A pilot randomised open-label taste-testing study to evaluate the acceptability of chocolate-based midazolam in childre

Phase 1

Completed

• Conditions: Children needing a sedating premedication prior to general anaesthesia for a surgical procedure; Anaesthesiology - Anaesthetics

• Registration Number: ACTRN12615000225516
• Lead Sponsor: Princess Margaret Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-10
• Study Completion: 2016-11-23
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Male or female, 3 to 16 years of age undergoing a wide range of surgical procedures requiring a general anaesthetic.
Treating anaesthetist consider that pre-procedural midazolam is required
Obtained informed parental or guardian consent and child assent where appropriate

Exclusion Criteria

Allergic to chocolate (chocolate base does not contain nuts)
Allergic to midazolam
Unable to understand the information sheet and the consent form

Study & Design

• Study Type: Interventional
• Study Design: Not specified