NCT04720963

Intranasal Remimazolam for Premedication in Pediatric Patient

Intranasal Remimazolam for Premedication in Pediatric Patients: a Double-blinded Randomized Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Second Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 2 Years – 5 Years
• Healthy volunteers: Accepted

Summary

Anesthetic inhalation induction could be one of the most stressful experiences for children during the perioperative period, with almost 50% of them showing anxiety. It is an essential challenge for pediatric anesthesiologists on how to decrease anxiety for children in the operating room (OR) environment and to facilitate a smooth induction of anesthesia. Various factors like parental separation, unfamiliar surroundings, fear of physicians and needle injections can increase their preoperative anxiety. The researchers conducted the current study to investigate whether intranasal remimazolam can reduce anxiety in children before surgery.

Detailed description

children aged 2-5 years old were randomly allocated into three equal groups based on the premedication routes: Group R with intranasal remimazolam, Group D with intranasal dexmedetomidine and Group P with intranasal placebo, respectively.

Conditions

• Sedative; Anxiety Disorder

Interventions

Type	Name	Description
DRUG	Remimazolam	intranasal remimazolam
OTHER	Distilled water for injection	intranasal distilled water for injection
DRUG	Dexmedetomidine	Intranasal dexmedetomidine

Timeline

• Start date: 2021-02-07
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2021-01-22
• Last updated: 2023-09-08

Locations

1 site across 1 country: China