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Efficacy of Intravenous Paracetamol Versus Intravenous Morphine in Acute Limb Trauma.

ABSTRACT: BACKGROUND:Efficient pain management is one of the most important components of care in the field of emergency medicine. OBJECTIVES:This study was conducted to compare intravenous paracetamol and intravenous morphine sulfate for acute pain reduction in patients with limb trauma. PATIENTS AND METHODS:In a randomized double-blinded clinical trial, all patients (aged 18 years and older) with acute limb trauma and a pain score of greater than 3/10 in the emergency department were recruited; they received either 1 g intravenous paracetamol or 0.1 mg/kg intravenous morphine sulfate over 15 minutes. The primary outcome was the pain score measured on a numerical rating scale at 0, 15 and 30 minutes after commencing drug administration. The requirement for rescue analgesia and the frequency of adverse reactions were also recorded. RESULTS:Sixty patients randomly received either IV paracetamol (n = 30) or IV morphine (n = 30). The mean reduction in numerical rating scale pain intensity scores at 30 minutes was 3.86 (± 1.61) for paracetamol, and 2.16 (± 1.39) for morphine. However, pain relief was significantly higher in the paracetamol group compared to the morphine group (P < 0.001). Four patients in the paracetamol group and 15 patients in the morphine group needed rescue analgesia and the difference was significant (P = 0.05). CONCLUSIONS:Intravenous paracetamol appears to provide better analgesia than intravenous morphine in acute limb trauma. Further larger studies are required.

SUBMITTER: Jalili M

PROVIDER: S-EPMC4869432 | biostudies-literature | 2016 Feb

REPOSITORIES: biostudies-literature

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Efficacy of Intravenous Paracetamol Versus Intravenous Morphine in Acute Limb Trauma.

Jalili Mohammad M Mozaffarpour Noori Ali A Sedaghat Mojtaba M Safaie Arash A

Trauma monthly 20160206 1

<h4>Background</h4>Efficient pain management is one of the most important components of care in the field of emergency medicine.<h4>Objectives</h4>This study was conducted to compare intravenous paracetamol and intravenous morphine sulfate for acute pain reduction in patients with limb trauma.<h4>Patients and methods</h4>In a randomized double-blinded clinical trial, all patients (aged 18 years and older) with acute limb trauma and a pain score of greater than 3/10 in the emergency department we ...[more]

PMID: 27218042

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Project description:BackgroundIntravenous morphine (IVM) is the most common strong analgesic used in trauma, but is associated with a clear time limitation related to the need to obtain an access route. The intranasal (IN) route provides easy administration with a fast peak action time due to high vascularization and the absence of first-pass metabolism. We aimed to determine whether IN sufentanil (INS) for patients presenting to an emergency department with acute severe traumatic pain results in a reduction in pain intensity non-inferior to IVM.Methods and findingsIn a prospective, randomized, multicenter non-inferiority trial conducted in the emergency departments of 6 hospitals across France, patients were randomized 1:1 to INS titration (0.3 μg/kg and additional doses of 0.15 μg/kg at 10 minutes and 20 minutes if numerical pain rating scale [NRS] > 3) and intravenous placebo, or to IVM (0.1 mg/kg and additional doses of 0.05 mg/kg at 10 minutes and 20 minutes if NRS > 3) and IN placebo. Patients, clinical staff, and research staff were blinded to the treatment allocation. The primary endpoint was the total decrease on NRS at 30 minutes after first administration. The prespecified non-inferiority margin was -1.3 on the NRS. The primary outcome was analyzed per protocol. Adverse events were prospectively recorded during 4 hours. Among the 194 patients enrolled in the emergency department cohort between November 4, 2013, and April 10, 2016, 157 were randomized, and the protocol was correctly administered in 136 (69 IVM group, 67 INS group, per protocol population, 76% men, median age 40 [IQR 29 to 54] years). The mean difference between NRS at first administration and NRS at 30 minutes was -4.1 (97.5% CI -4.6 to -3.6) in the IVM group and -5.2 (97.5% CI -5.7 to -4.6) in the INS group. Non-inferiority was demonstrated (p < 0.001 with 1-sided mean-equivalence t test), as the lower 97.5% confidence interval of 0.29 (97.5% CI 0.29 to 1.93) was above the prespecified margin of -1.3. INS was superior to IVM (intention to treat analysis: p = 0.034), but without a clinically significant difference in mean NRS between groups. Six severe adverse events were observed in the INS group and 2 in the IVM group (number needed to harm: 17), including an apparent imbalance for hypoxemia (3 in the INS group versus 1 in the IVM group) and for bradypnea (2 in the INS group versus 0 in the IVM group). The main limitation of the study was that the choice of concomitant analgesics, when they were used, was left to the discretion of the physician in charge, and co-analgesia was more often used in the IVM group. Moreover, the size of the study did not allow us to conclude with certainty about the safety of INS in emergency settings.ConclusionsWe confirm the non-inferiority of INS compared to IVM for pain reduction at 30 minutes after administration in patients with severe traumatic pain presenting to an emergency department. The IN route, with no need to obtain a venous route, may allow early and effective analgesia in emergency settings and in difficult situations. Confirmation of the safety profile of INS will require further larger studies.Trial registrationClinicalTrials.gov NCT02095366. EudraCT 2013-001665-16.

