NCT04941508

Mother's Recorded Voice Versus Dexmedetomidine on Postoperative Agitation

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 4 Years – 9 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Agitation, Emergence

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2021-06-25
• Primary completion: 2021-11-03
• Completion: 2021-11-05
• First posted: 2021-06-28
• Last updated: 2021-11-18

Locations

2 sites across 1 country: Egypt