Betapred as a prophylaxis to reduce vomiting and pain after removal of tonsils
Phase 1
- Conditions
- Postoperative pain, nausea and vomiting following tonsillectomy in patients with chronic or recurrent tonsillitis.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
- Registration Number
- EUCTR2018-001261-16-SE
- Lead Sponsor
- ÖNH-kliniken Sunderby Sjukhus
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
1.Signed informed consent
2.Age over 12 years
3.Planned for elective bilateral tonsillectomy
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1
Exclusion Criteria
1.Insulin dependent diabetes mellitus
2.NSAID or corticosteroid intolerance
3.Pregnancy
4.Gastric ulcer
5. Immunodeficiency
6. Treatment for chronic pain
7. Psychiatric disorders
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to verify if 8 mg of betamethasone at adolescents and adult TE operations can significantly reduce PONV.<br>;Secondary Objective: The secondary objective is to verify that 8 mg of betamethasone in adolescents and adult TE operations reduces postoperative pain but does not increase the postoperative bleeding risks.<br>;Primary end point(s): The primary objective of this study is to verify if 8 mg of betamethasone at adolescents and adult TE operations can significantly reduce PONV, and it will be assessed by: <br>•Intensity of nausea daily according to the numeric VAS scale measurements.<br>•Number of vomiting episodes in accordance to daily reports, registered in the CRF and reported in the medical chart after the phone calls.<br>;Timepoint(s) of evaluation of this end point: The patient register primary endpoints for five days postop. Day 1 and 5 postop a nurse make a phone call in order to collect the data from the patients´s scoring of these endpoints
- Secondary Outcome Measures
Name Time Method