Magnesium Sulfate Versus Lidocaine as an Adjunct for Renal Colic in the Emergency Department: A Randomized, Double-Blind Controlled Trial - 19/07/24

Doi : 10.1016/j.annemergmed.2024.06.015

Marwa Toumia, MD ^a,^b, Sarra Sassi, MD ^a,^c, Randa Dhaoui, MD ^a,^c, Cyrine Kouraichi, MD ^a,^c, Khaoula Bel Haj Ali, MD ^a,^c, Adel Sekma, MD ^a,^c, Asma Zorgati, MD ^d, Rahma Jaballah, MD ^d, Hajer Yaakoubi, MD ^d, Rym Youssef, MD ^d, Kaouthar Beltaief, MD ^a,^c, Zied Mezgar, MD ^e, Mariem Khrouf, MD ^e, Amira Sghaier, MD ^f, Nahla Jerbi, MD ^f, Imen Zemni, MD ^g, Wahid Bouida, MD ^a,^c, Mohamed Habib Grissa, MD ^a,^c, Hamdi Boubaker, MD ^a,^c, Riadh Boukef, MD ^a,^d, Mohamed Amine Msolli, MD ^a,^c, Semir Nouira, MD ^a,^c,^⁎
^a Research Laboratory LR12SP18, Monastir University, Monastir, Tunisia
^b Emergency Department, Haj Ali Soua Regional Hospital, Monastir, Tunisia
^c Emergency Department, Fattouma Bourguiba University Hospital, Monastir, Tunisia
^d Emergency Department, Sahloul University Hospital, Sousse, Tunisia
^e Emergency Department, Hached University Hospital, Sousse, Tunisia
^f Emergency Department, Taher Sfar University Hospital, Mahdia, Tunisia
^g Department of Epidemiology and Preventive Medicine, Fattouma Bourguiba University Hospital, Monastir, Tunisia

^∗Corresponding Author.

Sous presse. Épreuves corrigées par l'auteur. Disponible en ligne depuis le Friday 19 July 2024

Abstract

Study objective

We wished to determine whether the addition of magnesium sulfate (MgSO₄) or lidocaine to diclofenac could improve the analgesic efficacy in emergency department (ED) patients with acute renal colic.

Methods

In this prospective, double-blinded, randomized controlled trial of patients aged 18 to 65 years with suspected acute renal colic, we randomized them to receive 75 mg intramuscular (IM) diclofenac and then intravenous (IV) MgSO_4, lidocaine, or saline solution control. Subjects reported their pain using a numerical rating scale (NRS) before drug administration and then 5, 10, 20, 30, 60, and 90 minutes afterwards. Our primary outcome was the proportion of participants achieving at least a 50% reduction in the NRS score 30 minutes after drug administration.

Results

We enrolled 280 patients in each group. A 50% or greater reduction in the NRS score at 30 minutes occurred in 227 (81.7%) patients in the MgSO₄ group, 204 (72.9%) in the lidocaine group, and 201 (71.8%) in the control group, with significant differences between MgSO₄ and lidocaine (8.8%, 95% confidence interval [CI] [1.89 to 15.7], P=.013) and between MgSO₄ and control (9.9%, 95% CI [2.95 to 16.84], P=.004). Despite this, differences between all groups at every time point were below the accepted 1.3 threshold for clinical importance. There were no observed differences between groups in the frequency of rescue analgesics and return visits to the ED for renal colic. There were more adverse events, although minor, in the MgSO₄ group.

Conclusion

Adding intravenous MgSO₄, but not lidocaine, to IM diclofenac offered superior pain relief but at levels below accepted thresholds for clinical importance.

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Plan

Introduction

Background

Importance

Goals of This Investigation

Methods

Study Design and Settings

Selection of Participants

Characteristics of Study Subjects

	Supervising editor: Steven M. Green, MD. Specific detailed information about possible conflict of interest for individual editors is available at editors.
	Author contributions: SN conceived the study and designed the trial. SN, RB, and ZM supervised the conduct of the trial and data collection. SS, CK, AS, KBHA, RJ, HY, AS, and RD undertook recruitment of participating centers and patients and managed the data, including quality control. IZ provided statistical advice on study design and analyzed the data. SN and MT drafted the manuscript, and all authors contributed substantially to its revision. SN takes responsibility for the paper as a whole.
	Data sharing statement: The entire deidentified dataset, data dictionary and analytic code for this investigation are available upon request, from the date of article publication by contacting Dr. Semir Nouira at semir.nouira.urg@gmail.com.
	All authors attest to meeting the four ICMJE.org authorship criteria: (1) Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND (2) Drafting the work or revising it critically for important intellectual content; AND (3) Final approval of the version to be published; AND (4) Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
	Funding and support: By Annals’ policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org/). This study was conducted without financial support. The authors have no conflict of interest relevant to this article to disclose.
	Trial registration number: NCT05653401.
	Please see page XX for the Editor’s Capsule Summary of this article.