Volumes of Administration for Intranasal Midazolam

Columbia University

Status and phase: Completed; Phase 2

Conditions: Children Requiring Sedation to Facilitate Laceration Repair

Treatments: Drug: Intranasal midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT01948908

AAAL7510

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 1 to 7 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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99 participants in 3 patient groups

200 mcL VOA

Experimental group

Description:

Intranasal midazolam administered in 200 mcL VOA

Treatment:

Drug: Intranasal midazolam

500 mcL VOA

Experimental group

Description:

Intranasal midazolam administered in 500 mcL VOA.

Treatment:

Drug: Intranasal midazolam

1000 mcL VOA

Experimental group

Description:

Intranasal midazolam administered in 1000 mcL VOA.

Treatment:

Drug: Intranasal midazolam