Phase 4
Completed N=15
Intranasal Midazolam in Children as a Pre-Operative Sedative
Sedation, Conscious
Source: ClinicalTrials.gov NCT02314546 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcomePrimary: Sedation Scale Score — 0; 0; 0; 1 participants — p=0.99
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sedation Scale Score |
0; 0; 0; 1; 1; 1 | 0.99 |
| PRIMARY Time From Administration to Discharge |
87.0; 74.2; 97.0 | 0.26 |
| SECONDARY Parental Observed Behavioral Distress Score |
0.08; 3.10; 1.96 | 0.02 sig |
| SECONDARY RN Observed Behavioral Distress Score |
0.1; 2.4; 1.9 | 0.04 sig |
| SECONDARY Verbal Complaint |
3; 1; 2; 2; 4; 3 | 0.73 |
| SECONDARY Verbal Complaints |
5; 3; 4; 0; 2; 1 | 0.73 |
Eligibility Criteria
Inclusion Criteria
- Children aged 18 months-7 years, scheduled for a minor otolaryngology (ENT) 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 OBD 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 (NCT02314546). 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.