Betapred as a prophylaxis to reduce vomiting and pain after removal of tonsils

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001261-16-SE

Enrollment

100

Registered

2018-04-18

Start date

2018-10-02

Completion date

Unknown

Last updated

2018-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain, nausea and vomiting following tonsillectomy in patients with chronic or recurrent tonsillitis.

Interventions

Trade Name: Betapred Product Name: Betapred Pharmaceutical Form: Tablet INN or Proposed INN: Betamethasone sodium phosphate Other descriptive name: BETAMETHASONE SODIUM PHOSPHATE Concentration unit: m

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. ;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. ;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. ;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	—

Measure

Time frame

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. ;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. ;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. ;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

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Sweden

Contacts

Public ContactKarin Ekström

Gothia Forum

karin.c.ekstrom@vgregion.se46700823426

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026