Betamethasone (Betapred®) as Premedication for Reducing Postoperative Vomiting and Pain After Tonsillectomy
1 other identifier
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2019
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2018
CompletedFirst Posted
Study publicly available on registry
December 20, 2018
CompletedStudy Start
First participant enrolled
September 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2025
CompletedMay 14, 2024
May 1, 2024
5.8 years
November 15, 2018
May 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Postoperative pain
0-5 days postop
Other Outcomes (1)
Postoperative bleeding
0-30 days postop
Study Arms (2)
Betapred
ACTIVE COMPARATOR16 'Betamethason Sodium Phosphate' tablets dissolved in one ml of water as part of the premedications given to the patient 30 min before the surgery
Placebo
PLACEBO COMPARATOROne ml of 10% glucose solution as part of the premedications given to the patient 30 min before the surgery
Interventions
Glucose solution that can be used for injection, but in this case it is used perorally (one ml)
Eligibility Criteria
You may qualify if:
- Signed informed consent Age over 12 years Planned for elective bilateral tonsillectomy
You may not qualify if:
- Insulin dependent diabetes mellitus
- NSAID or corticosteroid intolerance
- Pregnancy
- Gastric ulcer
- Immunodeficiency
- Treatment for chronic pain
- Psychiatric disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Umeå Universitylead
Study Sites (1)
Sunderby sjukhus
Luleå, 971 80, Sweden
Related Publications (9)
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.
PMID: 21804499BACKGROUNDMcKean 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.
PMID: 16441800BACKGROUNDStewart 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.
PMID: 12383289BACKGROUNDCarr 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.
PMID: 10604415BACKGROUNDCzarnetzki 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.
PMID: 19066382BACKGROUNDPlante 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.
PMID: 22930703BACKGROUNDJohansson 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.
BACKGROUNDBellis 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.
PMID: 24942713BACKGROUNDChu 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.
PMID: 24184695BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Krister Tano, MD, PhD
Umeå University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Administrator gives the study number and check the randomization list and thereafter gives the drug/placebo to a Health care personnel, who does not know if it is placebo or drug.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2018
First Posted
December 20, 2018
Study Start
September 10, 2019
Primary Completion
June 20, 2025
Study Completion
December 15, 2025
Last Updated
May 14, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share