Trial · NCT00675909
Improving Sedation of Children Undergoing Procedures in the Emergency Department
NCT00675909, Not applicable, Completed, Seattle Children's Hospital; results first posted 2012-06-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Improving Sedation of Children Undergoing Procedures in the Emergency Department. Trials, record NCT00675909. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00675909
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Improving Sedation of Children Undergoing Procedures in the Emergency Department
- NCT number
- NCT00675909
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 180 participants, actual
- Lead sponsor
- Seattle Children's Hospital
- Conditions
- Anxiety
- Interventions
- Aerosolized Intranasal midazolam, Aerosolized Buccal Midazolam, Oral midazolam
- First posted
- 2008-05-12
- Last updated
- 2018-11-09
- Results first posted
- 2012-06-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in CHEOPS Score Measured Level of Sedation From Baseline (Presentation in ED, Before Sedation) to Start of Procedure (Laceration Repair). | Baseline (presentation, before sedation) in ED to start of procedure (laceration repair). | Modified CHEOPS (Children's Hospital of Eastern Ontario Pain Scale)assessment used to score sedation. Scale range is 0-10 with 0 meaning no pain and 4 or greater meaning pain. Scale is determined by assessing Facial Expression (0-2), Cry (0-3), Child Verbal (0-2) and Movements (0-3). |
| Secondary | Time From Study Drug Administration to Start of Procedure | Time from study drug administration to start of procedure up to 68 minutes | |
| Secondary | Duration of Procedure | Duration of procedure up to 40 minutes | |
| Secondary | Physician Rating of Sedation | Physician was asked after the procedure was done about their impression of sedation. | Range is 0-10. Higher is associated with physician impression that sedation is better. |
| Secondary | Nurse Rating of Sedation | After the procedure nurse was asked about their impression of the level of sedation. | Range is 0-10. Higher is associated with nurse impression that sedation is better. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in CHEOPS Score Measured Level of Sedation From Baseline (Presentation in ED, Before Sedation) to Start of Procedure (Laceration Repair). | Baseline (presentation, before sedation) in ED to start of procedure (laceration repair). | Intention to treat | Scores on a scale | MEDIAN |
| SECONDARY | Time From Study Drug Administration to Start of Procedure | Time from study drug administration to start of procedure up to 68 minutes | minutes | MEDIAN | |
| SECONDARY | Duration of Procedure | Duration of procedure up to 40 minutes | minutes | MEDIAN | |
| SECONDARY | Physician Rating of Sedation | Physician was asked after the procedure was done about their impression of sedation. | units on a scale | MEDIAN | |
| SECONDARY | Nurse Rating of Sedation | After the procedure nurse was asked about their impression of the level of sedation. | units on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in CHEOPS Score Measured Level of Sedation From Baseline (Presentation in ED, Before Sedation) to Start of Procedure (Laceration Repair). | Oral Midazolam | 2 | 95% Confidence Interval -2 to 7 | Scores on a scale | |
| Change in CHEOPS Score Measured Level of Sedation From Baseline (Presentation in ED, Before Sedation) to Start of Procedure (Laceration Repair). | Intranasal Midazolam | 2 | 95% Confidence Interval -3 to 7 | Scores on a scale | |
| Change in CHEOPS Score Measured Level of Sedation From Baseline (Presentation in ED, Before Sedation) to Start of Procedure (Laceration Repair). | Buccal Midazolam | 1 | 95% Confidence Interval -6 to 6 | Scores on a scale | |
| Time From Study Drug Administration to Start of Procedure | Oral Midazolam | 34 | Full Range 11 to 68 | minutes | |
| Time From Study Drug Administration to Start of Procedure | Intranasal Midazolam | 28 | Full Range 5 to 60 | minutes | |
| Time From Study Drug Administration to Start of Procedure | Buccal Midazolam | 32 | Full Range 10 to 59 | minutes | |
| Duration of Procedure | Oral Midazolam | 12 | Full Range 1 to 40 | minutes | |
| Duration of Procedure | Intranasal Midazolam | 12 | Full Range 1 to 40 | minutes | |
| Duration of Procedure | Buccal Midazolam | 10 | Full Range 1 to 39 | minutes | |
| Physician Rating of Sedation | Oral Midazolam | 6.7 | Full Range 0 to 10 | units on a scale |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oral Midazolam | 60 | |
| Overall Study | STARTED | Buccal Midazolam | 60 | |
| Overall Study | STARTED | Intranasal Midazolam | 60 | |
| Overall Study | COMPLETED | Oral Midazolam | 60 | |
| Overall Study | COMPLETED | Buccal Midazolam | 60 | |
| Overall Study | COMPLETED | Intranasal Midazolam | 60 | |
| Overall Study | NOT COMPLETED | Oral Midazolam | 0 | |
| Overall Study | NOT COMPLETED | Buccal Midazolam | 0 | |
| Overall Study | NOT COMPLETED | Intranasal Midazolam | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oral Midazolam | ||
| Total, all-cause mortality | Buccal Midazolam | ||
| Total, all-cause mortality | Intranasal Midazolam | ||
| Total, other adverse events | Oral Midazolam | 0 | 60 |
| Total, other adverse events | Buccal Midazolam | 0 | 60 |
| Total, other adverse events | Intranasal Midazolam | 0 | 60 |
| Total, serious adverse events | Oral Midazolam | 0 | 60 |
| Total, serious adverse events | Buccal Midazolam | 0 | 60 |
| Total, serious adverse events | Intranasal Midazolam | 0 | 60 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21689865 | 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.
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/NCT00675909
GET https://conductscience.org/api/trials/v1/NCT00675909/registered