Clinical trial NCT01948908: Volumes of Administration for Intranasal Midazolam
Official title: Optimal Volumes of Administration for Intranasal Midazolam in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Children Requiring Sedation to Facilitate Laceration Repair
Keywords: Sedation
Laceration repair
Children
Intranasal
Midazolam
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2013-09-24
Enrollment: 99
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Median Time (Minutes) After Administration of Intranasal Midazolam Until Patient Achieves Minimal Sedation
timeFrame: 20 minutes
Secondary outcomes:
measure: Observational Scale of Behavioral Distress - Revised
timeFrame: 60 minutes
measure: Number of Patients With Physicians Who Were Satisfied or Very Satisfied With Ease of Medication Administration
timeFrame: 60 minutes
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Morgan Stanley Children's Hospital
state: New York
Study officials:
affiliation: Columbia University
name: Daniel S Tsze, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 2016 Nov 4.