Volumes of Administration for Intranasal Midazolam

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Children Requiring Sedation to Facilitate Laceration Repair

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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200 mcL VOA

Intranasal midazolam administered in 200 mcL VOA

Group Type EXPERIMENTAL

Intranasal midazolam

Intervention Type DRUG

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

500 mcL VOA

Intranasal midazolam administered in 500 mcL VOA.

Group Type EXPERIMENTAL

Intranasal midazolam

Intervention Type DRUG

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

1000 mcL VOA

Intranasal midazolam administered in 1000 mcL VOA.

Group Type EXPERIMENTAL

Intranasal midazolam

Intervention Type DRUG

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

Interventions

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Intranasal midazolam

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

Intervention Type DRUG

Other Intervention Names

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No other name

Eligibility Criteria

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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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No