Effect of Steroids on Post-tonsillectomy Morbidities

Summary

This study aims to evaluate the effect of postoperative systemic rapid onset and short acting dexamethasone followed by a tapering dose of oral prednisolone on post-tonsillectomy morbidities. Half of the patients who comply with the inclusion criteria were selected to receive a single postoperative dose of intravenous dexamethasone followed by oral steroids; the second group received placebo.

Timeline

Start

2013-01

Primary completion

2014-03

Completion

2014-03

Outcome

Met primary endpoint

registry analysis (superiority or other test); IV Dexamethasone and Oral Prednisolone vs Placebo; p = 0.033; Chi-squared NCT02401529 ↗

registry analysis (superiority or other test); IV Dexamethasone and Oral Prednisolone vs Placebo; p = 0.026; Chi-squared NCT02401529 ↗

registry analysis (superiority or other test); IV Dexamethasone and Oral Prednisolone vs Placebo; p = 0.016; Chi-squared NCT02401529 ↗

registry analysis (superiority or other test); IV Dexamethasone and Oral Prednisolone vs Placebo; p = 0.019; Chi-squared NCT02401529 ↗

registry analysis (superiority or other test); IV Dexamethasone and Oral Prednisolone vs Placebo; p = 0.012; Chi-squared NCT02401529 ↗

registry analysis (superiority or other test); IV Dexamethasone and Oral Prednisolone vs Placebo; p = 0.024; Chi-squared NCT02401529 ↗

registry analysis (superiority or other test); IV Dexamethasone and Oral Prednisolone vs Placebo; p = 0.02; Chi-squared NCT02401529 ↗

