Trial Outcomes & Findings for Precedex Special Investigation (in Pediatric Patients) (NCT NCT04040439)
NCT ID: NCT04040439
Last Updated: 2024-02-16
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
111 participants
Primary outcome timeframe
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).
Results posted on
2024-02-16
Participant Flow
Participant milestones
| Measure |
PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride)
Pediatric patients (45 weeks corrected gestational age to \<18 years old) administered Precedex for sedation during and after mechanical ventilation in the intensive care setting as indicated in the approved local product document were observed from the start of administration (hour 0) to the discharge from the intensive care unit (ICU) (up to Month 33, at the longest). The dosage can be adjusted as per physician's discretion.
\*IC=Informed Consent
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|---|---|
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Overall Study
STARTED
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111
|
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Overall Study
COMPLETED
|
98
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride)
Pediatric patients (45 weeks corrected gestational age to \<18 years old) administered Precedex for sedation during and after mechanical ventilation in the intensive care setting as indicated in the approved local product document were observed from the start of administration (hour 0) to the discharge from the intensive care unit (ICU) (up to Month 33, at the longest). The dosage can be adjusted as per physician's discretion.
\*IC=Informed Consent
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|---|---|
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Overall Study
Invalid registration
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11
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Overall Study
No IC* on publication of study results
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2
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride)
n=98 Participants
Pediatric patients (45 weeks corrected gestational age to \<18 years old) administered Precedex for sedation during and after mechanical ventilation in the intensive care setting as indicated in the approved local product document were observed from the start of administration (hour 0) to the discharge from the intensive care unit (ICU) (up to Month 33, at the longest). The dosage can be adjusted as per physician's discretion.
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|---|---|
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Age, Customized
≥45 weeks of corrected gestational age to <12 months of age
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35 Participants
n=98 Participants
|
|
Age, Customized
≥12 to <24 months of age
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14 Participants
n=98 Participants
|
|
Age, Customized
≥2 to <6 years
|
27 Participants
n=98 Participants
|
|
Age, Customized
≥6 to <18 years
|
22 Participants
n=98 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=98 Participants
|
|
Sex: Female, Male
Male
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52 Participants
n=98 Participants
|
PRIMARY outcome
Timeframe: 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).Population: 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.
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.
Outcome measures
| Measure |
PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride)
n=98 Participants
Pediatric patients (45 weeks corrected gestational age to \<18 years old) administered Precedex for sedation during and after mechanical ventilation in the intensive care setting as indicated in the approved local product document were observed from the start of administration (hour 0) to the discharge from the intensive care unit (ICU) (up to Month 33, at the longest). The dosage can be adjusted as per physician's discretion.
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|---|---|
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Number of Participants With Adverse Drug Reactions
ADR
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9 Participants
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Number of Participants With Adverse Drug Reactions
Serious ADR
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2 Participants
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SECONDARY outcome
Timeframe: At the end of administration of Precedex (up to Month 33, at the longest)Population: 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.
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.
Outcome measures
| Measure |
PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride)
n=76 Participants
Pediatric patients (45 weeks corrected gestational age to \<18 years old) administered Precedex for sedation during and after mechanical ventilation in the intensive care setting as indicated in the approved local product document were observed from the start of administration (hour 0) to the discharge from the intensive care unit (ICU) (up to Month 33, at the longest). The dosage can be adjusted as per physician's discretion.
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|---|---|
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Percentage of Participants Who Were Evaluated as Effective (Responders) by the Physician
Effective
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100.0 Percentage of participants
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Percentage of Participants Who Were Evaluated as Effective (Responders) by the Physician
Not effective
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0.0 Percentage of participants
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Percentage of Participants Who Were Evaluated as Effective (Responders) by the Physician
Indeterminate
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0.0 Percentage of participants
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Adverse Events
PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride)
Serious events: 4 serious events
Other events: 8 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride)
n=98 participants at risk
Pediatric patients (45 weeks corrected gestational age to \<18 years old) administered Precedex for sedation during and after mechanical ventilation in the intensive care setting as indicated in the approved local product document were observed from the start of administration (hour 0) to the discharge from the intensive care unit (ICU) (up to Month 33, at the longest). The dosage can be adjusted as per physician's discretion.
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|---|---|
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Cardiac disorders
Cardiac arrest
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2.0%
2/98 • 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 frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
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Gastrointestinal disorders
Multiple organ dysfunction syndrome
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1.0%
1/98 • 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 frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
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Nervous system disorders
Status epilepticus
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1.0%
1/98 • 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 frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
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Respiratory, thoracic and mediastinal disorders
Asthma
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1.0%
1/98 • 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 frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
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Other adverse events
| Measure |
PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride)
n=98 participants at risk
Pediatric patients (45 weeks corrected gestational age to \<18 years old) administered Precedex for sedation during and after mechanical ventilation in the intensive care setting as indicated in the approved local product document were observed from the start of administration (hour 0) to the discharge from the intensive care unit (ICU) (up to Month 33, at the longest). The dosage can be adjusted as per physician's discretion.
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|---|---|
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Cardiac disorders
Bradycardia
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2.0%
2/98 • 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 frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
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Cardiac disorders
Junctional ectopic tachycardia
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1.0%
1/98 • 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 frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
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General disorders
Pyrexia
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1.0%
1/98 • 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 frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
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Investigations
Blood pressure decreased
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2.0%
2/98 • 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 frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
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|
Investigations
Oxygen saturation decreased
|
1.0%
1/98 • 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 frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
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Respiratory, thoracic and mediastinal disorders
Bradypnoea
|
1.0%
1/98 • 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 frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER