Optimal Volume of Administration of Intranasal Midazolam in Children: A Randomized Clinical Trial.
OBJECTIVE
The optimal intranasal volume of administration for achieving timely and effective sedation in children is unclear. We aimed to compare clinical outcomes relevant to procedural sedation associated with using escalating volumes of administration to administer intranasal midazolam.


METHODS
We conducted a randomized, single-blinded, 3-arm, superiority clinical trial. Children aged 1 to 7 years and undergoing laceration repair requiring 0.5 mg/kg intranasal midazolam (5 mg/mL) were block-randomized to receive midazolam using 1 of 3 volumes of administration: 0.2, 0.5, or 1 mL. Procedures were videotaped, with outcome assessors blinded to volume of administration. Primary outcome was time to onset of minimal sedation (ie, score of 1 on the University of Michigan Sedation Scale). Secondary outcomes included procedural distress, time to procedure start, deepest level of sedation achieved, adverse events, and clinician and caregiver satisfaction.


RESULTS
Ninety-nine children were enrolled; 96 were analyzed for the primary outcome and secondary outcomes, except for the outcome of procedural distress, for which only 90 were analyzed. Time to onset of minimal sedation for each escalating volume of administration was 4.7 minutes (95% confidence interval [CI] 3.8 to 5.4 minutes), 4.3 minutes (95% CI 3.9 to 4.9 minutes), and 5.2 minutes (95% CI 4.6 to 7.0 minutes), respectively. There were no differences in secondary outcomes except for clinician satisfaction with ease of administration: fewer clinicians were satisfied when using a volume of administration of 0.2 mL.


CONCLUSIONS
There was a slightly shorter time to onset of minimal sedation when a volume of administration of 0.5 mL was used compared with 1 mL, but all 3 volumes of administration produced comparable clinical outcomes. Fewer clinicians were satisfied with ease of administration with a volume of administration of 0.2 mL.
Department of Pediatrics, Division of Pediatric Emergency Medicine, Columbia University College of Physicians and Surgeons, New York, NY. Electronic address: dst2141@columbia.edu.
Daniel S
DS
Tsze
Department of Pediatrics, Division of Pediatric Emergency Medicine, Columbia University College of Physicians and Surgeons, New York, NY.
Maria
M
Ieni
Department of Pediatrics, Division of Pediatric Emergency Medicine, Columbia University College of Physicians and Surgeons, New York, NY.
Daniel B
DB
Fenster
Department of Pediatrics, Division of Pediatric Emergency Medicine, Columbia University College of Physicians and Surgeons, New York, NY.
John
J
Babineau
Department of Biostatistics, Columbia University Medical Center, New York, NY.
Joshua
J
Kriger
Department of Biostatistics, Columbia University Medical Center, New York, NY.
Bruce
B
Levin
Department of Pediatrics, Division of Pediatric Emergency Medicine, Columbia University College of Physicians and Surgeons, New York, NY.
Peter S
PS
Dayan
D000281:Administration, Intranasal; D002648:Child; D002675:Child, Preschool; D016292:Procedural Sedation / Q000379:methods*; D004636:Emergency Service, Hospital; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage*; D007223:Infant; D008297:Male; D008874:Midazolam / Q000008:administration & dosage*; D016037:Single-Blind Method; D013997:Time Factors
D006993:Hypnotics and Sedatives; D008874:Midazolam