E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postoperative pain, nausea and vomiting following tonsillectomy in patients with chronic or recurrent tonsillitis. |
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E.1.1.1 | Medical condition in easily understood language |
Postoperative pain, nausea and vomiting following tonsillectomy in patients with chronic or recurrent tonsillitis.
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to verify if 8 mg of betamethasone at adolescents and adult TE operations can significantly reduce PONV.
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Signed informed consent 2.Age over 12 years 3.Planned for elective bilateral tonsillectomy
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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.
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E.5.1.1 | 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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E.5.2 | 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.
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E.5.2.1 | 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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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |