Trial · NCT04040439
Precedex Special Investigation (in Pediatric Patients)
NCT04040439, Completed, Pfizer; results first posted 2024-02-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Precedex Special Investigation (in Pediatric Patients). Trials, record NCT04040439. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04040439
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Precedex Special Investigation (in Pediatric Patients)
- NCT number
- NCT04040439
- Status
- Completed
- Enrollment
- 111 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Sedation
- Interventions
- Dexmedetomidine Hydrochloride
- First posted
- 2019-07-31
- Last updated
- 2024-02-16
- Results first posted
- 2024-02-16
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Drug Reactions | From the start of administration of Precedex (hour 0) to the discharge from the intensive care unit (ICU) (up to Month 33, at the longest). | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Precedex in a participant who received Precedex. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Precedex was assessed by the physician. |
| Secondary | Percentage of Participants Who Were Evaluated as Effective (Responders) by the Physician | At the end of administration of Precedex (up to Month 33, at the longest) | Overall effectiveness of Precedex was evaluated at the end of Precedex administration by the physician. Clinical effectiveness was evaluated as effective, not effective, or indeterminate by the physician. Clinical effectiveness proportion was defined as the proportion of responders divided by the total number of responders and non-responders. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Drug Reactions | From the start of administration of Precedex (hour 0) to the discharge from the intensive care unit (ICU) (up to Month 33, at the longest). | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Precedex at least once. Participants with invalid registration or without informed consent were excluded. | Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Were Evaluated as Effective (Responders) by the Physician | At the end of administration of Precedex (up to Month 33, at the longest) | The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation by the physician at the end of Precedex administration. Participants who received Precedex for an out-of-scope indication, or those who received inadequate duration or dose of Precedex were excluded. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Drug Reactions | PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride) | ADR | 9 | Participants | |
| Number of Participants With Adverse Drug Reactions | PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride) | Serious ADR | 2 | Participants | |
| Percentage of Participants Who Were Evaluated as Effective (Responders) by the Physician | PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride) | Effective | 100.0 | Percentage of participants | |
| Percentage of Participants Who Were Evaluated as Effective (Responders) by the Physician | PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride) | Not effective | 0.0 | Percentage of participants | |
| Percentage of Participants Who Were Evaluated as Effective (Responders) by the Physician | PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride) | Indeterminate | 0.0 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride) | 111 | |
| Overall Study | COMPLETED | PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride) | 98 | |
| Overall Study | NOT COMPLETED | PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride) | 13 |
Source ClinicalTrials.gov
Adverse events10
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 | Bradycardia | Cardiac disorders | PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride) | 2 | 98 | |
| other | Junctional ectopic tachycardia | Cardiac disorders | PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride) | 1 | 98 | |
| other | Pyrexia | General disorders | PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride) | 1 | 98 | |
| other | Blood pressure decreased | Investigations | PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride) | 2 | 98 | |
| other | Oxygen saturation decreased | Investigations | PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride) | 1 | 98 | |
| other | Bradypnoea | Respiratory, thoracic and mediastinal disorders | PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride) | 1 | 98 | |
| serious | Cardiac arrest | Cardiac disorders | PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride) | 2 | 98 | |
| serious | Multiple organ dysfunction syndrome | Gastrointestinal disorders | PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride) | 1 | 98 | |
| serious | Status epilepticus | Nervous system disorders | PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride) | 1 | 98 | |
| serious | Asthma | Respiratory, thoracic and mediastinal disorders | PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride) | 1 | 98 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride) | 1 | 98 |
| Total, other adverse events | PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride) | 8 | 98 |
| Total, serious adverse events | PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride) | 4 | 98 |
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 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/NCT04040439
GET https://conductscience.org/api/trials/v1/NCT04040439/registered