Volumes of Administration for Intranasal Midazolam

Phase 2

Completed

• Conditions: Children Requiring Sedation to Facilitate Laceration Repair
• Interventions: Drug: Intranasal midazolam

• Registration Number: NCT01948908
• Lead Sponsor: Columbia University

Brief 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.

Detailed Description

The intranasal route is an effective means of administering sedative medications for children. However, sometimes the child has to receive a certain dose that requires a very large volume to be administered into the nose, because of the types of concentrations of drugs that are available. Most drugs are not concentrated enough so that small volumes can be consistently given, so as a result, sometimes a very large amount of medication is administered intranasally. When the amount is too large, most of the medication either runs back out the nose, or down the back of the nose and throat and is swallowed, instead of being absorbed in the nasal cavity, where it can be quickly absorbed and produce optimal effectiveness.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-29
• Study First Submitted QC: 2013-09-23
• Study First Posted: 2013-09-24
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Results First Submitted: 2016-03-05
• Results First Submitted QC: 2016-04-04
• Results First Posted: 2016-05-05
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-17
• Last Update Posted: 2019-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• 1 to 7 years of age, inclusive.
• Require intranasal midazolam for minimal sedation to facilitate laceration repair.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
200 mcL VOA	Intranasal midazolam	Intranasal midazolam administered in 200 mcL VOA
500 mcL VOA	Intranasal midazolam	Intranasal midazolam administered in 500 mcL VOA.
1000 mcL VOA	Intranasal midazolam	Intranasal midazolam administered in 1000 mcL VOA.

Primary Outcome Measures

Name	Time	Method
Median Time (Minutes) After Administration of Intranasal Midazolam Until Patient Achieves Minimal Sedation	20 minutes	This outcome is designed to examine time to onset of minimal sedation, defined as a University of Michigan Sedation Score (UMSS) of 1.

Secondary Outcome Measures

Name	Time	Method
Observational Scale of Behavioral Distress - Revised	60 minutes	The Observational Scale of Behavioral Distress - revised (OSBD-r) is an eight-factor, weighted observational scale used to measure distress associated with medical procedures in children 1 to 20 years of age. The total OSBD-r score is the sum of the OSBD-r scores for predetermined clinically relevant phases of the procedure, with each phase assigned a score from 0 to 23.5 (0=no distress, 23.5=maximum distress), based on the frequency and types of behaviors observed during a pre-determined number of 15-second intervals during each phase.
Number of Patients With Physicians Who Were Satisfied or Very Satisfied With Ease of Medication Administration	60 minutes	This outcome is designed to examine MD satisfaction with ease of administration of intranasal medication - physicians who expressed that they were satisfied or very satisfied with ease of medication administration will be counted.

Trial Locations

Locations (1)

New York Presbyterian Morgan Stanley Children's Hospital; 🇺🇸 New York, New York, United States