Clinical trial

Betamethasone (Betapred®) as Premedication for Reducing Postoperative Vomiting and Pain After Tonsillectomy - a Randomized, Double-blind, Placebo-controlled Trial

Name
Eudract: 2018-001261-16
Description
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 arms
Trial start
2019-09-10
Estimated PCD
2025-06-20
Trial end
2025-12-15
Status
Recruiting
Phase
Early phase I
Treatment
Betamethason Sodium Phosphate
Glucocorticoid
Arms:
Betapred
Other names:
Betapred
10% glucose solution
Glucose solution that can be used for injection, but in this case it is used perorally (one ml)
Arms:
Placebo
Size
100
Primary endpoint
Postoperative nausea and vomiting
0-5 days postop
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-blinded, placebo controlled and randomized study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-05-14

1 organization

2 products

4 indications

Organization
Umeå University
Indication
Tonsillectomy
Indication
Pain
Indication
Bleeding