Pain Clinical Trial
Official title:
Betamethasone (Betapred®) as Premedication for Reducing Postoperative Vomiting and Pain After Tonsillectomy - a Randomized, Double-blind, Placebo-controlled Trial
Betamethasone is currently given routinely in conjunction with tonsillectomy surgery at the majority of Ear, Nose & Throat clinics in Sweden. The scientific evidence regarding the effects of betamethasone in adults is limited when it comes to postoperative nausea (PONV), pain and postoperative bleeding.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 15, 2025 |
Est. primary completion date | June 20, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility | Inclusion Criteria: Signed informed consent Age over 12 years Planned for elective bilateral tonsillectomy Exclusion Criteria: - • Insulin dependent diabetes mellitus - NSAID or corticosteroid intolerance - Pregnancy - Gastric ulcer - Immunodeficiency - Treatment for chronic pain - Psychiatric disorders |
Country | Name | City | State |
---|---|---|---|
Sweden | Sunderby sjukhus | Luleå |
Lead Sponsor | Collaborator |
---|---|
Umeå University |
Sweden,
Bellis JR, Pirmohamed M, Nunn AJ, Loke YK, De S, Golder S, Kirkham JJ. Dexamethasone and haemorrhage risk in paediatric tonsillectomy: a systematic review and meta-analysis. Br J Anaesth. 2014 Jul;113(1):23-42. doi: 10.1093/bja/aeu152. — View Citation
Carr MM, Williams JG, Carmichael L, Nasser JG. Effect of steroids on posttonsillectomy pain in adults. Arch Otolaryngol Head Neck Surg. 1999 Dec;125(12):1361-4. doi: 10.1001/archotol.125.12.1361. — View Citation
Chu CC, Hsing CH, Shieh JP, Chien CC, Ho CM, Wang JJ. The cellular mechanisms of the antiemetic action of dexamethasone and related glucocorticoids against vomiting. Eur J Pharmacol. 2014 Jan 5;722:48-54. doi: 10.1016/j.ejphar.2013.10.008. Epub 2013 Nov 1. — View Citation
Czarnetzki C, Elia N, Lysakowski C, Dumont L, Landis BN, Giger R, Dulguerov P, Desmeules J, Tramer MR. Dexamethasone and risk of nausea and vomiting and postoperative bleeding after tonsillectomy in children: a randomized trial. JAMA. 2008 Dec 10;300(22):2621-30. doi: 10.1001/jama.2008.794. — View Citation
Islam MR, Haq MF, Islam MA, Meftahuzzaman SM, Sarkar SC, Rashid H, Rashid HU. Preoperative use of granisetron plus dexamethasone and granisetron alone in prevention of post operative nausea and vomiting in tonsillectomy. Mymensingh Med J. 2011 Jul;20(3):386-90. — View Citation
Johansson U, Sundgren C, Tano K, van den Berg J. The effect of Perioperative Bethamethasone on Post-operative Nausea, Vomiting and Pain in Children undergoing Tonsillar Surgery. British Journal of Anaesthetic&Recovery Nursing. 2011;11:24-29.
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. — View Citation
Plante J, Turgeon AF, Zarychanski R, Lauzier F, Vigneault L, Moore L, Boutin A, Fergusson DA. Effect of systemic steroids on post-tonsillectomy bleeding and reinterventions: systematic review and meta-analysis of randomised controlled trials. BMJ. 2012 Aug 28;345:e5389. doi: 10.1136/bmj.e5389. — View Citation
Stewart R, Bill R, Ullah R, McConaghy P, Hall SJ. Dexamethasone reduces pain after tonsillectomy in adults. Clin Otolaryngol Allied Sci. 2002 Oct;27(5):321-6. doi: 10.1046/j.1365-2273.2002.00588.x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Postoperative bleeding | Postoperative bleeding, visits to Health care. Medical records of the patients are used retrospectively in order to detect any postoperative bleeding that has caused a Contact with the Health care. Such events are divided in a) no of events not demanding new surgery and b) no of events demanding hemostasis by new surgery. | 0-30 days postop | |
Primary | Postoperative nausea and vomiting | Nausea/Vomiting postoperatively, numeric Visual Analogue Scale graded from 0 to 10, where 10 is the worst grade of nausea | 0-5 days postop | |
Secondary | Postoperative pain | Postoperative pain, numeric Visual Analogue Scale, graded from 0 to 10, where grade 10 is the worse pain | 0-5 days postop |
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