Metamizole versus ibuprofen at home after day surgery: study protocol for a randomised controlled trial
| Autor: | Wolfgang Buhre, Michiel Boon, Luc Jamaer, Björn Stessel, Jasperina Dubois, Stefan Evers, Sander M. J. van Kuijk, Daisy M. N. Hoofwijk, Elbert A.J. Joosten, Jean-Paul Ory |
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| Přispěvatelé: | STESSEL, Bjorn, Boon, Michiel, Joosten, Elbert A., Ory, Jean-Paul, EVERS, Stefan, van Kuijk, Sander M. J., Dubois, Jasperina, Hoofwijk, Daisy, Jamaer, Luc, Buhre, Wolfgang F. F. A., Anesthesiologie, RS: MHeNs - R3 - Neuroscience, MUMC+: MA Anesthesiologie (9), MUMC+: KIO Kemta (9), Epidemiologie, MUMC+: MA AIOS Anesthesiologie (9) |
| Jazyk: | angličtina |
| Předmět: |
medicine.medical_specialty
Analgesic Dipyrone Medicine (miscellaneous) ambulatory surgery day surgery metamizole dipyrone NSAID recovery Functional Recovery Index EQ-5D acute pain postoperative pain law.invention Postoperative pain Study Protocol 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Recovery 030202 anesthesiology law medicine media_common.cataloged_instance Pharmacology (medical) European union Adverse effect media_common Metamizole business.industry Ambulatory surgery Ibuprofen medicine.disease Surgery Clinical trial Inguinal hernia Anesthesia Physical therapy Day surgery business Acute pain 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Trials, 17:471. BioMed Central Ltd Trials |
| ISSN: | 1745-6215 |
| DOI: | 10.1186/s13063-016-1586-8 |
| Popis: | Background Postoperative pain and, in a more extended perspective, quality of recovery (QOR) should be considered the principal endpoints after day surgery. Non-steroidal anti-inflammatory drugs (NSAIDs) and paracetamol are a cornerstone of pain treatment after painful day surgery. Nevertheless, NSAIDs are not always sufficiently effective, have numerous contraindications, and consequently are not suitable in up to 25 % of all patients. Metamizole is a non-opioid compound with a favourable gastrointestinal, cardiovascular and cerebrovascular profile compared to NSAIDs. The aim of this study is to assess if a combination of metamizole and paracetamol is non-inferior to a combination of ibuprofen and paracetamol in the treatment of acute postoperative pain at home after painful day case surgery. In addition, we aim to assess and compare quality of recovery (QOR) profiles of both groups. Methods/Design This is an investigator-initiated, double-blind, randomised controlled, non-inferiority trial. A total of 200 patients undergoing elective haemorrhoid surgery, arthroscopic shoulder or knee surgery, or inguinal hernia repair in a day care setting will be randomised to receive either a combination of metamizole and paracetamol (MP) or a combination of ibuprofen and paracetamol (IP). Participants will take study medication orally for 4 days. Primary endpoints are average postoperative pain intensity measured by an 11-point Numeric Rating Scale at postoperative day 1 and QOR profile measured by the Functional Recovery Index (FRI), the 1-item Global Surgical Recovery (GSR) index and the EuroQol (EQ-5D) questionnaire at days 1, 2, 3, 4, 7, 14 and 28 postoperatively. Secondary outcomes include compliance with study medication, adverse effects of study medication, use of rescue medication and satisfaction with study medication, surgery and hospital care and telephone follow-up. Discussion This study will provide clinical evidence on the analgesic efficacy and safety of a combination of metamizole and paracetamol in treating postoperative pain at home after painful day surgery. This study may also provide an insight into QOR profile after four different types of surgery and into the interrelationship between three different instruments used to assess QOR. Trial status Recruitment is currently ongoing. Trial registration European Union Clinical Trials Register 2015-003987-35. Registered 10 November 2015. |
| Databáze: | OpenAIRE |
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