Mother's Recorded Voice Versus Dexmedetomidine on Postoperative Agitation
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mother's recorded voice Children will be exposed to the mother's voice. |
Behavioral: the mother's recorded voice
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).
|
| Experimental: Dexmedetomidine IV Children will be given dexmedetomidine injection. |
Drug: Dexmedetomidine
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).
Other Names:
|
| Placebo Comparator: Saline placebo IV Children will be given normal saline. |
Other: saline 0.9% placebo
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).
Other Names:
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Outcome Measures
Primary Outcome Measures
- Pediatric anesthesia of emergence delirium (PAED) score [2 hours Postoperative]
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 [24 hours Postoperative]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Children (age 4-9 years)
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American Society of Anesthesiologists physical status (ASA) I-II who will be listed for outpatient elective surgery under general anesthesia.
Exclusion Criteria:
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Developmental delays
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Neurological diseases
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Deafness
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Hearing impairment
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Maternal mutism
-
Absence of the mother
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Assiut university hospital | Assiut | Egypt | Assuit university | |
| 2 | Omar Soliman | Assuit | Egypt | Assuit universi |
Sponsors and Collaborators
- Assiut University
Investigators
- Study Director: Omar Soliman, MD, Assiut University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17300621