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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Placebo | Active Comparator | Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV dexamethasone | Drug | 0.15 mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Average Amount of Meal Per Day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr.Faris A Bahammam, MD | ORL and Head & Neck Surgeon | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12670818 | 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. | |
| 2297411 | 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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116 participants were initially considered for the study. However, only 100 were considered in the final results. some were excluded due to not matching inclusion criteria. others failed to attend follow up visits, adhere to treatment protocol or complete the questionnaire as required.
Please refer to section ( period 1) for further details.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Number | participants | The severest pain grade felt within a week |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Faris Ahmed Bahammam | King Fahd General Hospital | 00966554699544 | dr_farisbahammam@yahoo.com |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| D011239 | Prednisolone |
| D000082 | Acetaminophen |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Oral prednisolone | Drug | 0.25mg/kg/day for 7 days then tapering for next 7 days |
|
|
| Paracetamol | Drug | acetaminophen 15 mg/kg/dose every 6 hours |
|
|
| IV saline | Drug | IV saline |
|
|
adequacy of meals (inadequate, adequate)
| 3 days |
| 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 |
| 8502095 | 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. |
| 17914084 | 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. |
| 8250191 | 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. |
| 21108754 | 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. |
| 22879656 | 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. |
| 25291409 | 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. |
| 7347 | 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. |
| 16441800 | 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. |
| 3457335 | 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. |
| 1853495 | 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. |
| 10625002 | 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. |
| 19395984 | 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. |
| 16960268 | 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. |
| 7189499 | 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. |
| 1586608 | 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. |
| 6122010 | 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. |
| 9296405 | 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. |
| 23956857 | 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. |
| 17544156 | 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. |
| 22868016 | 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. |
| 15979735 | 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. |
| 12535500 | 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. |
| 15892392 | 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. |
| Protocol Violation |
|
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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 |
|
|
|
| Primary | Duration of Post-operative Pain | 4 selections (1 day, 2 days, 3 days, if more specify) | Posted | Number | participants | number of days at which pain was experienced within the the 1st sevn days post -surgery |
|
|
|
|
| Primary | Occurence of Post-operative Nausea | Postoperative nausea occurence (yes, no) | Posted | Number | participants | 7 days |
|
|
|
|
| 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) | Posted | Number | participants | onset of 1st ocurence of nausea attack within the 1st week post-surgery |
|
|
|
|
| Primary | Duration of Post-operative Nausea | Postoperative nausea duration (no nausea,1 day, 2 days, 3 days, 4 days, if more specify) | Posted | Number | participants | 7 days |
|
|
|
|
| Primary | Occurence of Postoperative Vomiting | Postoperative vomiting occurrence (yes, no) | Posted | Number | participants | 7 days |
|
|
|
|
| Primary | Total Number of Post-operative Vomiting Episodes | Postoperative vomiting number of attacks (no vomiting,1, 2, 3, if more specify) | Posted | Number | participants | total number of post-operative vomiting episodes which were experienced within the 1st week post-surgery |
|
|
|
|
| Secondary | Onset of 1st Post-operative Oral Intake | feeding onset (1st day i. surgery day, 2nd day, 3rd day) | Posted | Number | participants | Onset of 1st post-operative oral intake recorded within the 1st 3days post-surgery |
|
|
|
|
| Secondary | Average Amount of Meal Per Day | adequacy of meals (inadequate, adequate) | Posted | Number | participants | 3 days |
|
|
|
|
| Secondary | Average Frequency of Meals Per Day | average frequency of meals (1 meal, 2 meals, if more specify) | Posted | Number | participants | average number of meals consumed per day for the 1st three days post-surgery |
|
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | 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 | 0 | 50 | 0 | 50 |
| Excess stomach acid | Gastrointestinal disorders | Systematic Assessment |
|
| Bleeding | Surgical and medical procedures | Systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| three days |
|
| 1st day |
|
| immediately and 1st day |
|
| two days |
|
| three days |
|
| twice |
|
| three times |
|
| more than 3 times |
|
| 3 meals |
|