NCT01948908

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 24, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
8 months until next milestone

Results Posted

Study results publicly available

May 5, 2016

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

2.3 years

First QC Date

June 29, 2013

Results QC Date

March 5, 2016

Last Update Submit

April 17, 2019

Conditions

Children Requiring Sedation to Facilitate Laceration Repair

Keywords

SedationLaceration repairChildrenIntranasalMidazolam

Outcome Measures

Primary Outcomes (1)

  • Median Time (Minutes) After Administration of Intranasal Midazolam Until Patient Achieves Minimal Sedation

    This outcome is designed to examine time to onset of minimal sedation, defined as a University of Michigan Sedation Score (UMSS) of 1.

    20 minutes

Secondary Outcomes (2)

  • Observational Scale of Behavioral Distress - Revised

    60 minutes

  • Number of Patients With Physicians Who Were Satisfied or Very Satisfied With Ease of Medication Administration

    60 minutes

Study Arms (3)

200 mcL VOA

EXPERIMENTAL

Intranasal midazolam administered in 200 mcL VOA

Drug: Intranasal midazolam

500 mcL VOA

EXPERIMENTAL

Intranasal midazolam administered in 500 mcL VOA.

Drug: Intranasal midazolam

1000 mcL VOA

EXPERIMENTAL

Intranasal midazolam administered in 1000 mcL VOA.

Drug: Intranasal midazolam

Interventions

Intranasal midazolamDRUG

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

Also known as: No other name
1000 mcL VOA200 mcL VOA500 mcL VOA

Eligibility Criteria

Age1 Year - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • to 7 years of age, inclusive.
  • Require intranasal midazolam for minimal sedation to facilitate laceration repair.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Presbyterian Morgan Stanley Children's Hospital

New York, New York, 10032, United States

Location

Related Publications (1)

  • Tsze DS, Ieni M, Fenster DB, Babineau J, Kriger J, Levin B, Dayan PS. Optimal Volume of Administration of Intranasal Midazolam in Children: A Randomized Clinical Trial. Ann Emerg Med. 2017 May;69(5):600-609. doi: 10.1016/j.annemergmed.2016.08.450. Epub 2016 Nov 4.

    PMID: 27823876RESULT

Results Point of Contact

Title
Daniel S. Tsze
Organization
Columbia University College of Physicians and Surgeons
dst2141@columbia.edu
212-305-9825

Study Officials

  • Daniel S Tsze, MD, MPH

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

June 29, 2013

First Posted

September 24, 2013

Study Start

June 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

April 30, 2019

Results First Posted

May 5, 2016

Record last verified: 2019-04

Locations

US(1)