Betamethasone (Betapred®) as premedication for reducing postoperative vomiting and pain after tonsillectomy – a randomized, double-blind, placebo-controlled trial

INTERVENTION: Trade Name: Betapred Product Name: Betapred Pharmaceutical Form: Tablet INN or Proposed INN: Betamethasone sodium phosphate Other descriptive name: BETAMETHASONE SODIUM PHOSPHATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5‐ Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use CONDITION: 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] PRIMARY OUTCOME: 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.; 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: ; • Intensity of nausea daily according to the numeric VAS scale measurements.; • Number of vomiting episodes in accordance to daily reports, registered in the CRF and reported in the medical chart after the phone calls.; 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.; 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: Secondary end point(s): 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. This will be assessed be the following variables:; • Postoperative bleeding which need hospital care, collected by retrospective analyses of patient records. ; • Intensity of pain daily according to the numeric VAS scale measurements.; • Amount of pain relief medicine each day postoperatively, collected by analyzing the CRF lists and the information from the telephone interviews recorded in the patient´s chart. ; Timepoint(s) of evaluation of this end point: Postoperative bleeding which need hospital care, collected by retrospective analyses of patient records ‐ 30 days after surgery.; Intensity of pain daily according to the numeric VAS scale measurements ‐ for five days post‐op. ; Amount of pain relief medicine each day postoperatively, collected by analyzing the CRF lists and the information from the telephone interviews recorded in the patient´s chart ‐for five days post‐op. 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