Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2013-01-31
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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IV dexamethasone and oral Prednisolone
Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
IV dexamethasone
0.15 mg/kg
Oral prednisolone
0.25mg/kg/day for 7 days then tapering for next 7 days
Paracetamol
acetaminophen 15 mg/kg/dose every 6 hours
Placebo
Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
Paracetamol
acetaminophen 15 mg/kg/dose every 6 hours
IV saline
IV saline
Interventions
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IV dexamethasone
0.15 mg/kg
Oral prednisolone
0.25mg/kg/day for 7 days then tapering for next 7 days
Paracetamol
acetaminophen 15 mg/kg/dose every 6 hours
IV saline
IV saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
5 Years
20 Years
ALL
Yes
Sponsors
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King Fahd General Hospital
OTHER_GOV
Responsible Party
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Dr Faris Bahammam
Dr
Principal Investigators
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Dr.Faris A Bahammam, MD
Role: PRINCIPAL_INVESTIGATOR
ORL and Head & Neck Surgeon
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Bahammam-1
Identifier Type: -
Identifier Source: org_study_id
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