Trial · NCT01528891
Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation
NCT01528891, Phase 3, Completed, Peter Davis; results first posted 2015-11-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation. Trials, record NCT01528891. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01528891
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation
- NCT number
- NCT01528891
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 418 participants, actual
- Lead sponsor
- Peter Davis
- Conditions
- Tonsillectomy
- Interventions
- Dexmedetomidine, Placebo
- First posted
- 2012-02-08
- Last updated
- 2018-03-08
- Results first posted
- 2015-11-25
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Heart Rate (HR) | Heart rate was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. Heart rate was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU). | beats per minute (bpm) |
| Primary | Systolic Blood Pressure (SBP) | Systolic blood pressure (SBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. SBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU). | mmHg Two subjects with missing data points for SBP were necessarily eliminated from repeated measures analysis. |
| Primary | Diastolic Blood Pressure (DBP) | Diastolic blood pressure (DBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. DBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU). | mmHg Three subjects with missing data points for DBP were necessarily eliminated from repeated measures analysis. |
| Secondary | Incidence of Emergence Agitation (EA) | The highest PAED score for each patient within the first 30 minutes after waking up was recorded. | Using a Pediatric Anesthesia Emergence Delirium (PAED) score, emergence agitation scores will be recorded. The PAED score consists of 5 different criteria which are assessed from 0 to 4 once the patient has woken up. These criteria are then totaled; the total may range from 0 to 20, where 0 represents no emergence agitation and 20 represents maximal agitation. For this study, patients with a maximum PAED score of \>10 and \>12 were considered to be agitated. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Heart Rate (HR) | Heart rate was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. Heart rate was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU). | Heart rate values were compared between groups at each time point and within groups over time. | bpm | MEAN |
| SECONDARY | Incidence of Emergence Agitation (EA) | The highest PAED score for each patient within the first 30 minutes after waking up was recorded. | There were 2 patients in the Dexmedetomidine group and 9 patients in the placebo group who were excluded from analysis of emergence agitation. These patients were excluded because they received medications that were not a part of the anesthetic protocol and could affect their PAED score. | percentage of patients with EA | NUMBER |
| PRIMARY | Systolic Blood Pressure (SBP) | Systolic blood pressure (SBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. SBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU). | Systolic blood pressure values were compared between groups at each time point and within groups over time. | mmHg | MEAN |
| PRIMARY | Diastolic Blood Pressure (DBP) | Diastolic blood pressure (DBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. DBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU). | Diastolic blood pressure values were compared between groups at each time point and within groups over time. | mmHg | MEAN |
Source ClinicalTrials.gov
Results by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Heart Rate (HR) | Dexmedetomidine | Baseline HR | 120 | Standard Deviation 16 | bpm |
| Heart Rate (HR) | Placebo | Baseline HR | 121 | Standard Deviation 16 | bpm |
| Heart Rate (HR) | Dexmedetomidine | 1 min HR | 107 | Standard Deviation 18 | bpm |
| Heart Rate (HR) | Placebo | 1 min HR | 121 | Standard Deviation 16 | bpm |
| Heart Rate (HR) | Dexmedetomidine | 2 min HR | 104 | Standard Deviation 16 | bpm |
| Heart Rate (HR) | Placebo | 2 min HR | 120 | Standard Deviation 15 | bpm |
| Heart Rate (HR) | Dexmedetomidine | 3 min HR | 105 | Standard Deviation 14 | bpm |
| Heart Rate (HR) | Placebo | 3 min HR | 119 | Standard Deviation 15 | bpm |
| Heart Rate (HR) | Dexmedetomidine | 4 min HR | 105 | Standard Deviation 15 | bpm |
| Heart Rate (HR) | Placebo | 4 min HR | 118 | Standard Deviation 15 | bpm |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dexmedetomidine | 200 | |
| Overall Study | STARTED | Placebo | 200 | |
| Overall Study | COMPLETED | Dexmedetomidine | 200 | |
| Overall Study | COMPLETED | Placebo | 200 | |
| Overall Study | NOT COMPLETED | Dexmedetomidine | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events50
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 | Events |
|---|---|---|---|---|---|---|
| other | Dizziness | General disorders | Dexmedetomidine | 1 | 200 | 1 |
| other | Dizziness | General disorders | Placebo | 0 | 200 | 0 |
| other | Headache | General disorders | Dexmedetomidine | 1 | 200 | 1 |
| other | Headache | General disorders | Placebo | 2 | 200 | 2 |
| other | Congestion | General disorders | Dexmedetomidine | 3 | 200 | 3 |
| other | Congestion | General disorders | Placebo | 0 | 200 | 0 |
| other | Bronchospasm | General disorders | Dexmedetomidine | 0 | 200 | 0 |
| other | Bronchospasm | General disorders | Placebo | 1 | 200 | 1 |
| other | Laryngospasm | General disorders | Dexmedetomidine | 0 | 200 | 0 |
| other | Laryngospasm | General disorders | Placebo | 7 | 200 | 7 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dexmedetomidine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Dexmedetomidine | 18 | 200 |
| Total, other adverse events | Placebo | 34 | 200 |
| Total, serious adverse events | Dexmedetomidine | 1 | 200 |
| Total, serious adverse events | Placebo | 0 | 200 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dexmedetomidine vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT01528891
GET https://conductscience.org/api/trials/v1/NCT01528891/results?page=2