Effect of Steroids on Post-tonsillectomy Morbidities

Postoperative Pain Clinical Trial

Official title:

Effect of Steroids on Post-tonsillectomy Morbidities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02401529
• Other study ID #: Bahammam-1
• Status: Completed
• Phase: Phase 2
• First received: March 21, 2015
• Last updated: June 20, 2015
• Start date: January 2013
• Est. completion date: March 2014

Study information

• Verified date: June 2015
• Source: King Fahd General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

The effect of preoperative systemic steroids on post-tonsillectomy morbidities such as pain, nausea, vomiting and delayed feeding was proven. However, 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 the aforementioned morbidities and on decreasing the duration and costs of hospital stays. patients who were in the waiting list for tonsillectomy procedure were screened for medical history and those who comply with the inclusion criteria were randomly assigned into two equal groups of 50 patients each. One group was selected to receive a single postoperative dose of intravenous dexamethasone followed by oral steroids; the second group received placebo. Questionnaires investigating postoperative pain, nausea, vomiting, and oral intake were answered by patients, parents or guardians where applicable.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 20 Years

Eligibility

Inclusion Criteria:

• Patients in the waiting list for tonsillectomy under general anesthesia who accepted to participate in the study.

Exclusion Criteria:

• Patients who are allergic to steroids or those who have medical conditions which contraindicate the use of steroid i.e diabetes mellitus, gastritis, or hypertension and those who were on exogenous steroid supplements.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Postoperative Pain

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Fahd General Hospital

References & Publications (25)

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. — View Citation

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. — View Citation

Andersen R, Krohg K. Pain as a major cause of postoperative nausea. Can Anaesth Soc J. 1976 Jul;23(4):366-9. — View Citation

Baxendale BR, Vater M, Lavery KM. Dexamethasone reduces pain and swelling following extraction of third molar teeth. Anaesthesia. 1993 Nov;48(11):961-4. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. English, French. — View Citation

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. Epub 2007 Jun 1. — View Citation

Fredrikson M, Hursti T, Fürst CJ, Steineck G, Börjeson 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. — View Citation

Harris AL. Cytotoxic-therapy-induced vomiting is mediated via enkephalin pathways. Lancet. 1982 Mar 27;1(8274):714-6. — View Citation

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. doi: 08.2012/JCPSP.505509. — View Citation

Henzi I, Walder B, Tramèr MR. Dexamethasone for the prevention of postoperative nausea and vomiting: a quantitative systematic review. Anesth Analg. 2000 Jan;90(1):186-94. — View Citation

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. — View Citation

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. Review. — View Citation

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. Epub 2005 Jun 24. — View Citation

Leach J, Manning S, Schaefer S. Comparison of two methods of tonsillectomy. Laryngoscope. 1993 Jun;103(6):619-22. Review. — View Citation

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. — View Citation

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. — View Citation

Rich WM, Abdulhayoglu G, DiSaia PJ. Methylprednisolone as an antiemetic during cancer chemotherapy--a pilot study. Gynecol Oncol. 1980 Apr;9(2):193-8. — View Citation

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. — View Citation

Splinter W, Roberts DJ. Prophylaxis for vomiting by children after tonsillectomy: dexamethasone versus perphenazine. Anesth Analg. 1997 Sep;85(3):534-7. — View Citation

Steward DL, Welge JA, Myer CM. Steroids for improving recovery following tonsillectomy in children. Cochrane Database Syst Rev. 2003;(1):CD003997. Review. Update in: Cochrane Database Syst Rev. 2011;(8):CD003997. — View Citation

Thomas S, Beevi S. Epidural dexamethasone reduces postoperative pain and analgesic requirements. Can J Anaesth. 2006 Sep;53(9):899-905. — View Citation

Weimert TA, Babyak JW, Richter HJ. Electrodissection tonsillectomy. Arch Otolaryngol Head Neck Surg. 1990 Feb;116(2):186-8. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Severity of Post-operative Pain	5 grades (pain free, low disability and low intensity, low disability and high intensity, high disability and moderate intensity, high disability and severly limiting)	The severest pain grade felt within a week	No
Primary	Duration of Post-operative Pain	4 selections (1 day, 2 days, 3 days, if more specify)	number of days at which pain was experienced within the the 1st sevn days post -surgery	No
Primary	Occurence of Post-operative Nausea	Postoperative nausea occurence (yes, no)	7 days	No
Primary	Onset of Post-operative Nausea	Postoperative nausea onset (no nausea, immediate, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day, 7th day)	onset of 1st ocurence of nausea attack within the 1st week post-surgery	No
Primary	Duration of Post-operative Nausea	Postoperative nausea duration (no nausea,1 day, 2 days, 3 days, 4 days, if more specify)	7 days	No
Primary	Occurence of Postoperative Vomiting	Postoperative vomiting occurrence (yes, no)	7 days	No
Primary	Total Number of Post-operative Vomiting Episodes	Postoperative vomiting number of attacks (no vomiting,1, 2, 3, if more specify)	total number of post-operative vomiting episodes which were experienced within the 1st week post-surgery	No
Secondary	Onset of 1st Post-operative Oral Intake	feeding onset (1st day i. surgery day, 2nd day, 3rd day)	Onset of 1st post-operative oral intake recorded within the 1st 3days post-surgery	No
Secondary	Average Amount of Meal Per Day	adequacy of meals (inadequate, adequate)	3 days	No
Secondary	Average Frequency of Meals Per Day	average frequency of meals (1 meal, 2 meals, if more specify)	average number of meals consumed per day for the 1st three days post-surgery	No