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Randomized, controlled, multicentre clinical trial of the antipyretic effect of intravenous paracetamol in patients admitted to hospital with infection.

ABSTRACT: AIM:No randomized study has been conducted to investigate the use of intravenous paracetamol (acetaminophen, APAP) for the management of fever due to infection. The present study evaluated a new ready-made infusion of paracetamol. METHODS:Eighty patients with a body temperature onset ?38.5°C in the previous 24 h due to infection were randomized to a single administration of placebo (n = 39) or 1 g paracetamol (n = 41), and their temperature was recorded at standard intervals. Rescue medication with 1 g paracetamol was allowed. Serum samples were collected for the measurement of APAP and its metabolites. The primary endpoint was defervescence, defined as a core temperature ?37.1°C. RESULTS:During the first 6 h, defervescence was achieved in 15 (38.5%) patients treated with placebo compared with 33 (80.5%) patients treated with paracetamol 1 g (P < 0.0001). The median time to defervescence with paracetamol 1 g was 3 h. Rescue medication was given to 15 (38.5%) and five (12.2%) patients allocated to placebo and paracetamol, respectively (P = 0.007); nine (60.0%) and two (40.0%) of these patients, respectively, experienced defervescence. No further antipyretic medication was needed for patients becoming afebrile with rescue medication. Serum glucuronide-APAP concentrations were significantly greater in the serum of patients who did not experience defervescence with paracetamol. The efficacy of paracetamol was not affected by serum creatinine. No drug-related adverse events were reported. CONCLUSIONS:The 1 g paracetamol formulation has a rapid and sustainable antipyretic effect on fever due to infection. Its efficacy is dependent on hepatic metabolism.

SUBMITTER: Tsaganos T

PROVIDER: S-EPMC5346867 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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Randomized, controlled, multicentre clinical trial of the antipyretic effect of intravenous paracetamol in patients admitted to hospital with infection.

Tsaganos Thomas T Tseti Ioulia K IK Tziolos Nikolaos N Soumelas Georgios-Stefanos GS Koupetori Marina M Pyrpasopoulou Athina A Akinosoglou Karolina K Gogos Charalambos C Tsokos Nikolaos N Karagiannis Asterios A Sympardi Styliani S Giamarellos-Bourboulis Evangelos J EJ

British journal of clinical pharmacology 20161207 4

<h4>Aim</h4>No randomized study has been conducted to investigate the use of intravenous paracetamol (acetaminophen, APAP) for the management of fever due to infection. The present study evaluated a new ready-made infusion of paracetamol.<h4>Methods</h4>Eighty patients with a body temperature onset ≥38.5°C in the previous 24 h due to infection were randomized to a single administration of placebo (n = 39) or 1 g paracetamol (n = 41), and their temperature was recorded at standard intervals. Resc ...[more]

PMID: 27792836

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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:Background and objectives: The combination of non-steroidal anti-inflammatory drugs and paracetamol is widely used for pediatric postoperative pain management, although the evidence of superiority of a combination over either drug alone is insufficient. We aimed to find out if intravenous (i.v.) paracetamol in a dose of 60 mg kg-1 24 h-¹, given in addition to i.v. ketoprofen (4.5 mg kg-1 24 h-¹), improves analgesia, physical recovery, and satisfaction with postoperative well-being in children and adolescents following moderate and major general surgery. Materials and Methods: Fifty-four patients were randomized to receive either i.v. paracetamol or normal saline as a placebo in adjunct to i.v. ketoprofen. For rescue analgesia in patients after moderate surgery, i.v. tramadol (2 mg kg-¹ up two doses in 24 h), and for children after major surgery, i.v. morphine-patient-controlled analgesia (PCA) were available. The main outcome measure was the amount of opioid consumed during the first 24 h after surgery. Pain level at 1 and over 24 h, time until the resumption of normal oral fluid intake, spontaneous urination after surgery, and satisfaction with postoperative well-being were also assessed. Results: Fifty-one patients (26 in the placebo group and 25 in the paracetamol group) were studied. There was no difference in required rescue tramadol doses (n = 11 in each group) or 24-h morphine consumption (mean difference (95% CI): 0.06 (⁻0.17; 0.29) or pain scores between placebo and paracetamol groups. In patients given morphine-PCA, time to normal fluid intake was faster in the paracetamol than the placebo subgroup: median difference (95% CI): 7.5 (1.3; 13.7) h, p = 0.02. Parental satisfaction score was higher in the paracetamol than the placebo group (mean difference: ⁻1.3 (⁻2.5; ⁻0.06), p = 0.04). Conclusions: There were no obvious benefits to opioid requirement or analgesia of adding regular intravenous paracetamol to intravenous ketoprofen in used doses. However, intravenous paracetamol may contribute to faster recovery of normal functions and higher satisfaction with postoperative well-being.

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Randomized, controlled, multicentre clinical trial of the antipyretic effect of intravenous paracetamol in patients admitted to hospital with infection.

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Randomized, controlled, multicentre clinical trial of the antipyretic effect of intravenous paracetamol in patients admitted to hospital with infection.

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