Trial · NCT01948908

Volumes of Administration for Intranasal Midazolam

NCT01948908, Phase 2, Completed, Columbia University; results first posted 2016-05-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Volumes of Administration for Intranasal Midazolam. Trials, record NCT01948908. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01948908

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Volumes of Administration for Intranasal Midazolam
NCT number: NCT01948908
Status: Completed
Phases: Phase 2
Enrollment: 99 participants, actual
Lead sponsor: Columbia University
Conditions: Children Requiring Sedation to Facilitate Laceration Repair
Interventions: Intranasal midazolam
First posted: 2013-09-24
Last updated: 2019-04-30
Results first posted: 2016-05-05

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Median Time (Minutes) After Administration of Intranasal Midazolam Until Patient Achieves Minimal Sedation	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	Observational Scale of Behavioral Distress - Revised	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.
Secondary	Number of Patients With Physicians Who Were Satisfied or Very Satisfied With Ease of Medication Administration	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.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Median Time (Minutes) After Administration of Intranasal Midazolam Until Patient Achieves Minimal Sedation	20 minutes	minutes	MEDIAN
SECONDARY	Observational Scale of Behavioral Distress - Revised	60 minutes	units	MEAN
SECONDARY	Number of Patients With Physicians Who Were Satisfied or Very Satisfied With Ease of Medication Administration	60 minutes	participants	NUMBER

Source ClinicalTrials.gov

Results by group9

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Median Time (Minutes) After Administration of Intranasal Midazolam Until Patient Achieves Minimal Sedation	200 mcL VOA	4.7	95% Confidence Interval 3.8 to 5.4	minutes
Median Time (Minutes) After Administration of Intranasal Midazolam Until Patient Achieves Minimal Sedation	500 mcL VOA	4.3	95% Confidence Interval 3.9 to 4.9	minutes
Median Time (Minutes) After Administration of Intranasal Midazolam Until Patient Achieves Minimal Sedation	1000 mcL VOA	5.2	95% Confidence Interval 4.6 to 7	minutes
Observational Scale of Behavioral Distress - Revised	200 mcL VOA	6.06	95% Confidence Interval 3.68 to 8.44	units
Observational Scale of Behavioral Distress - Revised	500 mcL VOA	7.90	95% Confidence Interval 4.95 to 10.85	units
Observational Scale of Behavioral Distress - Revised	1000 mcL VOA	8.56	95% Confidence Interval 5.75 to 11.37	units
Number of Patients With Physicians Who Were Satisfied or Very Satisfied With Ease of Medication Administration	200 mcL VOA	13		participants
Number of Patients With Physicians Who Were Satisfied or Very Satisfied With Ease of Medication Administration	500 mcL VOA	30		participants
Number of Patients With Physicians Who Were Satisfied or Very Satisfied With Ease of Medication Administration	1000 mcL VOA	30		participants

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	200 mcL VOA	33
Overall Study	STARTED	500 mcL VOA	33
Overall Study	STARTED	1000 mcL VOA	33
Overall Study	COMPLETED	200 mcL VOA	32
Overall Study	COMPLETED	500 mcL VOA	33
Overall Study	COMPLETED	1000 mcL VOA	31
Overall Study	NOT COMPLETED	200 mcL VOA	1
Overall Study	NOT COMPLETED	500 mcL VOA	0
Overall Study	NOT COMPLETED	1000 mcL VOA	2

Source ClinicalTrials.gov

Adverse events6

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Vomiting	Gastrointestinal disorders	200 mcL VOA	0	32
other	Vomiting	Gastrointestinal disorders	500 mcL VOA	2	33
other	Vomiting	Gastrointestinal disorders	1000 mcL VOA	1	31
other	Inadequate sedation	Surgical and medical procedures	200 mcL VOA	0	32
other	Inadequate sedation	Surgical and medical procedures	500 mcL VOA	2	33
other	Inadequate sedation	Surgical and medical procedures	1000 mcL VOA	0	31

Source ClinicalTrials.gov

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	200 mcL VOA
Total, all-cause mortality	500 mcL VOA
Total, all-cause mortality	1000 mcL VOA
Total, other adverse events	200 mcL VOA	0	32
Total, other adverse events	500 mcL VOA	4	33
Total, other adverse events	1000 mcL VOA	1	31
Total, serious adverse events	200 mcL VOA	0	32
Total, serious adverse events	500 mcL VOA	0	33
Total, serious adverse events	1000 mcL VOA	0	31

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
27823876	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01948908

GET https://conductscience.org/api/trials/v1/NCT01948908/registered

API reference For AI assistants