Mother's Recorded Voice Versus Dexmedetomidine on Postoperative Agitation

Agitation, Emergence Clinical Trial

Official title:

Mother's Recorded Voice: a Neglected Therapeutic Stance for Pediatric Postoperative Agitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04941508
• Other study ID #: 17300621
• Status: Completed
• Phase: Phase 3
• Start date: June 25, 2021
• Est. completion date: November 5, 2021

Study information

• Verified date: November 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 5, 2021
• Est. primary completion date: November 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Agitation, Emergence
• Emergence Delirium
• Psychomotor Agitation

Intervention

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).

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:
• 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).

Locations

Country	Name	City	State
Egypt	Assiut university hospital	Assiut
Egypt	Omar Soliman	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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;(7):CD006447. doi: 10.1002/14651858.CD006447.pub3. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 hours Postoperative
Secondary	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.	24 hours Postoperative