Metamizole vs. ibuprofen at home after day case surgery A double-blind randomised controlled noninferiority trial

Bjoern Stessel; Michiel Boon; Caroline Pelckmans; Elbert A. Joosten; Jean-Paul Ory; Werner Wyckmans; Stefan Evers; Sander M. J. van Kuijk; Marc Van de Velde; Wolfgang F. F. A. Buhre

doi:10.1097/EJA.0000000000000972

Metamizole vs. ibuprofen at home after day case surgery A double-blind randomised controlled noninferiority trial

Bjoern Stessel^*, Michiel Boon, Caroline Pelckmans, Elbert A. Joosten, Jean-Paul Ory, Werner Wyckmans, Stefan Evers, Sander M. J. van Kuijk, Marc Van de Velde, Wolfgang F. F. A. Buhre

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

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.

Original language	English
Pages (from-to)	351-359
Number of pages	9
Journal	European Journal of Anaesthesiology
Volume	36
Issue number	5
DOIs	https://doi.org/10.1097/EJA.0000000000000972
Publication status	Published - May 2019

Keywords

POSTOPERATIVE PAIN RELIEF
NONSTEROIDAL ANTIINFLAMMATORY DRUGS
PATIENT-CONTROLLED ANALGESIA
INDUCED GASTRIC-ULCERS
NONOPIOID ANALGESICS
AMBULATORY SURGERY
DIPYRONE METAMIZOL
EFFICACY
PARACETAMOL
LORNOXICAM

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Stessel, B., Boon, M., Pelckmans, C., Joosten, E. A., Ory, J.-P., Wyckmans, W., Evers, S., van Kuijk, S. M. J., Van de Velde, M., & Buhre, W. F. F. A. (2019). Metamizole vs. ibuprofen at home after day case surgery A double-blind randomised controlled noninferiority trial. European Journal of Anaesthesiology, 36(5), 351-359. https://doi.org/10.1097/EJA.0000000000000972

@article{65d09a8032324652b4bcedb58bfe4d16,

title = "Metamizole vs. ibuprofen at home after day case surgery A double-blind randomised controlled noninferiority trial",

abstract = "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.",

keywords = "POSTOPERATIVE PAIN RELIEF, NONSTEROIDAL ANTIINFLAMMATORY DRUGS, PATIENT-CONTROLLED ANALGESIA, INDUCED GASTRIC-ULCERS, NONOPIOID ANALGESICS, AMBULATORY SURGERY, DIPYRONE METAMIZOL, EFFICACY, PARACETAMOL, LORNOXICAM",

author = "Bjoern Stessel and Michiel Boon and Caroline Pelckmans and Joosten, \{Elbert A.\} and Jean-Paul Ory and Werner Wyckmans and Stefan Evers and \{van Kuijk\}, \{Sander M. J.\} and \{Van de Velde\}, Marc and Buhre, \{Wolfgang F. F. A.\}",

note = "Funding Information: Assistance with the study: none. Financial support and sponsorship: the study was funded solely by departmental funding. Conflicts of interests: none. Presentation: data from this study were presented as a poster at the Euroanaesthesia 2018 conference of the European Society of Anaesthesiology in Copenhagen, Denmark in June 2018. Publisher Copyright: {\textcopyright} 2019 European Society of Anaesthesiology.",

year = "2019",

month = may,

doi = "10.1097/EJA.0000000000000972",

language = "English",

volume = "36",

pages = "351--359",

journal = "European Journal of Anaesthesiology",

issn = "0265-0215",

publisher = "Lippincott Williams \& Wilkins",

number = "5",

}

TY - JOUR

T1 - Metamizole vs. ibuprofen at home after day case surgery A double-blind randomised controlled noninferiority trial

AU - Stessel, Bjoern

AU - Boon, Michiel

AU - Pelckmans, Caroline

AU - Joosten, Elbert A.

AU - Ory, Jean-Paul

AU - Wyckmans, Werner

AU - Evers, Stefan

AU - van Kuijk, Sander M. J.

AU - Van de Velde, Marc

AU - Buhre, Wolfgang F. F. A.

N1 - Funding Information: Assistance with the study: none. Financial support and sponsorship: the study was funded solely by departmental funding. Conflicts of interests: none. Presentation: data from this study were presented as a poster at the Euroanaesthesia 2018 conference of the European Society of Anaesthesiology in Copenhagen, Denmark in June 2018. Publisher Copyright: © 2019 European Society of Anaesthesiology.

PY - 2019/5

Y1 - 2019/5

N2 - 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.

AB - 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.

KW - POSTOPERATIVE PAIN RELIEF

KW - NONSTEROIDAL ANTIINFLAMMATORY DRUGS

KW - PATIENT-CONTROLLED ANALGESIA

KW - INDUCED GASTRIC-ULCERS

KW - NONOPIOID ANALGESICS

KW - AMBULATORY SURGERY

KW - DIPYRONE METAMIZOL

KW - EFFICACY

KW - PARACETAMOL

KW - LORNOXICAM

U2 - 10.1097/EJA.0000000000000972

DO - 10.1097/EJA.0000000000000972

M3 - Article

C2 - 30946703

SN - 0265-0215

VL - 36

SP - 351

EP - 359

JO - European Journal of Anaesthesiology

JF - European Journal of Anaesthesiology

IS - 5

ER -

Metamizole vs. ibuprofen at home after day case surgery A double-blind randomised controlled noninferiority trial

Abstract

Keywords

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