Subcutaneous versus intravenous tramadol for extremity injury with moderate pain in the emergency department: a randomised controlled noninferiority trial.
Journal
European journal of emergency medicine : official journal of the European Society for Emergency Medicine
ISSN: 1473-5695
Titre abrégé: Eur J Emerg Med
Pays: England
ID NLM: 9442482
Informations de publication
Date de publication:
01 Oct 2023
01 Oct 2023
Historique:
medline:
1
9
2023
pubmed:
5
6
2023
entrez:
5
6
2023
Statut:
ppublish
Résumé
Musculoskeletal trauma is a common presentation in the emergency department (ED). Tramadol as an analgesic has been recommended by pain management guidelines for musculoskeletal pain. Parenteral tramadol in the ED is commonly administered intravenously. Subcutaneously administered tramadol may have other advantages such as easier and faster preparation, avoids the need for intravenous (i.v.) access, and reduces the incidence of respiratory and gastrointestinal effects. However, studies comparing subcutaneous (s.c.) and i.v. tramadol for the management of acute moderate pain in patients with extremity injury are lacking. The objective of this study was to compare the clinical efficacy of s.c. tramadol vs. i.v. tramadol in patients with moderate pain due to extremity injury in the ED. This non-inferiority randomized controlled trial included adult patients presented to an academic, tertiary hospital ED with moderate pain (pain score of 4-6 on the visual analog scale) due to extremity injury. Intervention patients stratified to pain score were randomized to receive 50 mg of i.v. or s.c. tramadol. Primary outcome measure was the difference in the pain score reduction at 30 min after tramadol administration between the two groups. The noninferiority null hypothesis was that the therapeutic difference in terms of pain score reduction of more than 0.8 exists between the two treatment groups at the endpoint. In total 232 patients were randomized to i.v. ( n = 115) or s.c. ( n = 117). Although 225 were analyzed in the per-protocol population (i.v. = 113; s.c. = 112). The baseline median pain score was 6 (IQR, 5-6). Median pain score reduction at 30 min after administration was 2 (IQR, 1-3) in the IV group vs. 2 (IQR, 1-2) in the s.c. group with a median difference of 0 (IQR, 0-0), which was below the prespecified noninferiority margin of 0.8. Adverse events in the i.v. group were higher compared to the s.c. group (33.6% vs. 8.9%, P ≤ 0.001). The s.c. tramadol is noninferior to i.v. tramadol in the treatment of moderate pain from extremity injuries.
Sections du résumé
BACKGROUND AND IMPORTANCE
BACKGROUND
Musculoskeletal trauma is a common presentation in the emergency department (ED). Tramadol as an analgesic has been recommended by pain management guidelines for musculoskeletal pain. Parenteral tramadol in the ED is commonly administered intravenously. Subcutaneously administered tramadol may have other advantages such as easier and faster preparation, avoids the need for intravenous (i.v.) access, and reduces the incidence of respiratory and gastrointestinal effects. However, studies comparing subcutaneous (s.c.) and i.v. tramadol for the management of acute moderate pain in patients with extremity injury are lacking.
OBJECTIVE
OBJECTIVE
The objective of this study was to compare the clinical efficacy of s.c. tramadol vs. i.v. tramadol in patients with moderate pain due to extremity injury in the ED.
DESIGN, SETTINGS, AND PARTICIPANTS
METHODS
This non-inferiority randomized controlled trial included adult patients presented to an academic, tertiary hospital ED with moderate pain (pain score of 4-6 on the visual analog scale) due to extremity injury. Intervention patients stratified to pain score were randomized to receive 50 mg of i.v. or s.c. tramadol.
OUTCOMES MEASURE AND ANALYSIS
METHODS
Primary outcome measure was the difference in the pain score reduction at 30 min after tramadol administration between the two groups. The noninferiority null hypothesis was that the therapeutic difference in terms of pain score reduction of more than 0.8 exists between the two treatment groups at the endpoint.
MAIN RESULTS
RESULTS
In total 232 patients were randomized to i.v. ( n = 115) or s.c. ( n = 117). Although 225 were analyzed in the per-protocol population (i.v. = 113; s.c. = 112). The baseline median pain score was 6 (IQR, 5-6). Median pain score reduction at 30 min after administration was 2 (IQR, 1-3) in the IV group vs. 2 (IQR, 1-2) in the s.c. group with a median difference of 0 (IQR, 0-0), which was below the prespecified noninferiority margin of 0.8. Adverse events in the i.v. group were higher compared to the s.c. group (33.6% vs. 8.9%, P ≤ 0.001).
CONCLUSIONS
CONCLUSIONS
The s.c. tramadol is noninferior to i.v. tramadol in the treatment of moderate pain from extremity injuries.
Identifiants
pubmed: 37276052
doi: 10.1097/MEJ.0000000000001047
pii: 00063110-990000000-00066
doi:
Substances chimiques
Tramadol
39J1LGJ30J
Analgesics, Opioid
0
Types de publication
Randomized Controlled Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
331-340Informations de copyright
Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.
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