Publications

• Background Elhakim M, Ali NM, Rashed I, Riad MK, Refat M. Dexamethasone reduces postoperative vomiting and pain after pediatric tonsillectomy. Can J Anaesth. 2003 Apr;50(4):392-7. doi: 10.1007/BF03021038. English, French.
• Background Weimert TA, Babyak JW, Richter HJ. Electrodissection tonsillectomy. Arch Otolaryngol Head Neck Surg. 1990 Feb;116(2):186-8. doi: 10.1001/archotol.1990.01870020062016.
• Background Leach J, Manning S, Schaefer S. Comparison of two methods of tonsillectomy. Laryngoscope. 1993 Jun;103(6):619-22. doi: 10.1288/00005537-199306000-00008.
• Background Jordan K, Sippel C, Schmoll HJ. Guidelines for antiemetic treatment of chemotherapy-induced nausea and vomiting: past, present, and future recommendations. Oncologist. 2007 Sep;12(9):1143-50. doi: 10.1634/theoncologist.12-9-1143.
• Background Baxendale BR, Vater M, Lavery KM. Dexamethasone reduces pain and swelling following extraction of third molar teeth. Anaesthesia. 1993 Nov;48(11):961-4. doi: 10.1111/j.1365-2044.1993.tb07474.x.
• Background Browning GG. Prophylactic steroids and/or antibiotics to reduce post-tonsillectomy morbidity: a yet unanswered conundrum. Clin Otolaryngol. 2010 Oct;35(5):417. doi: 10.1111/j.1749-4486.2010.02211.x. No abstract available.
• Background Hermans V, De Pooter F, De Groote F, De Hert S, Van der Linden P. Effect of dexamethasone on nausea, vomiting, and pain in paediatric tonsillectomy. Br J Anaesth. 2012 Sep;109(3):427-31. doi: 10.1093/bja/aes249.
• Background Park SK, Kim J, Kim JM, Yeon JY, Shim WS, Lee DW. Effects of oral prednisolone on recovery after tonsillectomy. Laryngoscope. 2015 Jan;125(1):111-7. doi: 10.1002/lary.24958. Epub 2014 Oct 7.
• Background Andersen R, Krohg K. Pain as a major cause of postoperative nausea. Can Anaesth Soc J. 1976 Jul;23(4):366-9. doi: 10.1007/BF03005916.
• Background McKean S, Kochilas X, Kelleher R, Dockery M. Use of intravenous steroids at induction of anaesthesia for adult tonsillectomy to reduce post-operative nausea and vomiting and pain: a double-blind randomized controlled trial. Clin Otolaryngol. 2006 Feb;31(1):36-40. doi: 10.1111/j.1749-4486.2006.01141.x.
• Background Beirne OR, Hollander B. The effect of methylprednisolone on pain, trismus, and swelling after removal of third molars. Oral Surg Oral Med Oral Pathol. 1986 Feb;61(2):134-8. doi: 10.1016/0030-4220(86)90173-8.
• Background Campbell WI, Kendrick RW. Postoperative dental pain--a comparative study of anti-inflammatory and analgesic agents. Ulster Med J. 1991 Apr;60(1):39-43.
• Background Henzi I, Walder B, Tramer MR. Dexamethasone for the prevention of postoperative nausea and vomiting: a quantitative systematic review. Anesth Analg. 2000 Jan;90(1):186-94. doi: 10.1097/00000539-200001000-00038.
• Background Alexander TH, Weisman MH, Derebery JM, Espeland MA, Gantz BJ, Gulya AJ, Hammerschlag PE, Hannley M, Hughes GB, Moscicki R, Nelson RA, Niparko JK, Rauch SD, Telian SA, Brookhouser PE, Harris JP. Safety of high-dose corticosteroids for the treatment of autoimmune inner ear disease. Otol Neurotol. 2009 Jun;30(4):443-8. doi: 10.1097/MAO.0b013e3181a52773.
• Background Thomas S, Beevi S. Epidural dexamethasone reduces postoperative pain and analgesic requirements. Can J Anaesth. 2006 Sep;53(9):899-905. doi: 10.1007/BF03022833.
• Background Rich WM, Abdulhayoglu G, DiSaia PJ. Methylprednisolone as an antiemetic during cancer chemotherapy--a pilot study. Gynecol Oncol. 1980 Apr;9(2):193-8. doi: 10.1016/0090-8258(80)90027-x. No abstract available.
• Background Fredrikson M, Hursti T, Furst CJ, Steineck G, Borjeson S, Wikblom M, Peterson C. Nausea in cancer chemotherapy is inversely related to urinary cortisol excretion. Br J Cancer. 1992 May;65(5):779-80. doi: 10.1038/bjc.1992.165. No abstract available.
• Background Harris AL. Cytotoxic-therapy-induced vomiting is mediated via enkephalin pathways. Lancet. 1982 Mar 27;1(8274):714-6. doi: 10.1016/s0140-6736(82)92625-3. No abstract available.
• Background Splinter W, Roberts DJ. Prophylaxis for vomiting by children after tonsillectomy: dexamethasone versus perphenazine. Anesth Analg. 1997 Sep;85(3):534-7. doi: 10.1097/00000539-199709000-00010.
• Background Ahmad S, De Oliveira GS Jr, Fitzgerald PC, McCarthy RJ. The effect of intravenous dexamethasone and lidocaine on propofol-induced vascular pain: a randomized double-blinded placebo-controlled trial. Pain Res Treat. 2013;2013:734531. doi: 10.1155/2013/734531. Epub 2013 Jul 15.
• Background Fazel MR, Yegane-Moghaddam A, Forghani Z, Aghadoost D, Mahdian M, Fakharian E. The effect of dexamethasone on postoperative vomiting and oral intake after adenotonsillectomy. Int J Pediatr Otorhinolaryngol. 2007 Aug;71(8):1235-8. doi: 10.1016/j.ijporl.2007.04.015. Epub 2007 Jun 1.
• Background Hashmi MA, Ahmed A, Aslam S, Mubeen M. Post-tonsillectomy pain and vomiting:role of pre-operative steroids. J Coll Physicians Surg Pak. 2012 Aug;22(8):505-9.
• Background Kaan MN, Odabasi O, Gezer E, Daldal A. The effect of preoperative dexamethasone on early oral intake, vomiting and pain after tonsillectomy. Int J Pediatr Otorhinolaryngol. 2006 Jan;70(1):73-9. doi: 10.1016/j.ijporl.2005.05.013. Epub 2005 Jun 24.
• Background Steward DL, Welge JA, Myer CM. Steroids for improving recovery following tonsillectomy in children. Cochrane Database Syst Rev. 2003;(1):CD003997. doi: 10.1002/14651858.CD003997.
• Background Scarlett M, Tennant I, Ehikhametalor K, Nelson M. Vomiting post tonsillectomy at the University Hospital of the West Indies. West Indian Med J. 2005 Jan;54(1):59-64. doi: 10.1590/s0043-31442005000100012.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexamethasone	Small molecule	0.15 mg/kg	Intravenous
Subject	Prednisolone	Other / unclassified	0.25 mg/kg	Oral
Background	Acetaminophen	Small molecule	15 mg/kg	—

Indications

No indication recorded.