Metamizole vs. ibuprofen at home after day case surgery : A double-blind randomised controlled noninferiority trial
BACKGROUND: NSAIDs and paracetamol are the cornerstones of pain treatment after day case surgery. However, NSAIDs have numerous contraindications and consequently are not suitable in up to 25% of patients. Metamizole is a non-opioid compound with a favourable gastro-intestinal and cardiovascular profile compared with NSAIDs.
OBJECTIVES: The study aimed to assess if a combination of metamizole and paracetamol is noninferior to a combination of ibuprofen and paracetamol in treating pain at home after painful day case surgery.
DESIGN: A double-blind randomised controlled trial.
SETTING: Single centre.
PATIENTS: Two hundred patients undergoing elective ambulatory haemorrhoid surgery, arthroscopic shoulder or knee surgery, or inguinal hernia repair.
INTERVENTION: Patients were randomly allocated to receive either metamizole and paracetamol (n = 100) or ibuprofen and paracetamol (n = 100) orally for four days.
MAIN OUTCOME MEASURES: Average postoperative pain intensity using a numerical rating scale and use of rescue medication were measured in the postanaesthesia care unit (PACU) and on postoperative days (POD) 1 to 3. A difference in mean numerical rating scale score of 1 point or less was considered noninferior. Adverse effects of study medication and satisfaction with study medication were measured on PODs 1 to 3 by telephone follow-up.
RESULTS: In the PACU, the difference in mean ± SD pain score between metamizole and paracetamol and ibuprofen and paracetamol was 0.85 ± 0.78. From POD 1 to 3, this difference was lower than 1, resulting in noninferiority. Rescue opioid consumption in the PACU and on PODs 1 and 3 was not significantly different between treatment groups. Rescue opioid consumption on POD2 was significantly higher in the ibuprofen and paracetamol group (P = 0.042). Adverse effects of study medication and overall patient satisfaction were similar in both groups.
CONCLUSION: Paracetamol/metamizole and paracetamol/ibuprofen are equally effective in treatment of acute postoperative pain at home after ambulatory surgery with comparable patient satisfaction levels.
TRIAL REGISTRATION: European Union Clinical Trials Register 2015-003987-35.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2019 |
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| Erschienen: |
2019 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:36 |
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| Enthalten in: |
European journal of anaesthesiology - 36(2019), 5 vom: 04. Mai, Seite 351-359 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Stessel, Björn [VerfasserIn] |
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| Links: |
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| Themen: |
362O9ITL9D |
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| Anmerkungen: |
Date Completed 02.12.2019 Date Revised 02.12.2019 published: Print Citation Status MEDLINE |
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| doi: |
10.1097/EJA.0000000000000972 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM295684283 |
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| 100 | 1 | |a Stessel, Björn |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Metamizole vs. ibuprofen at home after day case surgery |b A double-blind randomised controlled noninferiority trial |
| 264 | 1 | |c 2019 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 02.12.2019 | ||
| 500 | |a Date Revised 02.12.2019 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: NSAIDs and paracetamol are the cornerstones of pain treatment after day case surgery. However, NSAIDs have numerous contraindications and consequently are not suitable in up to 25% of patients. Metamizole is a non-opioid compound with a favourable gastro-intestinal and cardiovascular profile compared with NSAIDs | ||
| 520 | |a OBJECTIVES: The study aimed to assess if a combination of metamizole and paracetamol is noninferior to a combination of ibuprofen and paracetamol in treating pain at home after painful day case surgery | ||
| 520 | |a DESIGN: A double-blind randomised controlled trial | ||
| 520 | |a SETTING: Single centre | ||
| 520 | |a PATIENTS: Two hundred patients undergoing elective ambulatory haemorrhoid surgery, arthroscopic shoulder or knee surgery, or inguinal hernia repair | ||
| 520 | |a INTERVENTION: Patients were randomly allocated to receive either metamizole and paracetamol (n = 100) or ibuprofen and paracetamol (n = 100) orally for four days | ||
| 520 | |a MAIN OUTCOME MEASURES: Average postoperative pain intensity using a numerical rating scale and use of rescue medication were measured in the postanaesthesia care unit (PACU) and on postoperative days (POD) 1 to 3. A difference in mean numerical rating scale score of 1 point or less was considered noninferior. Adverse effects of study medication and satisfaction with study medication were measured on PODs 1 to 3 by telephone follow-up | ||
| 520 | |a RESULTS: In the PACU, the difference in mean ± SD pain score between metamizole and paracetamol and ibuprofen and paracetamol was 0.85 ± 0.78. From POD 1 to 3, this difference was lower than 1, resulting in noninferiority. Rescue opioid consumption in the PACU and on PODs 1 and 3 was not significantly different between treatment groups. Rescue opioid consumption on POD2 was significantly higher in the ibuprofen and paracetamol group (P = 0.042). Adverse effects of study medication and overall patient satisfaction were similar in both groups | ||
| 520 | |a CONCLUSION: Paracetamol/metamizole and paracetamol/ibuprofen are equally effective in treatment of acute postoperative pain at home after ambulatory surgery with comparable patient satisfaction levels | ||
| 520 | |a TRIAL REGISTRATION: European Union Clinical Trials Register 2015-003987-35 | ||
| 650 | 4 | |a Equivalence Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 7 | |a Analgesics, Non-Narcotic |2 NLM | |
| 650 | 7 | |a Acetaminophen |2 NLM | |
| 650 | 7 | |a 362O9ITL9D |2 NLM | |
| 650 | 7 | |a Dipyrone |2 NLM | |
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| 650 | 7 | |a Ibuprofen |2 NLM | |
| 650 | 7 | |a WK2XYI10QM |2 NLM | |
| 700 | 1 | |a Boon, Michiel |e verfasserin |4 aut | |
| 700 | 1 | |a Pelckmans, Caroline |e verfasserin |4 aut | |
| 700 | 1 | |a Joosten, Elbert A |e verfasserin |4 aut | |
| 700 | 1 | |a Ory, Jean-Paul |e verfasserin |4 aut | |
| 700 | 1 | |a Wyckmans, Werner |e verfasserin |4 aut | |
| 700 | 1 | |a Evers, Stefan |e verfasserin |4 aut | |
| 700 | 1 | |a van Kuijk, Sander M J |e verfasserin |4 aut | |
| 700 | 1 | |a Van de Velde, Marc |e verfasserin |4 aut | |
| 700 | 1 | |a Buhre, Wolfgang F F A |e verfasserin |4 aut | |
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