general anesthesia Exclusion Criteria: parents' refusal for participation in the study ASA III and VI patients with history of chronic illness runny nose or upper respiratory tract infection Emergency surgeries with hemodynamic instability history of allergic reaction to dexmedetomidine or melatonin History of prematurity developmental delay central nervous system disorder, mental retardation, neurological or psychiatric illness that may be associated with anxiety and agitation (cerebral palsy, seizure, separation anxiety disorder, ADHD etc.). treatment with anticonvulsants and sedatives
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nada M Aboelrouse, masters
Phone
00201003371346
Email
nadaaboelrouse21@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed A Tolba, MD
Phone
0020115 6622298
Email
Mohamedtolba@med.asu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sohair Abbas, MD
Organizational Affiliation
Ain Shams University, Anesthesia department
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ramy Mahrose, MD
Organizational Affiliation
Ain Shams University, Anesthesia department
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Wessam Zaher, MD
Organizational Affiliation
Ain Shams University, Anesthesia department
Official's Role
Study Director
Facility Information:
Facility Name
Ain shams university hospital
City
Cairo
State/Province
Abbasia
ZIP/Postal Code
11213
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nada M Aboelrouse, masters
Phone
00201003371346
Email
nadaaboelrouse21@gmail.com
First Name & Middle Initial & Last Name & Degree
mohamed A Tolba, MD
Phone
01156622298
Email
Mohamedtolba@med.asu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

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Nebulized Dexmedetomidine VS ODF Melatonin for Peri Operative Anxiety and Emergence Agitation in Pediatric Day Surgery

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