Phase 2
Completed N=99
Volumes of Administration for Intranasal Midazolam
Children Requiring Sedation to Facilitate Laceration Repair
Source: ClinicalTrials.gov NCT01948908 ↗
Enrolled (actual)
99
Serious AEs
0.0%
Results posted
May 2016
Primary outcomePrimary: Median Time (Minutes) After Administration of Intranasal Midazolam Until Patient Achieves Minimal Sedation — 4.7; 4.3; 5.2 minutes
Summary
The purpose of this study is to determine exactly how much drug volume should be administered into each nare, so that the drug absorption can be maximized and the amount that runs out of the nose, or is swallowed, is minimized, thereby optimizing the effectiveness of any drug given intranasally. The investigators will determine this ideal "volume of administration" by studying intranasal midazolam in children who require sedation to facilitate laceration repairs. The investigators will evaluate both clinical outcomes as well as pharmacokinetic outcomes associated with each volume of administration. We will block randomize children to receive intranasal midazolam in maximum aliquots of one of the three following VOA: 200 microliters (mcL), 500 mcL, or 1000 mcL.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Time (Minutes) After Administration of Intranasal Midazolam Until Patient Achieves Minimal Sedation |
4.7; 4.3; 5.2 | — |
| SECONDARY Observational Scale of Behavioral Distress - Revised |
6.06; 7.90; 8.56 | — |
| SECONDARY Number of Patients With Physicians Who Were Satisfied or Very Satisfied With Ease of Medication Administration |
13; 30; 30 | — |
Eligibility Criteria
Inclusion Criteria
- 1 to 7 years of age, inclusive.
- Require intranasal midazolam for minimal sedation to facilitate laceration repair.
Exclusion Criteria
- Weight less than 10 kg.
- Known allergy to midazolam.
- Presence of intranasal obstruction (e.g. mucous or blood) that cannot be readily cleared
- Inability to speak English or Spanish
- Developmental delay, psychiatric illness, neurologic impairment, or altered mental status; or illnesses associated with chronic pain (e.g. sickle cell disease, inflammatory bowel disease).
- Foster children or wards.
Data sourced from ClinicalTrials.gov (NCT01948908). 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.