Using steroids to manage pain after tonsil surgery
Randomized, Controlled Trial of Post-operative Steroids and Pain Control After Tonsillectomy
This study tests if giving a single dose of steroids can help reduce pain and the need for stronger pain medications in children aged 3-12 after they have their tonsils removed.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 3 Years to 12 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT03995628 on ClinicalTrials.gov |
What this trial studies
This research aims to determine if a single oral dose of steroid can reduce pain and the need for narcotic medications in children after tonsillectomy. The study will be conducted in a randomized, double-blinded, placebo-controlled manner, where eligible patients will receive either dexamethasone or a placebo on the third day post-surgery. All participants will receive standard post-operative care, ensuring consistency across treatment. The study focuses on children aged 3-12 undergoing outpatient tonsillectomy with or without adenoidectomy.
Who should consider this trial
Good fit: Ideal candidates are children aged 3-12 who are undergoing outpatient tonsillectomy.
Not a fit: Patients with bleeding disorders or those who have used steroids or opioids prior to surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce post-operative pain and reliance on narcotics in children after tonsillectomy.
How similar studies have performed: Previous studies have shown that steroids can effectively reduce pain and opioid use in post-operative settings, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 3-12 * Tonsillectomy with or without adenoidectomy for any indication * Outpatient (same day) surgery Exclusion Criteria: * Bleeding disorder * Intra-operative surgical or anesthetic complication or unplanned admission * Pre-operative steroid use (defined as any steroid use greater than three days duration within 30 days prior to tonsillectomy) * Pre-operative opioid use (defined as any opioid use within 30 days prior to tonsillectomy) * Inability of parent/guardian to be contacted by phone for follow up * Inability or unwillingness of subject or legal guardian/representative to give informed consent
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Phayvanh Pecha, MD — Medical University of South Carolina
- Study coordinator: Phayvanh Pecha, MD
- Email: pechap@musc.edu
- Phone: 6122678739
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.