Opioid & Steroid Use Following Tonsillectomy in Pediatric... | NCT04541147

Opioid & Steroid Use Following Tonsillectomy in Pediatric... | NCT04541147 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dexamethasone plus analgesics	Experimental	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).	Drug: Dexamethasone Drug: Analgesics
analgesics alone	Active Comparator	standardized course of analgesics (opioids/acetaminophen/NSAIDs)	Drug: Analgesics

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone	Drug	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.	Dexamethasone plus analgesics

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Opioid Use (Number of Doses)	Measured by medication log and units remaining.	4 weeks post-op
Average Pain Score	Measured by a visual analog scale, where 0 is no pain and 10 is worst possible pain.	14 days post-op

Measure	Description	Time Frame
Number of Participants With Post-operative Complications	Post-op re-admissions and emergency room visits.	30 days post-op

Contacts/Locations Module

Name	Affiliation	Role
Eileen Raynor, MD	Duke Health	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Duke University Medical Center and affiliated practices		Durham	North Carolina	27710	United States

Arm/Group Information

ID	Title	Description
FG000	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)
FG001	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)

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00016 subjects FG0018 subjects
COMPLETED		FG00014 subjects FG0017 subjects
NOT COMPLETED		FG0002 subjects FG0011 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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)

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

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

Opioid Use (Number of Doses)

Measured by medication log and units remaining.

Participants who completed the study.

Posted

Mean

Standard Deviation

doses

4 weeks post-op

ID	Title	Description
OG000	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)

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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)

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Emergency Room Visit	General disorders		Non-systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Eileen M. Raynor, MD	Duke University	919-613-4573		eileen.raynor@duke.edu

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Oct 5, 2023	Dec 4, 2024	Prot_SAP_000.pdf

Condition Browse Module

ID	Term
D010149	Pain, Postoperative

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Intervention Browse Module

ID	Term
D003907	Dexamethasone
D000700	Analgesics

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001 BG0010 BG0021
Not Hispanic or Latino	BG00012 BG0017 BG00219
Unknown or Not Reported	BG0003 BG0011 BG0024

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Race

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG0020
Asian	BG0000 BG0011 BG0021
Native Hawaiian or Other Pacific Islander	BG0000 BG0010 BG0020
Black or African American	BG0004 BG0012 BG0026
White	BG00012 BG0014 BG00216
More than one race	BG0000 BG0010 BG0020
Other	BG0000 BG0011 BG0021
Unknown or Not Reported	BG0000 BG0010 BG0020

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		t-test, 2 sided		0.16		Mean Difference (Final Values)	6.9	Standard Deviation	10.1	2-Sided	95	-2.9	16.7					Equivalence	Test if the number of doses in Dexamethasone Plus Analgesics group differs from that in Analgesics Alone group at a significance level of 0.05.

Primary

Average Pain Score

Measured by a visual analog scale, where 0 is no pain and 10 is worst possible pain.

Participants who completed the study.

Posted

Mean

Standard Deviation

score on a scale

14 days post-op

ID	Title	Description
OG000	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)
OG001	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)

Units	Counts
Participants	OG00014 OG0017

Title

Denominators

Categories

Title	Measurements
	OG0003.1± 1.7 OG0012.7± 0.8

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		t-test, 2 sided		0.56		Mean Difference (Final Values)	-0.4	Standard Deviation	1.4	2-Sided	95	-1.8	1.0					Equivalence	Test if the average pain score in Dexamethasone Plus Analgesics group differs from that in Analgesics Alone group at a significance level of 0.05.

Secondary

Number of Participants With Post-operative Complications

Post-op re-admissions and emergency room visits.

Participants who completed the study.

Posted

Count of Participants

Participants

30 days post-op

ID	Title	Description
OG000	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)
OG001	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)

Units	Counts
Participants	OG00014 OG0017

Title

Denominators

Categories

Title	Measurements
	OG0001 OG0011

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Fisher Exact		1.00		Risk Difference (RD)	0.07	Standard Error of the Mean	0.15	2-Sided	95	-0.22	0.36					Equivalence	Test if the Number of participants with post-operative complications in Dexamethasone Plus Analgesics group differs from that in Analgesics Alone group at a significance level of 0.05.