Trial · NCT00875550
Study Evaluating Safety and Efficacy of Dexmedetomidine (DEX) in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit (PICU) Subjects
NCT00875550, Phase 3, Completed, Hospira, now a wholly owned subsidiary of Pfizer; results first posted 2014-10-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study Evaluating Safety and Efficacy of Dexmedetomidine (DEX) in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit (PICU) Subjects. Trials, record NCT00875550. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00875550
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Evaluating Safety and Efficacy of Dexmedetomidine (DEX) in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit (PICU) Subjects
- NCT number
- NCT00875550
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 175 participants, actual
- Lead sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
- Conditions
- Sedation
- Interventions
- Dexmedetomidine, Midazolam, Fentanyl, Morphine
- First posted
- 2009-04-03
- Last updated
- 2015-08-14
- Results first posted
- 2014-10-30
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects That do Not Require Rescue Midazolam (MDZ) for Sedation Based on Achieving and Maintaining a Target University of Michigan Sedation Scale (UMSS) Score of 1 to 3 While Intubated. | 6 to 24 hours | Clinical Score Level of Sedation 0 Awake/Alert 1. Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds. 2. Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation. 3. Deeply sedated: Deep sleep, arousable only with significant physical stimulation. 4. Unarousable |
| Secondary | Absolute Time on Study Drug That the Subject is in a UMSS Range of 1 to 3 While Intubated | 6 to 24 hours | |
| Secondary | Absolute Time on Study Drug That the Subject is Out of the Target Sedation Range (UMSS <1 or >3) While Intubated | 6 to 24 hours | |
| Secondary | Total Amount of Rescue Medication Required for Sedation and Analgesia While Intubated | 6 to 24 hours | |
| Secondary | Time to First Dose of Rescue Medication for Sedation and Analgesia | 6 to 24 hours | |
| Secondary | Time to Successful Extubation | 6 to 24 hours |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects That do Not Require Rescue Midazolam (MDZ) for Sedation Based on Achieving and Maintaining a Target University of Michigan Sedation Scale (UMSS) Score of 1 to 3 While Intubated. | 6 to 24 hours | Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours | Percentage of subjects | NUMBER |
| SECONDARY | Absolute Time on Study Drug That the Subject is in a UMSS Range of 1 to 3 While Intubated | 6 to 24 hours | Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours | Hours | MEDIAN |
| SECONDARY | Absolute Time on Study Drug That the Subject is Out of the Target Sedation Range (UMSS <1 or >3) While Intubated | 6 to 24 hours | Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours | hours | MEDIAN |
| SECONDARY | Total Amount of Rescue Medication Required for Sedation and Analgesia While Intubated | 6 to 24 hours | Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours | Milligram | MEAN |
| SECONDARY | Time to First Dose of Rescue Medication for Sedation and Analgesia | 6 to 24 hours | Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours | Hours | MEDIAN |
| SECONDARY | Time to Successful Extubation | 6 to 24 hours | Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours | Hours | MEDIAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects That do Not Require Rescue Midazolam (MDZ) for Sedation Based on Achieving and Maintaining a Target University of Michigan Sedation Scale (UMSS) Score of 1 to 3 While Intubated. | Dexmedetomidine Low Dose | 44.6 | Percentage of subjects | ||
| Percentage of Subjects That do Not Require Rescue Midazolam (MDZ) for Sedation Based on Achieving and Maintaining a Target University of Michigan Sedation Scale (UMSS) Score of 1 to 3 While Intubated. | Dexmedetomidine High Dose | 54.3 | Percentage of subjects | ||
| Absolute Time on Study Drug That the Subject is in a UMSS Range of 1 to 3 While Intubated | Dexmedetomidine Low Dose | 17.2 | Full Range 5 to 24 | Hours | |
| Absolute Time on Study Drug That the Subject is in a UMSS Range of 1 to 3 While Intubated | Dexmedetomidine High Dose | 17.3 | Full Range 2 to 24 | Hours | |
| Absolute Time on Study Drug That the Subject is Out of the Target Sedation Range (UMSS <1 or >3) While Intubated | Dexmedetomidine Low Dose | 1.0 | Full Range 0 to 10 | hours | |
| Absolute Time on Study Drug That the Subject is Out of the Target Sedation Range (UMSS <1 or >3) While Intubated | Dexmedetomidine High Dose | 0.7 | Full Range 0 to 14 | hours | |
| Total Amount of Rescue Medication Required for Sedation and Analgesia While Intubated | Dexmedetomidine Low Dose | Midazolam | 2.221 | Standard Deviation 4.6089 | Milligram |
| Total Amount of Rescue Medication Required for Sedation and Analgesia While Intubated | Dexmedetomidine High Dose | Midazolam | 1.241 | Standard Deviation 2.3052 | Milligram |
| Total Amount of Rescue Medication Required for Sedation and Analgesia While Intubated | Dexmedetomidine Low Dose | Fentanyl | 45.225 | Standard Deviation 83.7743 | Milligram |
| Total Amount of Rescue Medication Required for Sedation and Analgesia While Intubated | Dexmedetomidine High Dose | Fentanyl | 44.367 | Standard Deviation 112.13 | Milligram |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 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 Low Dose | 89 | |
| Overall Study | STARTED | Dexmedetomidine High Dose | 86 | |
| Overall Study | COMPLETED | Dexmedetomidine Low Dose | 77 | |
| Overall Study | COMPLETED | Dexmedetomidine High Dose | 76 | |
| Overall Study | NOT COMPLETED | Dexmedetomidine Low Dose | 12 | |
| Overall Study | NOT COMPLETED | Dexmedetomidine High Dose | 10 |
Source ClinicalTrials.gov
Adverse events188
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 | Anaemia | Blood and lymphatic system disorders | Dexmedetomidine Low Dose | 0 | 89 | |
| other | Anaemia | Blood and lymphatic system disorders | Dexmedetomidine High Dose | 2 | 86 | |
| other | Bradycardia | Cardiac disorders | Dexmedetomidine Low Dose | 2 | 89 | |
| other | Bradycardia | Cardiac disorders | Dexmedetomidine High Dose | 3 | 86 | |
| other | Extrasystoles | Cardiac disorders | Dexmedetomidine Low Dose | 1 | 89 | |
| other | Extrasystoles | Cardiac disorders | Dexmedetomidine High Dose | 0 | 86 | |
| other | Nodal rhythm | Cardiac disorders | Dexmedetomidine Low Dose | 1 | 89 | |
| other | Nodal rhythm | Cardiac disorders | Dexmedetomidine High Dose | 0 | 86 | |
| other | Tachycardia | Cardiac disorders | Dexmedetomidine Low Dose | 0 | 89 | |
| other | Tachycardia | Cardiac disorders | Dexmedetomidine High Dose | 2 | 86 |
1 to 10 of 188Source ClinicalTrials.gov
See all 188 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dexmedetomidine Low Dose | ||
| Total, all-cause mortality | Dexmedetomidine High Dose | ||
| Total, other adverse events | Dexmedetomidine Low Dose | 48 | 89 |
| Total, other adverse events | Dexmedetomidine High Dose | 43 | 86 |
| Total, serious adverse events | Dexmedetomidine Low Dose | 1 | 89 |
| Total, serious adverse events | Dexmedetomidine High Dose | 1 | 86 |
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 Low Dose vs Dexmedetomidine High Dose: 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/NCT00875550
GET https://conductscience.org/api/trials/v1/NCT00875550/events?page=2