Pediatric Adenotonsillectomy, Post Operative Analgesia
Conditions
Keywords
Adenotonsillectomy, Postoperative analgesia, Pediatrics
Brief summary
The hypothesis of this study is that the administration of an intra-operative dose of dexmedetomidine will result in adequate analgesia without respiratory depression thereby resulting in an early discharge from the post anesthetic care unit following adenotonsillectomy.
Detailed description
Dexmedetomidine, an alpha 2 agonist provides some analgesia without respiratory depression. Children undergoing tonsillectomy and adenoidectomy occasionally have episodes of respiratory obstruction in the recovery room following administration of opioids. As dexmedetomidine provides some analgesia without respiratory depression,an intra-operative dose of dexmedetomidine may provide adequate analgesia without significant side effects thereby allowing for quick post operative recovery.
Interventions
DRUGDexmedetomidine 0.75 mcg/kg
Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia.
DRUGMorphine 50 mcg/kg
Single intra-operative administration of morphine 50 mcg/kg over 10 minutes for analgesia
DRUGMorphine 100 mcg/kg
Single intra-operative dose of morphine 100 mcg/kg over 10 minutes for analgesia
DRUGDexmedetomidine 1 mcg/kg
Single intra-operative administration of dexmedetomidine 1 mcg/kg over 10 minutes for analgesia
Sponsors
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Children between ages 3 and 17 years with American Society of Anesthesiology classification 1 or 2.
Exclusion criteria
* Children less than 3 years * Children with uncorrected cardiac lesions * Children with heart block or liver impairment * Children with American Society of Anesthesiology Class 3 or 4.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of Post-Operative Rescue Morphine Required for Analgesia | From admission to discharge from PACU, up to 1 hour |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Rescue Doses Needed by Participants | From admission to discharge from PACU, up to 1 hour | Subjects with a Children's Hospital of Eastern Ontario Pain Scale score greater than 8 received rescue morphine doses of 25 ug/kg IV at 10-minute intervals until the score was less than 8. Minimum and Maximum values: minimum score: 4 & maximum score: 13. The higher the score ( \> 8), the greater the pain appreciated by the patient. |
| Duration of Oxygen Supplementation | From admission to PACU until room air saturations greater than or equal to 95% for 5 minutes | The subjects were then transported to the PACU with supplemental oxygen. Oxygen administration was continued after extubation until the patient was awake and could sustain room air saturations greater than 95% for 5 minutes. Duration of oxygen requirement was recorded as the time from tracheal extubation to cessation of oxygen supplementation in the PACU. |
| Time to PACU Discharge Readiness | From admission to discharge from PACU, no time limit | Patients were considered ready for discharge from the PACU when they attained an Aldrete score of 9 or more and were free from pain, nausea, and vomiting. Aldrete score ranges form 0 to 10 and patients greater than 8 are deemed satisfactory for discharge from the PACU |
| Number of Participants With Emergence Agitation | From admission to discharge from PACU, no time limit | Patients in the PACU who were crying, restless, disoriented, unresponsive to the parent's voice, with non-purposeful thrashing movements requiring additional personnel to prevent bodily harm, and inconsolable even after parental presence, rescue analgesia and additional measures of comfort were considered to have emergence agitation. |
| Number of Participants With Postoperative Complications | From admission to discharge from PACU, up to 1 hour | Post-operative complications including emesis, prolonged oxygen requirement or post- tonsillectomy bleed assessed up to 1 hour in PACU |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexmedetomidine 0.75 mcg/kg Intraoperative administration for analgesia.
