Mother's Recorded Voice Versus Dexmedetomidine on Postoperative Agitation
Primary Purpose
Agitation, Emergence
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
the mother's recorded voice
Dexmedetomidine
saline 0.9% placebo
Sponsored by
About this trial
This is an interventional treatment trial for Agitation, Emergence
Eligibility Criteria
Inclusion Criteria:
- Children (age 4-9 years)
- American Society of Anesthesiologists physical status (ASA) I-II who will be listed for outpatient elective surgery under general anesthesia.
Exclusion Criteria:
- Developmental delays
- Neurological diseases
- Deafness
- Hearing impairment
- Maternal mutism
- Absence of the mother
Sites / Locations
- Assiut university hospital
- Omar Soliman
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Mother's recorded voice
Dexmedetomidine IV
Saline placebo IV
Arm Description
Children will be exposed to the mother's voice.
Children will be given dexmedetomidine injection.
Children will be given normal saline.
Outcomes
Primary Outcome Measures
Pediatric anesthesia of emergence delirium (PAED) score
Emergence delirium (ED) will be measured by the pediatric anesthesia of emergence delirium (PAED).The scores for each of the five listed behaviours(makes eye contact with caregiver, actions are purposeful,aware of surroundings, restless and inconsolable) are added to achieve a total score (maximum score of 20). A score of >12 yields 100% sensitivity and 94.5% specificity for the diagnosis of ED
Secondary Outcome Measures
Face, Legs, Activity, Cry, and Consolability (FLACC) score
Pain will be measured by Face, Legs, Activity, Cry, and Consolability (FLACC) score ranging from 0 to 10 where 0= relaxed and no pain, 1-3= mild pain/discomfort, 4-6= moderate pain, 7-10= severe discomfort/pain.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04941508
Brief Title
Mother's Recorded Voice Versus Dexmedetomidine on Postoperative Agitation
Official Title
Mother's Recorded Voice: a Neglected Therapeutic Stance for Pediatric Postoperative Agitation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
June 25, 2021 (Actual)
Primary Completion Date
November 3, 2021 (Actual)
Study Completion Date
November 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
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 aim of this study is to compare the efficacy of mother's recorded voice versus dexmedetomidine injection on postoperative agitation in children undergoing elective surgery.
Detailed Description
A written informed consent will be taken from the patients' legal guardians.Patients will be assigned randomly to three groups (30 subjects each) to be anesthetized and either randomly assigned to listen to the mother's recorded voice at 2 times (in the holding area 3 minutes before induction of anesthesia till induction of anesthesia is ended) and (during emergence from anesthesia till complete recovery) (Group M) or will be given a single bolus of dexmedetomidine 0.2 µ/kg IV at 2 times (in the holding area 3 minutes before induction of anesthesia) and (at the end of surgery) (Group D) or given the same volume of saline IV at 2 times (in the holding area 3 minutes before induction of anesthesia) and (at the end of surgery) (Group C).To keep blinding, group M will be injected IV with the same volume of saline at the same 2 times as in groups D & C while in groups D & C, headphones will be putted as in group M at the same 2 times with no recorded voice.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation, Emergence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mother's recorded voice
Arm Type
Experimental
Arm Description
Children will be exposed to the mother's voice.
Arm Title
Dexmedetomidine IV
Arm Type
Experimental
Arm Description
Children will be given dexmedetomidine injection.
Arm Title
Saline placebo IV
Arm Type
Placebo Comparator
Arm Description
Children will be given normal saline.
Intervention Type
Behavioral
Intervention Name(s)
the mother's recorded voice
Intervention Description
Children will be assigned to listen to the mother's recorded voice at 2 times (in the holding area 3 minutes before induction of anesthesia till induction of anesthesia is ended) and (during emergence from anesthesia till complete recovery).
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
Children will be given a single bolus of dexmedetomidine 0.2 µ/kg IV at 2 times (in the holding area 3 minutes before induction of anesthesia) and (at the end of surgery).
Intervention Type
Other
Intervention Name(s)
saline 0.9% placebo
Other Intervention Name(s)
Normal saline
Intervention Description
Children will be given the same volume of saline at 2 times (in the holding area 3 minutes before induction of anesthesia) and (at the end of surgery).
Primary Outcome Measure Information:
Title
Pediatric anesthesia of emergence delirium (PAED) score
Description
Emergence delirium (ED) will be measured by the pediatric anesthesia of emergence delirium (PAED).The scores for each of the five listed behaviours(makes eye contact with caregiver, actions are purposeful,aware of surroundings, restless and inconsolable) are added to achieve a total score (maximum score of 20). A score of >12 yields 100% sensitivity and 94.5% specificity for the diagnosis of ED
Time Frame
2 hours Postoperative
Secondary Outcome Measure Information:
Title
Face, Legs, Activity, Cry, and Consolability (FLACC) score
Description
Pain will be measured by Face, Legs, Activity, Cry, and Consolability (FLACC) score ranging from 0 to 10 where 0= relaxed and no pain, 1-3= mild pain/discomfort, 4-6= moderate pain, 7-10= severe discomfort/pain.
Time Frame
24 hours Postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children (age 4-9 years)
American Society of Anesthesiologists physical status (ASA) I-II who will be listed for outpatient elective surgery under general anesthesia.
Exclusion Criteria:
Developmental delays
Neurological diseases
Deafness
Hearing impairment
Maternal mutism
Absence of the mother
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar Soliman, MD
Organizational Affiliation
Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Assiut university hospital
City
Assiut
ZIP/Postal Code
Assuit university
Country
Egypt
Facility Name
Omar Soliman
City
Assuit
ZIP/Postal Code
Assuit universi
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26171895
Citation
Manyande A, Cyna AM, Yip P, Chooi C, Middleton P. Non-pharmacological interventions for assisting the induction of anaesthesia in children. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD006447. doi: 10.1002/14651858.CD006447.pub3.
Results Reference
result
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Mother's Recorded Voice Versus Dexmedetomidine on Postoperative Agitation
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