Effect of Steroids on Post-tonsillectomy Morbidities

NCT02401529 | Completed Phase 2 Results

• 1 other identifier: Bahammam-1
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Postoperative Pain; Postoperative Nausea and Vomiting

Keywords

Dexamethasone; Prednisolone; Tonsillectomy Nausea; Pain, Postoperative; Postoperative Nausea and Vomiting; Randomized controlled trial; Post-tonsillectomy pain; delayed feeding

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• Occurence of Post-operative Nausea

  Postoperative nausea occurence (yes, no)

  7 days

• 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

• Duration of Post-operative Nausea

  Postoperative nausea duration (no nausea,1 day, 2 days, 3 days, 4 days, if more specify)

  7 days

• Occurence of Postoperative Vomiting

  Postoperative vomiting occurrence (yes, no)

  7 days

• 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

Secondary Outcomes (3)

• Onset of 1st Post-operative Oral Intake

  Onset of 1st post-operative oral intake recorded within the 1st 3days post-surgery

• Average Amount of Meal Per Day

  3 days

• Average Frequency of Meals Per Day

  average number of meals consumed per day for the 1st three days post-surgery

Study Arms (2)

IV dexamethasone and oral Prednisolone

EXPERIMENTAL

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).

Drug: IV dexamethasone; Drug: Oral prednisolone; Drug: Paracetamol

Placebo

ACTIVE COMPARATOR

Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).

Drug: Paracetamol; Drug: IV saline

Interventions

IV dexamethasone DRUG

0.15 mg/kg

Also known as: Decadron

IV dexamethasone and oral Prednisolone

Oral prednisolone DRUG

0.25mg/kg/day for 7 days then tapering for next 7 days

Also known as: Predosone

IV dexamethasone and oral Prednisolone

Paracetamol DRUG

acetaminophen 15 mg/kg/dose every 6 hours

Also known as: Adol

IV dexamethasone and oral Prednisolone; Placebo

IV saline DRUG

IV saline

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 5 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Fahd General Hospital: lead

Related Publications (25)

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  PMID: 12670818 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.

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  PMID: 8502095 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.

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• 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.

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• 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.

  PMID: 21108754 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.

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• 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.

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• 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.

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• 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.

  PMID: 10625002 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.

  PMID: 19395984 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.

  PMID: 16960268 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.

  PMID: 7189499 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.

  PMID: 1586608 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.

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• 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.

  PMID: 9296405 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.

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• 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.

  PMID: 17544156 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.

  PMID: 22868016 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.

  PMID: 15979735 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.

  PMID: 12535500 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.

  PMID: 15892392 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Interventions

Dexamethasone; Calcium Dobesilate; Prednisolone; Acetaminophen; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

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; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr Faris Ahmed Bahammam
• Organization: King Fahd General Hospital

dr_farisbahammam@yahoo.com

00966554699544

Study Officials

• Dr.Faris A Bahammam, MD

  ORL and Head & Neck Surgeon

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 21, 2015
• First Posted: March 30, 2015
• Study Start: January 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: July 15, 2015
• Results First Posted: July 15, 2015

Record last verified: 2015-06