Dexmedetomidine 0.75 mcg/kg: Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia. | 26 |
| Dexmedetomidine 1mcg/kg Intra-operative administration of dexmedetomidine 1 mcg/kg for analgesia
Dexmedetomidine 1 mcg/kg: Single intra-operative administration of dexmedetomidine 1 mcg/kg over 10 minutes for analgesia | 27 |
| Morphine 50 mcg/kg Intra-operative administration of morphine 50 mcg/kg for analgesia
Morphine 50 mcg/kg: Single intra-operative administration of morphine 50 mcg/kg over 10 minutes for analgesia | 30 |
| Morphine 100mcg/kg Intra-operative administration of morphine 100mcg/kg for analgesia
Morphine 100 mcg/kg: Single intra-operative dose of morphine 100 mcg/kg over 10 minutes for analgesia | 26 |
| Total | 109 |
Baseline characteristics
| Characteristic | Dexmedetomidine 0.75 mcg/kg | Dexmedetomidine 1mcg/kg | Morphine 50 mcg/kg | Morphine 100mcg/kg | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 26 Participants | 27 Participants | 30 Participants | 26 Participants | 109 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Duration of Anesthesia | 48.2 minutes STANDARD_DEVIATION 19.3 | 44.7 minutes STANDARD_DEVIATION 10.8 | 43.3 minutes STANDARD_DEVIATION 9.7 | 49.6 minutes STANDARD_DEVIATION 13.3 | 46.3 minutes STANDARD_DEVIATION 13.7 |
| Duration of Surgery | 22.0 minutes STANDARD_DEVIATION 8.4 | 21.3 minutes STANDARD_DEVIATION 9.7 | 22.8 minutes STANDARD_DEVIATION 7.6 | 26.0 minutes STANDARD_DEVIATION 9.5 | 23.0 minutes STANDARD_DEVIATION 8.9 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Region of Enrollment United States | 26 participants | 27 participants | 30 participants | 26 participants | 109 participants |
| Sex: Female, Male Female | 18 Participants | 16 Participants | 15 Participants | 16 Participants | 65 Participants |
| Sex: Female, Male Male | 8 Participants | 11 Participants | 15 Participants | 10 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 27 | 0 / 30 | 0 / 26 |
| other Total, other adverse events | 0 / 26 | 0 / 27 | 0 / 30 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 27 | 0 / 30 | 0 / 26 |
Outcome results
Primary
Amount of Post-Operative Rescue Morphine Required for Analgesia
Time frame: From admission to discharge from PACU, up to 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine 0.75 mcg/kg | Amount of Post-Operative Rescue Morphine Required for Analgesia | 45.2 ug/kg | Standard Deviation 30.8 |
| Dexmedetomidine 1mcg/kg | Amount of Post-Operative Rescue Morphine Required for Analgesia | 37.0 ug/kg | Standard Deviation 25.4 |
| Morphine 50 mcg/kg | Amount of Post-Operative Rescue Morphine Required for Analgesia | 43.3 ug/kg | Standard Deviation 23.6 |
| Morphine 100mcg/kg | Amount of Post-Operative Rescue Morphine Required for Analgesia | 36.5 ug/kg | Standard Deviation 31 |
Secondary
Duration of Oxygen Supplementation
The subjects were then transported to the PACU with supplemental oxygen. Oxygen administration was continued after extubation until the patient was awake and could sustain room air saturations greater than 95% for 5 minutes. Duration of oxygen requirement was recorded as the time from tracheal extubation to cessation of oxygen supplementation in the PACU.
Time frame: From admission to PACU until room air saturations greater than or equal to 95% for 5 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine 0.75 mcg/kg | Duration of Oxygen Supplementation | 17 minutes | Standard Deviation 11 |
| Dexmedetomidine 1mcg/kg | Duration of Oxygen Supplementation | 19 minutes | Standard Deviation 12 |
| Morphine 50 mcg/kg | Duration of Oxygen Supplementation | 20 minutes | Standard Deviation 19 |
| Morphine 100mcg/kg | Duration of Oxygen Supplementation | 18 minutes | Standard Deviation 14 |
Secondary
Morphine Rescue Doses Needed by Participants
Subjects with a Children's Hospital of Eastern Ontario Pain Scale score greater than 8 received rescue morphine doses of 25 ug/kg IV at 10-minute intervals until the score was less than 8. Minimum and Maximum values: minimum score: 4 & maximum score: 13. The higher the score ( \> 8), the greater the pain appreciated by the patient.
