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Volumes of Administration for Intranasal Midazolam

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel Sing-Kwong Tsze, Columbia University
ClinicalTrials.gov Identifier:
NCT01948908
First received: June 29, 2013
Last updated: April 4, 2016
Last verified: April 2016
  Purpose
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 Intervention Phase
Children Requiring Sedation to Facilitate Laceration Repair
Drug: Intranasal midazolam
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimal Volumes of Administration for Intranasal Midazolam in Children

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Median Time (Minutes) After Administration of Intranasal Midazolam Until Patient Achieves Minimal Sedation [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
    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:
  • Observational Scale of Behavioral Distress - Revised [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    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.

  • Number of Patients With Physicians Who Were Satisfied or Very Satisfied With Ease of Medication Administration [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    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.


Enrollment: 99
Study Start Date: June 2013
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   1 Year to 7 Years   (Child)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01948908

Locations
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
Principal Investigator: Daniel S Tsze, MD, MPH Columbia University
  More Information

Responsible Party: Daniel Sing-Kwong Tsze, Assistant Professor of Pediatrics, Columbia University
ClinicalTrials.gov Identifier: NCT01948908     History of Changes
Other Study ID Numbers: AAAL7510 
Study First Received: June 29, 2013
Results First Received: March 5, 2016
Last Updated: April 4, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Columbia University:
Sedation
Laceration repair
Children
Intranasal
Midazolam

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 23, 2016