Volumes of Administration for Intranasal Midazolam

This study has been completed.
Information provided by (Responsible Party):
Daniel Sing-Kwong Tsze, Columbia University
ClinicalTrials.gov Identifier:
First received: June 29, 2013
Last updated: September 17, 2015
Last verified: September 2015
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.

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).
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).


Ages Eligible for Study:   1 Year to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

United States, New York
New York Presbyterian Morgan Stanley Children's Hospital
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
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: September 17, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Laceration repair

Additional relevant MeSH terms:
Wounds and Injuries
Adjuvants, Anesthesia
Anesthetics, General
Anesthetics, Intravenous
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on February 08, 2016