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NCT04720963

Intranasal Remimazolam for Premedication in Pediatric Patient

Completed Phase 4 Last updated 8 September 2023
What this trial tests

Phase 4 trial testing Remimazolam in Sedative; Anxiety Disorder in 90 participants. Completed in 28 February 2022.

Timeline
7 February 2021
Primary endpoint
28 February 2022
28 February 2022

Quick facts

Lead sponsorSecond Affiliated Hospital of Wenzhou Medical University
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment90
Start date7 February 2021
Primary completion28 February 2022
Estimated completion28 February 2022
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Who can join

Adults 2 to 5, any sex, with Sedative; Anxiety Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Remimazolam: pharmacological characteristics and clinical applications in anesthesiology.
    Kim KM. · · 2022 · cited 161× · PMID 35139608 · DOI 10.17085/apm.21115
  2. Remimazolam: An Updated Review of a New Sedative and Anaesthetic.
    Hu Q, Liu X, Wen C, Li D, et al · · 2022 · cited 120× · PMID 36411859 · DOI 10.2147/dddt.s384155
  3. Preoperative Anxiolytic and Sedative Effects of Intranasal Remimazolam and Dexmedetomidine: A Randomized Controlled Clinical Study in Children Undergoing General Surgeries.
    Cai YH, Wang CY, Fang YB, Ma HY, et al · · 2024 · cited 14× · PMID 38774484 · DOI 10.2147/dddt.s461122
  4. Effective and safe pediatric sedation.
    Jang YE, Kim JT. · · 2024 · cited 4× · PMID 39069650 · DOI 10.17085/apm.24046

Verify or expand the search:

Other trials of Remimazolam

Trials testing the same drug.

Other Second Affiliated Hospital of Wenzhou Medical University trials

Trials by the same sponsor.

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