Time frame: From admission to discharge from PACU, up to 1 hour
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexmedetomidine 0.75 mcg/kg | Morphine Rescue Doses Needed by Participants | 1 dose | 2 Participants |
| Dexmedetomidine 0.75 mcg/kg | Morphine Rescue Doses Needed by Participants | >1 dose | 18 Participants |
| Dexmedetomidine 0.75 mcg/kg | Morphine Rescue Doses Needed by Participants | 0 dose | 6 Participants |
| Dexmedetomidine 1mcg/kg | Morphine Rescue Doses Needed by Participants | 0 dose | 3 Participants |
| Dexmedetomidine 1mcg/kg | Morphine Rescue Doses Needed by Participants | >1 dose | 10 Participants |
| Dexmedetomidine 1mcg/kg | Morphine Rescue Doses Needed by Participants | 1 dose | 14 Participants |
| Morphine 50 mcg/kg | Morphine Rescue Doses Needed by Participants | 1 dose | 13 Participants |
| Morphine 50 mcg/kg | Morphine Rescue Doses Needed by Participants | 0 dose | 1 Participants |
| Morphine 50 mcg/kg | Morphine Rescue Doses Needed by Participants | >1 dose | 16 Participants |
| Morphine 100mcg/kg | Morphine Rescue Doses Needed by Participants | 0 dose | 4 Participants |
| Morphine 100mcg/kg | Morphine Rescue Doses Needed by Participants | >1 dose | 8 Participants |
| Morphine 100mcg/kg | Morphine Rescue Doses Needed by Participants | 1 dose | 14 Participants |
Secondary
Number of Participants With Emergence Agitation
Patients in the PACU who were crying, restless, disoriented, unresponsive to the parent's voice, with non-purposeful thrashing movements requiring additional personnel to prevent bodily harm, and inconsolable even after parental presence, rescue analgesia and additional measures of comfort were considered to have emergence agitation.
Time frame: From admission to discharge from PACU, no time limit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexmedetomidine 0.75 mcg/kg | Number of Participants With Emergence Agitation | 5 Participants |
| Dexmedetomidine 1mcg/kg | Number of Participants With Emergence Agitation | 4 Participants |
| Morphine 50 mcg/kg | Number of Participants With Emergence Agitation | 4 Participants |
| Morphine 100mcg/kg | Number of Participants With Emergence Agitation | 1 Participants |
Secondary
Number of Participants With Postoperative Complications
Post-operative complications including emesis, prolonged oxygen requirement or post- tonsillectomy bleed assessed up to 1 hour in PACU
Time frame: From admission to discharge from PACU, up to 1 hour
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexmedetomidine 0.75 mcg/kg | Number of Participants With Postoperative Complications | Vomiting | 0 Participants |
| Dexmedetomidine 0.75 mcg/kg | Number of Participants With Postoperative Complications | Nausea | 2 Participants |
| Dexmedetomidine 1mcg/kg | Number of Participants With Postoperative Complications | Vomiting | 0 Participants |
| Dexmedetomidine 1mcg/kg | Number of Participants With Postoperative Complications | Nausea | 0 Participants |
| Morphine 50 mcg/kg | Number of Participants With Postoperative Complications | Nausea | 0 Participants |
| Morphine 50 mcg/kg | Number of Participants With Postoperative Complications | Vomiting | 0 Participants |
| Morphine 100mcg/kg | Number of Participants With Postoperative Complications | Nausea | 3 Participants |
| Morphine 100mcg/kg | Number of Participants With Postoperative Complications | Vomiting | 2 Participants |
Secondary
Time to PACU Discharge Readiness
Patients were considered ready for discharge from the PACU when they attained an Aldrete score of 9 or more and were free from pain, nausea, and vomiting. Aldrete score ranges form 0 to 10 and patients greater than 8 are deemed satisfactory for discharge from the PACU
Time frame: From admission to discharge from PACU, no time limit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine 0.75 mcg/kg | Time to PACU Discharge Readiness | 115 minutes | Standard Deviation 0.04 |
| Dexmedetomidine 1mcg/kg | Time to PACU Discharge Readiness | 116 minutes | Standard Deviation 0.03 |
| Morphine 50 mcg/kg | Time to PACU Discharge Readiness | 117 minutes | Standard Deviation 0.03 |
| Morphine 100mcg/kg | Time to PACU Discharge Readiness | 122 minutes | Standard Deviation 0.06 |