Steroids and Pain Control After Tonsillectomy

NCT03995628 | Completed Phase 2 FDA Drug

• 1 other identifier: 00081346
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

Brief Summary

This research study aims to find out if a single oral dose of steroid after tonsillectomy will reduce pain and decrease the need for narcotic medications.

Conditions

Tonsillitis; Obstructive Sleep Apnea of Child

Outcome Measures

Primary Outcomes (1)

• Mean Visual Analog Score of Pain

  On postoperative days 0-6, the caregiver assesses participant pain using The Faces Pain Scale-Revised, which measures pain via a visual analog score. The visual analog score is an integer value between 0-10, where 0 represents no pain and 10 represents maximum pain. The mean visual analog score on postoperative day 1-3 and the mean visual analog score on postoperative day 4-6 will be calculated for comparison between arms of the study. Lower mean visual analog scores on days 4-6 represent a better outcome.

  Postoperative day 6

Secondary Outcomes (7)

• Mean Opioid Consumption

  Postoperative day 6

• Mean NSAID and Acetaminophen Consumption

  Postoperative day 6

• Rate of Nausea and Vomiting

  Postoperative day 6

• Diet and Activity Levels

  Postoperative day 6

• Rate of 30-Day Readmission

  Postoperative day 30

Study Arms (2)

Steroid Group

EXPERIMENTAL

Participants will receive a one-time dose of oral dexamethasone at 0.5 mg/kg on the third post-operative day

Drug: Dexamethasone

No Steroid Group

PLACEBO COMPARATOR

Participants will receive placebo on third post-operative day

Drug: Placebo

Interventions

Dexamethasone DRUG

One dose of dexamethasone (0.5 mg/kg) on post-operative day 3 after tonsillectomy

Also known as: Decadron

Steroid Group

Placebo DRUG

One dose of placebo on post-operative day 3 after tonsillectomy

No Steroid Group

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 3-12
• Tonsillectomy with or without adenoidectomy for any indication
• Outpatient (same day) surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (7)

• Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Goodenough B. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001 Aug;93(2):173-183. doi: 10.1016/S0304-3959(01)00314-1.

  PMID: 11427329 BACKGROUND

• Tan GX, Tunkel DE. Control of Pain After Tonsillectomy in Children: A Review. JAMA Otolaryngol Head Neck Surg. 2017 Sep 1;143(9):937-942. doi: 10.1001/jamaoto.2017.0845.

  PMID: 28662233 BACKGROUND

• Batistaki C, Kaminiotis E, Papadimos T, Kostopanagiotou G. A Narrative Review of the Evidence on the Efficacy of Dexamethasone on Postoperative Analgesic Consumption. Clin J Pain. 2017 Nov;33(11):1037-1046. doi: 10.1097/AJP.0000000000000486.

  PMID: 28177939 BACKGROUND

• Vlok R, Melhuish TM, Chong C, Ryan T, White LD. Adjuncts to local anaesthetics in tonsillectomy: a systematic review and meta-analysis. J Anesth. 2017 Aug;31(4):608-616. doi: 10.1007/s00540-017-2310-x. Epub 2017 Jan 24.

  PMID: 28120104 BACKGROUND

• Redmann AJ, Maksimoski M, Brumbaugh C, Ishman SL. The effect of postoperative steroids on post-tonsillectomy pain and need for postoperative physician contact. Laryngoscope. 2018 Sep;128(9):2187-2192. doi: 10.1002/lary.27167. Epub 2018 Mar 24.

  PMID: 29573428 BACKGROUND

• Rosen HI, Bergh IH, Oden A, Martensson LB. Patients experiences of pain following day surgery - at 48 hours, seven days and three months. Open Nurs J. 2011;5:52-9. doi: 10.2174/1874434601105010052. Epub 2011 Jul 6.

  PMID: 21769308 BACKGROUND

• Cronin J, Kennedy U, McCoy S, An Fhaili SN, Crispino-O'Connell G, Hayden J, Wakai A, Walsh S, O'Sullivan R. Single dose oral dexamethasone versus multi-dose prednisolone in the treatment of acute exacerbations of asthma in children who attend the emergency department: study protocol for a randomized controlled trial. Trials. 2012 Aug 21;13:141. doi: 10.1186/1745-6215-13-141.

  PMID: 22909281 BACKGROUND

MeSH Terms

Conditions

Tonsillitis

Interventions

Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Phayvanh Pecha, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 24, 2019
• Study Start: December 18, 2018
• Primary Completion: September 15, 2025
• Study Completion: December 31, 2025
• Last Updated: January 12, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)