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Efficacy and safety of oral midazolam solution for sedation in a pediatric population before medical examination, surgery, or treatment: a single-arm, multicenter, phase IV clinical trial.

To evaluate the efficacy and safety of oral midazolam solution for sedation in the pediatric population during medical examination, before surgery, or before treatment: a single-arm, multicenter phase IV clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076185
Enrollment
Unknown
Registered
2023-09-27
Start date
2023-09-29
Completion date
Unknown
Last updated
2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedation

Interventions

Experimental group:Oral midazolam solution was given orally

Sponsors

The Third Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.5 Years to 16 Years

Inclusion criteria

Inclusion criteria: 1) 6 months = age = 16 years old, regardless of gender; 2) ASA is classified as I-III; 3) Pediatric patients who require medication sedation before medical examination (such as CT, B-ultrasound, etc.), surgery, or treatment; 4) The guardian and/or patient agree to participate in this trial and voluntarily sign an informed consent form. (The guardian must sign the guardian version of the informed consent form, and children over the age of 8 should sign the minor version of the informed consent form).

Exclusion criteria

Exclusion criteria: 1) allergic to the composition of oral midazolam solution; 2) acute angle-closure glaucoma or untreated open Angle glaucoma; 3) participants participating in an interventional clinical trial; 4) Subjects deemed by the investigator to be ineligible for the trial.

Design outcomes

Primary

MeasureTime frame
Ramsay sedation score;

Secondary

MeasureTime frame
Anti-anxiety score;Degree of cooperation score;Satisfaction rating;Pharmacokinetics/pharmacodynamics;

Countries

China

Contacts

Public ContactWen Ouyang

The Third Xiangya Hospital of Central South University

ouyangwen133@vip.sina.com+86 139 7493 4441

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026