Phase 2
N=101
Dose-Finding Study of Intranasal Midazolam for Procedural Sedation in Children
Procedural Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT04586504 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Number of Children Who Achieved PSSS Score 2, 3, or 4 for 95% or Greater of the Scored Procedure — 9; 12; 20; 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Intranasal midazolam (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Children Who Achieved PSSS Score 2, 3, or 4 for 95% or Greater of the Scored Procedure |
9; 12; 20; 19 | — |
| SECONDARY Time to Recovery |
0; 0; 0; 0 | — |
| SECONDARY Number of Adverse Events |
0; 0; 2; 0 | — |
| SECONDARY Time to Onset of Minimal Sedation |
4.2; 3.7; 3.9; 3.9 | — |
| SECONDARY UMSS Scale Score |
3; 2; 1; 2; 16; 22 | — |
Summary
Dose-finding study to compare intranasal midazolam doses of 0.2, 0.3, 0.4 and 0.5 mg/kg in children undergoing laceration repair to achieve the following aims:
Specific Aim #1: To determine the most effective dose of intranasal midazolam for producing adequate sedation state associated with each dose.
Specific Aim #2: To determine the time to recovery and describe the adverse events associated with each dose.
Eligibility Criteria
Inclusion Criteria
- Ages 6 months to 7 years old (i.e. before their 8th birthday)
- Simple laceration
- Attending physician has decided intranasal midazolam indicated to facilitate repair
Exclusion Criteria
- Repair using tissue adhesive (e.g. Dermabond) or staples
- Known or confirmed developmental delay
- Baseline motor neurological abnormality (e.g. motor deficit, cerebral palsy)
- Autism spectrum disorder
- Illness associated with chronic pain
- Known allergy to midazolam or any other benzodiazepine
- Eyelid laceration
- Tongue or intraoral lacerations
- Nasal obstruction that cannot be easily cleared
- Does not speak English or Spanish
- Foster children, wards of the state
Data sourced from ClinicalTrials.gov (NCT04586504). 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.