Tonsillectomy
Conditions
Keywords
tonsillectomy, emergence agitation
Brief summary
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.
Interventions
DRUGDexmedetomidine
0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery
OTHERPlacebo
Sponsors
Hospira, now a wholly owned subsidiary of Pfizer
Peter Davis
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* children undergoing tonsillectomy with and without adenoidectomy and myringotomy and tube insertion * ASA 1,2,3 * females who have started menses but have a negative urine pregnancy test
Exclusion criteria
* patients with known dysrhythmias, * not recovering in the ICU * developmental delay, * autism communication disorder * bleeding disorder * PI discretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
418 patients overall were enrolled in the study. Of these patients, 18 failed screening prior to randomization into either treatment arm.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 195 |
| 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. | 198 |
| Total | 393 |
Baseline characteristics
| Characteristic | Placebo | Dexmedetomidine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 198 Participants | 195 Participants | 393 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 5.8 years STANDARD_DEVIATION 1.6 | 6.1 years STANDARD_DEVIATION 1.6 | 6.0 years STANDARD_DEVIATION 1.6 |
| Region of Enrollment United States | 198 participants | 195 participants | 393 participants |
| Sex: Female, Male Female | 97 Participants | 96 Participants | 193 Participants |
| Sex: Female, Male Male | 101 Participants | 99 Participants | 200 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 200 | 34 / 200 |
| serious Total, serious adverse events | 1 / 200 | 0 / 200 |
Outcome results
Primary
Diastolic Blood Pressure (DBP)
mmHg Three subjects with missing data points for DBP were necessarily eliminated from repeated measures analysis.
Time frame: 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).
Population: Diastolic blood pressure values were compared between groups at each time point and within groups over time.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexmedetomidine | Diastolic Blood Pressure (DBP) | 2 min DBP | 48 mmHg | Standard Deviation 9 |
| Dexmedetomidine | Diastolic Blood Pressure (DBP) | 4 min DBP | 44 mmHg | Standard Deviation 8 |
| Dexmedetomidine | Diastolic Blood Pressure (DBP) | 1 min DBP | 52 mmHg | Standard Deviation 10 |
| Dexmedetomidine | Diastolic Blood Pressure (DBP) | 5 min DBP | 43 mmHg | Standard Deviation 8 |
| Dexmedetomidine | Diastolic Blood Pressure (DBP) | 3 min DBP | 45 mmHg | Standard Deviation 8 |
| Dexmedetomidine | Diastolic Blood Pressure (DBP) | PACU DBP | 50 mmHg | Standard Deviation 7 |
| Dexmedetomidine | Diastolic Blood Pressure (DBP) | Baseline DBP | 47 mmHg | Standard Deviation 9 |
| Placebo | Diastolic Blood Pressure (DBP) | PACU DBP | 55 mmHg | Standard Deviation 11 |
| Placebo | Diastolic Blood Pressure (DBP) | Baseline DBP | 47 mmHg | Standard Deviation 9 |
| Placebo | Diastolic Blood Pressure (DBP) | 1 min DBP | 47 mmHg | Standard Deviation 9 |
| Placebo | Diastolic Blood Pressure (DBP) | 2 min DBP | 47 mmHg | Standard Deviation 8 |
| Placebo | Diastolic Blood Pressure (DBP) | 3 min DBP | 46 mmHg | Standard Deviation 8 |
| Placebo | Diastolic Blood Pressure (DBP) | 4 min DBP | 45 mmHg | Standard Deviation 9 |
| Placebo | Diastolic Blood Pressure (DBP) | 5 min DBP | 45 mmHg | Standard Deviation 8 |
Comparison: DBP values were compared between groups at each time point.p-value: <0.01t-test, 2 sided
Comparison: DBP values were compared within each group against the baseline value.p-value: <0.01ANOVA
Comparison: DBP values were compared against the baseline value within each group over time.p-value: <0.01ANOVA
Primary
Heart Rate (HR)
beats per minute (bpm)
Time frame: 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).