Project description:Most patients undergoing outpatient surgeries have the unpleasant experience of high level pain after surgery. Compared with open surgeries, arthroscopic procedures are less painful; however, inadequate pain management could be associated with significant concerns. Opioids alone or in combination with local anesthetics are frequently used for diminishing postoperative pain using intravenous or epidural infusion pumps. Despite morphine various disadvantages, it is commonly used for controlling pain after surgery.The aim of this study was to compare intravenous paracetamol and patient-controlled analgesia (PCA) with morphine for the pain management following diagnostic knee arthroscopy in trauma patients.Sixty trauma patients who were scheduled to undergo knee arthroscopy were randomly divided into two groups. Patients immediately received intravenous infusion of 1 g paracetamol within 15 minutes after surgery and every 6 hours to 24 hours in the paracetamol group. The patient-controlled analgesia group received morphine through PCA infusion pump at 2 mL/h base rate and 1mL bolus every 15 minutes. Pain level, nausea and vomiting, and sedation were measured and recorded during entering the recovery, 15 and 30 minutes after entering the recovery, 2, 6, and 24 hours after starting morphine pump infusion in the morphine and paracetamol in the paracetamol groups.There was no significant difference regarding the pain level at different times after entering the recovery between the two groups. No one from the paracetamol group developed drug complications. However, 22.3% in the PCA morphine suffered from postoperative nausea; there was a statistically significant difference regarding the sedation level, nausea, and vomiting at various times between the two groups.Intravenous administration of paracetamol immediately after knee arthroscopy improved postoperative pain, decreased analgesic administration, maintained stable hemodynamic parameters, had no complications related to opiates, no nausea and vomiting, and increased patient satisfaction and comfort in comparison to PCA with morphine.

Project description:Purpose:Opioid analgesics remain the cornerstone of treatment for severe trauma pain in the emergency setting, but there are barriers to their use. This post hoc analysis of a previously reported trial (MEDITA) investigated the efficacy and safety of low-dose methoxyflurane versus intravenous (IV) morphine for severe trauma pain. Patients and Methods:MEDITA was a Phase IIIb, randomized, active-controlled, parallel-group, open-label study in Italian pre-hospital units and emergency departments (EudraCT: 2017-001565-25; NCT03585374). Adult patients (N=272) with moderate-to-severe trauma pain (score ?4 on the Numerical Rating Scale [NRS]) were randomized 1:1 to inhaled methoxyflurane (3 mL) or standard analgesic treatment (SAT; IV paracetamol 1g or ketoprofen 100mg for moderate pain [NRS 4-6] and IV morphine 0.1mg/kg for severe pain [NRS ?7]). Analyses were performed for the severe pain subgroup. The primary efficacy variable was the overall change from baseline in visual analog scale (VAS) pain intensity at 3, 5 and 10min post-randomization. Non-inferiority of methoxyflurane versus morphine was concluded if the upper 95% confidence interval (CI) for the treatment difference was <1; superiority was concluded if the upper 95% CI was <0. Results:Ninety-three patients (methoxyflurane: 49; SAT: 44) were included in the severe pain intention-to-treat population. The reduction in VAS pain intensity over the first 10min was superior for methoxyflurane versus morphine (adjusted mean treatment difference: -5.54mm; 95% CI: -10.49, -0.59mm; p=0.029). Median time to onset of pain relief was 9min for methoxyflurane and 15min for morphine. Patients rated treatment efficacy and physicians rated treatment practicality "Excellent" or "Very good" for more methoxyflurane-treated patients (42.8% and 67.3%) than morphine-treated patients (18.1% and 22.8%). Adverse events, all non-serious, were reported in 20.4% of methoxyflurane-treated patients and in 4.8% of morphine-treated patients. Conclusion:Methoxyflurane provided superior short-term pain relief to IV morphine in patients with severe trauma pain and offers an effective non-narcotic treatment option.

Dataset Information

Efficacy of Intravenous Paracetamol Versus Intravenous Morphine in Acute Limb Trauma.

Publications

Efficacy of Intravenous Paracetamol Versus Intravenous Morphine in Acute Limb Trauma.

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