Pain, Postoperative
Conditions
Brief summary
The purpose of this study is to determine if a post-operative course of oral dexamethasone affects opioid usage in pediatric patients undergoing tonsillectomy. Patients who are scheduled to undergo tonsillectomy or adenotonsillectomy are randomized to receive either 1) a post-operative steroid course of oral dexamethasone in addition opioids, acetaminophen,NSAIDs or 2) opioids/acetaminophen/NSAIDS alone. All drugs are prescribed per approved FDA labeling. Children between the ages of 4-17 will be considered for enrollment. Participants (or with the aid of parents/legal guardian for subjects unable to complete on their own) will complete a diary twice a day to record pain medication administration and visual pain scale. Remaining steroid and opioid medication will be measured at the routine post-operative appointment that occurs 4 - 6 weeks following surgery.
Interventions
DRUGDexamethasone
dexamethasone solution or tablet (depending on age of patient) at 0.5mg/kg/day max of 8mg/day, administered on post-operative days 1,3,5,7.
DRUGAnalgesics
standardization of post-operative analgesics (narcotics and non-narcotic medication). * Oxycodone solution or tablet (depending on age of patient) at 0.05-0.1 mg/kg/dose every 6hrs; max 5mg (obese/OSA); prescribe 30 doses * Acetaminophen 10-15 mg/kg/dose every 6 hours; max 500mg per dose; prescribe 56 doses (over the counter medication) * Ibuprofen 5-10 mg/kg/dose every 6 hours; max 200 mg/dose; prescribe 56 doses (over the counter medication)
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Age 4-17 years at time of surgery * Scheduled for tonsillectomy or adenotonsillectomy surgery
Exclusion criteria
* Prior history of intracapsular tonsillectomy * Previous diagnoses of Down Syndrome or developmental delay * Presence of gastrostomy (g) tube * A contraindication to steroids or steroid usage within 30 days prior to surgery including diabetes, allergy to steroid, already on chronic steroid, immune deficiency * Active infection or concurrent operative procedures at the time of surgery * Unable to read or speak English * Pregnant or breastfeeding females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Use (Number of Doses) | 4 weeks post-op | Measured by medication log and units remaining. |
| Average Pain Score | 14 days post-op | Measured by a visual analog scale, where 0 is no pain and 10 is worst possible pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Post-operative Complications | 30 days post-op | Post-op re-admissions and emergency room visits. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexamethasone Plus Analgesics oral dexamethasone of 0.5mg/kg/day (max of 8mg/day), administered on post-operative days 1,3,5,7 in addition to standardized course of analgesics (opioids/acetaminophen/NSAIDs).
Dexamethasone: dexamethasone solution or tablet (depending on age of patient) at 0.5mg/kg/day max of 8mg/day, administered on post-operative days 1,3,5,7.
Analgesics: standardization of post-operative analgesics (narcotics and non-narcotic medication).
* Oxycodone solution or tablet (depending on age of patient) at 0.05-0.1 mg/kg/dose every 6hrs; max 5mg (obese/OSA); prescribe 30 doses
* Acetaminophen 10-15 mg/kg/dose every 6 hours; max 500mg per dose; prescribe 56 doses (over the counter medication)
* Ibuprofen 5-10 mg/kg/dose every 6 hours; max 200 mg/dose; prescribe 56 doses (over the counter medication) | 16 |
| Analgesics Alone standardized course of analgesics (opioids/acetaminophen/NSAIDs)
Analgesics: standardization of post-operative analgesics (narcotics and non-narcotic medication).
* Oxycodone solution or tablet (depending on age of patient) at 0.05-0.1 mg/kg/dose every 6hrs; max 5mg (obese/OSA); prescribe 30 doses
* Acetaminophen 10-15 mg/kg/dose every 6 hours; max 500mg per dose; prescribe 56 doses (over the counter medication)
* Ibuprofen 5-10 mg/kg/dose every 6 hours; max 200 mg/dose; prescribe 56 doses (over the counter medication) | 8 |
| Total | 24 |
Baseline characteristics
| Characteristic | Dexamethasone Plus Analgesics | Total | Analgesics Alone |
|---|---|---|---|
| Age, Continuous | 8.8 years STANDARD_DEVIATION 4.2 | 8.5 years STANDARD_DEVIATION 3.7 | 7.8 years STANDARD_DEVIATION 2.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 19 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Black or African American | 4 Participants | 6 Participants | 2 Participants |
| Race/Ethnicity, Customized Race More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race White | 12 Participants | 16 Participants | 4 Participants |
| Region of Enrollment United States | 16 Participants | 24 Participants | 8 Participants |
| Sex: Female, Male Female | 8 Participants | 13 Participants | 5 Participants |
| Sex: Female, Male Male | 8 Participants | 11 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 8 |
| other Total, other adverse events | 12 / 16 | 6 / 8 |
| serious Total, serious adverse events | 0 / 16 | 0 / 8 |
Outcome results
Primary
Average Pain Score
Measured by a visual analog scale, where 0 is no pain and 10 is worst possible pain.
Time frame: 14 days post-op
Population: Participants who completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexamethasone Plus Analgesics | Average Pain Score | 3.1 score on a scale | Standard Deviation 1.7 |
| Analgesics Alone | Average Pain Score | 2.7 score on a scale | Standard Deviation 0.8 |
p-value: 0.5695% CI: [-1.8, 1]t-test, 2 sided
Primary
Opioid Use (Number of Doses)
Measured by medication log and units remaining.
Time frame: 4 weeks post-op
Population: Participants who completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexamethasone Plus Analgesics | Opioid Use (Number of Doses) | 11.5 doses | Standard Deviation 10.8 |
| Analgesics Alone | Opioid Use (Number of Doses) | 18.4 doses | Standard Deviation 8.4 |
p-value: 0.1695% CI: [-2.9, 16.7]t-test, 2 sided
Secondary
Number of Participants With Post-operative Complications
Post-op re-admissions and emergency room visits.
Time frame: 30 days post-op
Population: Participants who completed the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexamethasone Plus Analgesics | Number of Participants With Post-operative Complications | 1 Participants |
| Analgesics Alone | Number of Participants With Post-operative Complications | 1 Participants |
p-value: 195% CI: [-0.22, 0.36]Fisher Exact