Volumes of Administration for Intranasal Midazolam

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Columbia University
Sponsor:
Information provided by (Responsible Party):
Daniel Sing-Kwong Tsze, Columbia University
ClinicalTrials.gov Identifier:
NCT01948908
First received: June 29, 2013
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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. The purpose of this study is to determine exactly how much volume should be administered into each nare, so that the 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.


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:
  • Time to onset of minimal sedation [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
    Time (minutes) after administration of intranasal midazolam until patient achieves minimal sedation, defined as a University of Michigan Sedation Score (UMSS) of 1.


Secondary Outcome Measures:
  • Efficacy of sedation [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    Observational Scale of Behavioral Distress - Revised (OSBD-R)

  • Serum concentrations of midazolam [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Determination of Cmax (maximum concentration) and Tmax (time to maximum concentration) of midazolam after intranasal administration.

  • BIS monitoring [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    BIS scores during procedural sedation

  • Satisfaction [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    Satisfaction of parents, proceduralist MD, and MD administering intranasal medication.


Estimated Enrollment: 128
Study Start Date: June 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (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).
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).
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).

  Eligibility

Ages Eligible for Study:   1 Year to 7 Years
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

Contacts
Contact: Daniel S Tsze, MD, MPH 212-305-9825 dst2141@columbia.edu

Locations
United States, New York
New York Presbyterian Morgan Stanley Children's Hospital Recruiting
New York, New York, United States, 10032
Principal Investigator: Daniel S Tsze, MD, MPH         
Principal Investigator: Peter S Dayan, MD, MSc         
Principal Investigator: Serge Cremers, PharmD, PhD         
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Daniel S Tsze, MD, MPH Columbia University
  More Information

No publications provided

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
Last Updated: July 21, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Lacerations
Wounds and Injuries
Midazolam
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
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 16, 2014