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Intravenous Paracetamol Versus Patient-Controlled Analgesia With Morphine for the Pain Management Following Diagnostic Knee Arthroscopy in Trauma Patients: A Randomized Clinical Trial.

ABSTRACT: 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.

SUBMITTER: Hashemi SM

PROVIDER: S-EPMC4733531 | biostudies-other | 2015 Dec

REPOSITORIES: biostudies-other

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Intravenous Paracetamol Versus Patient-Controlled Analgesia With Morphine for the Pain Management Following Diagnostic Knee Arthroscopy in Trauma Patients: A Randomized Clinical Trial.

Hashemi Seyed Masoud SM Esmaeelijah Aliakbar A Golzari Samad S Keyhani Sohrab S Maserrat Azita A Mohseni Gholamreza G Ardehali Seyed Hosein SH

Archives of trauma research 20151121 4

<h4>Background</h4>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 ...[more]

PMID: 26848478

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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.

Dataset Information

Intravenous Paracetamol Versus Patient-Controlled Analgesia With Morphine for the Pain Management Following Diagnostic Knee Arthroscopy in Trauma Patients: A Randomized Clinical Trial.

Publications

Intravenous Paracetamol Versus Patient-Controlled Analgesia With Morphine for the Pain Management Following Diagnostic Knee Arthroscopy in Trauma Patients: A Randomized Clinical Trial.

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