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Volumes of Administration for Intranasal Midazolam

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ClinicalTrials.gov Identifier: NCT01948908
Recruitment Status : Completed
First Posted : September 24, 2013
Results First Posted : May 5, 2016
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Daniel S Tsze, MD, MPH, Columbia University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Children Requiring Sedation to Facilitate Laceration Repair Drug: Intranasal midazolam Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimal Volumes of Administration for Intranasal Midazolam in Children
Study Start Date : June 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 200 mcL VOA
Intranasal midazolam administered in 200 mcL VOA
 Drug: Intranasal midazolam
Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
Other Name: No other name
Experimental: 500 mcL VOA
Intranasal midazolam administered in 500 mcL VOA.
 Drug: Intranasal midazolam
Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
Other Name: No other name
Experimental: 1000 mcL VOA
Intranasal midazolam administered in 1000 mcL VOA.
 Drug: Intranasal midazolam
Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
Other Name: No other name


Outcome Measures
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Primary Outcome Measures :
  1. Median Time (Minutes) After Administration of Intranasal Midazolam Until Patient Achieves Minimal Sedation [ Time Frame: 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 :
  1. Observational Scale of Behavioral Distress - Revised [ Time Frame: 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.

  2. Number of Patients With Physicians Who Were Satisfied or Very Satisfied With Ease of Medication Administration [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01948908


Locations
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United States, New York
New York Presbyterian Morgan Stanley Children's Hospital
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Daniel S Tsze, MD, MPH Columbia University
More Information
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Publications of Results:

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Responsible Party: Daniel S Tsze, MD, MPH, Assistant Professor of Pediatrics, Columbia University
ClinicalTrials.gov Identifier: NCT01948908    
Other Study ID Numbers: AAAL7510
First Posted: September 24, 2013    Key Record Dates
Results First Posted: May 5, 2016
Last Update Posted: April 30, 2019
Last Verified: April 2019
Keywords provided by Daniel S Tsze, MD, MPH, Columbia University:
Sedation
Laceration repair
Children
Intranasal
Midazolam
Additional relevant MeSH terms:
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Lacerations
Wounds and Injuries
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
 Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action