Study Summary
This trial will test if taking a steroid pill after tonsillectomy reduces pain and the need for narcotic drugs.
Eligible Conditions
- Tonsillitis
- Obstructive Sleep Apnea in Children
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: Postoperative day 30
Postoperative day 30
Rate of 30-Day Emergency Room Visits
Rate of 30-Day Readmission
Rate of Postoperative Oropharyngeal Hemorrhage
Postoperative day 6
Diet and Activity Levels
Mean NSAID and Acetaminophen Consumption
Mean Opioid Consumption
Mean Visual Analog Score of Pain
Rate of Nausea and Vomiting
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Ondansetron
2%Cerebrospinal fluid leak
2%Deep Vein Thrombosis
2%Fever
Trial Design
2 Treatment Groups
No Steroid Group
1 of 2
Steroid Group
1 of 2
Active Control
Experimental Treatment
150 Total Participants · 2 Treatment Groups
Primary Treatment: Dexamethasone · No Placebo Group · Phase 2
Steroid Group
Drug
Experimental Group · 1 Intervention: Dexamethasone · Intervention Types: DrugNo Steroid GroupNoIntervention Group · 1 Intervention: No Steroid Group · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: postoperative day 30
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
838 Previous Clinical Trials
5,378,418 Total Patients Enrolled
Clarice S Clemmens, MDPrincipal InvestigatorMedical University of South Carolina
Eligibility Criteria
Age 3 - 12 · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a diagnosis of Tonsillectomy with or without adenoidectomy for any indication.
References
- Rosén, Helena Inger, Ingrid Helena Bergh, Anders Odén, and Lena Birgitta Mårtensson. 2011. “Patients´ Experiences of Pain Following Day Surgery - at 48 Hours, Seven Days and Three Months”. The Open Nursing Journal. Bentham Science Publishers Ltd.. doi:10.2174/1874434601105010052.
- Cronin, John, Una Kennedy, Siobhan McCoy, Sinéad Nic an Fhailí, Gloria Crispino-O’Connell, John Hayden, Abel Wakai, Sean Walsh, and Ronan O’Sullivan. 2012. “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. Springer Science and Business Media LLC. doi:10.1186/1745-6215-13-141.
- Redmann, Andrew J., Matthew Maksimoski, Cheryl Brumbaugh, and Stacey L. Ishman. 2018. “The Effect of Postoperative Steroids on Post-tonsillectomy Pain and Need for Postoperative Physician Contact”. The Laryngoscope. Wiley. doi:10.1002/lary.27167.
- Hicks, Carrie L., Carl L. von Baeyer, Pamela A. Spafford, Inez van Korlaar, and Belinda Goodenough. 2001. “The Faces Pain Scale – Revised: Toward a Common Metric in Pediatric Pain Measurement”. Pain. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/s0304-3959(01)00314-1.
- Tan, Grace X., and David E. Tunkel. 2017. “Control of Pain After Tonsillectomy in Children”. JAMA Otolaryngology–head & Neck Surgery. American Medical Association (AMA). doi:10.1001/jamaoto.2017.0845.
- Batistaki, Chrysanthi, Evagelia Kaminiotis, Thomas Papadimos, and Georgia Kostopanagiotou. 2017. “A Narrative Review of the Evidence on the Efficacy of Dexamethasone on Postoperative Analgesic Consumption”. The Clinical Journal of Pain. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ajp.0000000000000486.
- Vlok, R., T. M. Melhuish, C. Chong, T. Ryan, and Leigh D. White. 2017. “Adjuncts to Local Anaesthetics in Tonsillectomy: A Systematic Review and Meta-analysis”. Journal of Anesthesia. Springer Science and Business Media LLC. doi:10.1007/s00540-017-2310-x.
- 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.
- 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.
- 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.
- 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.
- 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.
- Clarice Clemmens, MD 2018. "Steroids and Pain Control After Tonsillectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03995628.
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