Phase 4
Completed N=42
Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2
Source: ClinicalTrials.gov NCT02356705 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement — 11; 3; 6; 1 Participants — p=0.39
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Midazolam is often given before surgery to sedate a patient before anesthesia is given. Children are often given a small dose either by mouth or squirted into the nose. Children will often spit out the oral midazolam, making it difficult to know how much medicine, if any, they have received. Giving midazolam into the nose is more reliable, but children may complain of pain, stinging, and may become upset due to the discomfort. Nosebleeds may also occur when midazolam is squirted alone into the nose. The purpose of this study is to see if adding a numbing medicine, xylocaine, to the nasal midazolam makes giving the midazolam easier and more comfortable without affecting how the midazolam works as a sedative. This is follow up to the pilot study, Project # 994. This will expand the previous study, with additional participants and revised xylocaine concentration
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement |
11; 3; 6; 1; 1; 3 | 0.39 |
| SECONDARY Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room |
5; 1; 1; 1; 3; 3 | 0.39 |
Eligibility Criteria
Inclusion Criteria
- Children aged 18 months-7 years, scheduled for a minor Ear/Nose/Throat surgical procedure requiring mask anesthesia
- American Society of Anesthesiologists (ASA) Class 1 or 2
- Parent willing and able to provide written informed consent
- Parent willing and able to complete the Observed Behavioral Distress (OBD) Visual Assessment Scale (VAS)
Exclusion Criteria
- ASA Class 3 or greater
- History of allergy to midazolam or xylocaine
- Presence of acute respiratory infection at time of surgery
- Parent unwilling or unable to provide informed consent
- Parent unwilling or unable to complete the OBD VAS
Data sourced from ClinicalTrials.gov (NCT02356705). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.