Opioid & Steroid Use Following Tonsillectomy in Pediatric Patients

NCT04541147 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: Pro00103025
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Number of Participants With Post-operative Complications

  30 days post-op

Study Arms (2)

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

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

Analgesics DRUG

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)

Dexamethasone plus analgesics; analgesics alone

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 4-17 years at time of surgery
• Scheduled for tonsillectomy or adenotonsillectomy surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center and affiliated practices

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone; Analgesics

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Results Point of Contact

• Title: Eileen M. Raynor, MD
• Organization: Duke University

eileen.raynor@duke.edu

919-613-4573

Study Officials

• Eileen Raynor, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 9, 2020
• Study Start: April 14, 2021
• Primary Completion: December 26, 2023
• Study Completion: December 26, 2023
• Last Updated: December 27, 2024
• Results First Posted: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)