Population: Heart rate values were compared between groups at each time point and within groups over time.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexmedetomidine | Heart Rate (HR) | 2 min HR | 104 bpm | Standard Deviation 16 |
| Dexmedetomidine | Heart Rate (HR) | 4 min HR | 105 bpm | Standard Deviation 15 |
| Dexmedetomidine | Heart Rate (HR) | 1 min HR | 107 bpm | Standard Deviation 18 |
| Dexmedetomidine | Heart Rate (HR) | 5 min HR | 105 bpm | Standard Deviation 15 |
| Dexmedetomidine | Heart Rate (HR) | 3 min HR | 105 bpm | Standard Deviation 14 |
| Dexmedetomidine | Heart Rate (HR) | PACU HR | 94 bpm | Standard Deviation 13 |
| Dexmedetomidine | Heart Rate (HR) | Baseline HR | 120 bpm | Standard Deviation 16 |
| Placebo | Heart Rate (HR) | PACU HR | 108 bpm | Standard Deviation 16 |
| Placebo | Heart Rate (HR) | Baseline HR | 121 bpm | Standard Deviation 16 |
| Placebo | Heart Rate (HR) | 1 min HR | 121 bpm | Standard Deviation 16 |
| Placebo | Heart Rate (HR) | 2 min HR | 120 bpm | Standard Deviation 15 |
| Placebo | Heart Rate (HR) | 3 min HR | 119 bpm | Standard Deviation 15 |
| Placebo | Heart Rate (HR) | 4 min HR | 118 bpm | Standard Deviation 15 |
| Placebo | Heart Rate (HR) | 5 min HR | 117 bpm | Standard Deviation 15 |
Comparison: Heart rate values at each time point were compared between groups.p-value: <0.01t-test, 2 sided
Comparison: Heart rate values were compared over time against the baseline value.p-value: <0.01ANOVA
Comparison: Heart rate values were compared over time against the baseline value.p-value: <0.01ANOVA
Primary
Systolic Blood Pressure (SBP)
mmHg Two subjects with missing data points for SBP were necessarily eliminated from repeated measures analysis.
Time frame: 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).
Population: Systolic blood pressure values were compared between groups at each time point and within groups over time.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexmedetomidine | Systolic Blood Pressure (SBP) | 2 min SBP | 99 mmHg | Standard Deviation 14 |
| Dexmedetomidine | Systolic Blood Pressure (SBP) | 4 min SBP | 93 mmHg | Standard Deviation 13 |
| Dexmedetomidine | Systolic Blood Pressure (SBP) | 1 min SBP | 104 mmHg | Standard Deviation 16 |
| Dexmedetomidine | Systolic Blood Pressure (SBP) | 5 min SBP | 92 mmHg | Standard Deviation 13 |
| Dexmedetomidine | Systolic Blood Pressure (SBP) | 3 min SBP | 95 mmHg | Standard Deviation 13 |
| Dexmedetomidine | Systolic Blood Pressure (SBP) | PACU SBP | 97 mmHg | Standard Deviation 12 |
| Dexmedetomidine | Systolic Blood Pressure (SBP) | Baseline SBP | 99 mmHg | Standard Deviation 16 |
| Placebo | Systolic Blood Pressure (SBP) | PACU SBP | 105 mmHg | Standard Deviation 17 |
| Placebo | Systolic Blood Pressure (SBP) | Baseline SBP | 99 mmHg | Standard Deviation 16 |
| Placebo | Systolic Blood Pressure (SBP) | 1 min SBP | 100 mmHg | Standard Deviation 15 |
| Placebo | Systolic Blood Pressure (SBP) | 2 min SBP | 99 mmHg | Standard Deviation 14 |
| Placebo | Systolic Blood Pressure (SBP) | 3 min SBP | 98 mmHg | Standard Deviation 14 |
| Placebo | Systolic Blood Pressure (SBP) | 4 min SBP | 97 mmHg | Standard Deviation 15 |
| Placebo | Systolic Blood Pressure (SBP) | 5 min SBP | 96 mmHg | Standard Deviation 15 |
Comparison: Systolic blood pressure values were compared between groups at each time point.p-value: <0.01t-test, 2 sided
Comparison: SBP values were compared against the baseline value within each group over time.p-value: <0.01ANOVA
Comparison: SBP values were compared against the baseline within each group over time.p-value: <0.01ANOVA
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.
Time frame: The highest PAED score for each patient within the first 30 minutes after waking up was recorded.
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexmedetomidine | Incidence of Emergence Agitation (EA) | EA using PAED >10 threshold | 36 percentage of patients with EA |
| Dexmedetomidine | Incidence of Emergence Agitation (EA) | EA using PAED >12 threshold | 30 percentage of patients with EA |
| Placebo | Incidence of Emergence Agitation (EA) | EA using PAED >10 threshold | 66 percentage of patients with EA |
| Placebo | Incidence of Emergence Agitation (EA) | EA using PAED >12 threshold | 61 percentage of patients with EA |
Comparison: The incidence of agitated patients in each group was compared.p-value: <0.0001Fisher Exact