Phase 2 N=99 Randomized Single-blind Treatment

Volumes of Administration for Intranasal Midazolam

Children Requiring Sedation to Facilitate Laceration Repair

Bottom Line

View on ClinicalTrials.gov: NCT01948908 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2016

Primary outcome: Primary: Median Time (Minutes) After Administration of Intranasal Midazolam Until Patient Achieves Minimal Sedation — 4.7; 4.3; 5.2 minutes

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Intranasal midazolam (Drug)
Age: Pediatric · 1+ yrs
Sex: All
Sponsor: Columbia University
Primary completion: Sep 2015

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	—

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.

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.

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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.