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| Name | Class |
|---|---|
| Hospira, now a wholly owned subsidiary of Pfizer | INDUSTRY |
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To Determine The Efficacy of a Rapid Bolus Injection of Dexmedetomidine on the Incidence of Emergence Agitation in Anesthetized Children and the Cardiovascular Profile of a Rapid Bolus Injection of Dexmedetomidine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Active Comparator | Dexmedetomidine |
|
| placebo | Placebo Comparator | Normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | 0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate (HR) | beats per minute (bpm) | 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). |
| Systolic Blood Pressure (SBP) | mmHg Two subjects with missing data points for SBP were necessarily eliminated from repeated measures analysis. | 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). |
| Diastolic Blood Pressure (DBP) | mmHg Three subjects with missing data points for DBP were necessarily eliminated from repeated measures analysis. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Emergence Agitation (EA) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter J Davis, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States | ||
| Childrens Hospital of Pittsburgh |
418 patients overall were enrolled in the study. Of these patients, 18 failed screening prior to randomization into either treatment arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexmedetomidine | Dexmedetomidine Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery |
| FG001 | Placebo | Normal saline equivalent volume Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexmedetomidine | Dexmedetomidine Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery Of the 200 patients in this treatment arm, 5 were totally excluded from analysis due to administration of medications that were not a part of the anesthetic protocol. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Heart Rate (HR) | beats per minute (bpm) | Heart rate values were compared between groups at each time point and within groups over time. | Posted | Mean | Standard Deviation | bpm | 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). |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexmedetomidine | Dexmedetomidine Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Desaturation with Atelectasis | Respiratory, thoracic and mediastinal disorders | The serious adverse event (SAE) was associated with a prolonged hospital stay. The investigators felt the SAE was unrelated to the study drug. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter J. Davis, MD | Children's Hospital of Pittsburgh of UPMC | 4126925260 | davispj@anes.upmc.edu |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Other |
|
| The highest PAED score for each patient within the first 30 minutes after waking up was recorded. |
| Pittsburgh |
| Pennsylvania |
| 15224 |
| United States |
| Placebo |
Normal saline equivalent volume Placebo Of the 200 patients in this treatment arm, 2 were totally excluded from analysis due to administration of medications that were not a part of the anesthetic protocol. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Incidence of Emergence Agitation (EA) | 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. | 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. | Posted | Number | percentage of patients with EA | The highest PAED score for each patient within the first 30 minutes after waking up was recorded. |
|
|
|
|
| Primary | Systolic Blood Pressure (SBP) | mmHg Two subjects with missing data points for SBP were necessarily eliminated from repeated measures analysis. | Systolic blood pressure values were compared between groups at each time point and within groups over time. | Posted | Mean | Standard Deviation | mmHg | 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). |
|
|
|
|
| Primary | Diastolic Blood Pressure (DBP) | mmHg Three subjects with missing data points for DBP were necessarily eliminated from repeated measures analysis. | Diastolic blood pressure values were compared between groups at each time point and within groups over time. | Posted | Mean | Standard Deviation | mmHg | 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). |
|
|
|
|
| 1 |
| 200 |
| 18 |
| 200 |
| EG001 | Placebo | Normal saline equivalent volume Placebo | 0 | 200 | 34 | 200 |
|
| Headache | General disorders |
|
| Congestion | General disorders |
|
| Bronchospasm | General disorders |
|
| Laryngospasm | General disorders |
|
| Tachypnea | General disorders |
|
| Stridor | General disorders |
|
| Hypercapnia | General disorders |
|
| Apnea | General disorders |
|
| Emesis | General disorders |
|
| Croupy Cough | General disorders |
|
| Desaturation | General disorders |
|
| Enuresis | General disorders |
|
| Bigeminal Premature Atrial Contractions | General disorders |
|
| Nausea | General disorders |
|
| Rigor | General disorders |
|
| Wheezing | General disorders |
|
| Pruritus | General disorders |
|
| Swelling | General disorders |
|
| Excess Secretions | General disorders |
|
| Intravenous Infiltration | General disorders |
|
| Bleeding | General disorders |
|
| Kinked intravenous catheter | General disorders |
|
| Poor oral intake | General disorders |
|
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| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| 2 min SBP |
|
| 3 min SBP |
|
| 4 min SBP |
|
| 5 min SBP |
|
| PACU SBP |
|
SBP values were compared against the baseline value within each group over time. |
| ANOVA |
| <0.01 |
P<0.01 for the following time points, as compared to the baseline value: 1 minute, 3 minutes, 4 minutes, and 5 minutes. P-values are adjusted for multiple comparisons. |
| 2-Sided |
| Superiority or Other |
| SBP values were compared against the baseline within each group over time. | ANOVA | <0.01 | P<0.01 for the following time points, as compared to the baseline value: 5 minutes and PACU. P-values were adjusted for multiple comparisons. | 2-Sided | Superiority or Other |
| 2 min DBP |
|
| 3 min DBP |
|
| 4 min DBP |
|
| 5 min DBP |
|
| PACU DBP |
|
DBP values were compared within each group against the baseline value.
| ANOVA |
| <0.01 |
P<0.01 for the following time points, as compared to baseline: 1 minute, 3 minutes, 4 minutes, 5 minutes, PACU. P-values were adjusted for multiple comparisons. |
| 2-Sided |
| Superiority or Other |
| DBP values were compared against the baseline value within each group over time. | ANOVA | <0.01 | P<0.01 for the following time points, as compared to baseline: 4 minutes, 5 minutes, PACU. P-values were adjusted for multiple comparisons. | 2-Sided | Superiority or Other |