Volumes of Administration for Intranasal Midazolam

Children Requiring Sedation to Facilitate Laceration Repair Clinical Trial

Official title:

Optimal Volumes of Administration for Intranasal Midazolam in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01948908
• Other study ID #: AAAL7510
• Status: Completed
• Phase: Phase 2
• Start date: June 2013
• Est. completion date: September 2015

Study information

• Verified date: April 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 7 Years

Eligibility

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, in?ammatory bowel disease).

• Foster children or wards.

Related Conditions & MeSH terms

• Children Requiring Sedation to Facilitate Laceration Repair
• Lacerations

Intervention

Drug:
• Intranasal midazolam
Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).

Locations

Country	Name	City	State
United States	New York Presbyterian Morgan Stanley Children's Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Tsze DS, Ieni M, Fenster DB, Babineau J, Kriger J, Levin B, Dayan PS. Optimal Volume of Administration of Intranasal Midazolam in Children: A Randomized Clinical Trial. Ann Emerg Med. 2017 May;69(5):600-609. doi: 10.1016/j.annemergmed.2016.08.450. Epub 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Time (Minutes) After Administration of Intranasal Midazolam Until Patient Achieves Minimal Sedation	This outcome is designed to examine time to onset of minimal sedation, defined as a University of Michigan Sedation Score (UMSS) of 1.	20 minutes
Secondary	Observational Scale of Behavioral Distress - Revised	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.	60 minutes
Secondary	Number of Patients With Physicians Who Were Satisfied or Very Satisfied With Ease of Medication Administration	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.	60 minutes