Dataset Information

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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Publications

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:Background: Intravenous paracetamol, as an adjunct to multimodal analgesia, has been shown to successfully reduce opioid consumption after joint arthroplasty, abdominal surgery, and caesarean delivery. However, there are limited data on the opioid-sparing effect of intravenous paracetamol on lumbar disc surgery. Objectives: The aim of this study was to investigate the effectiveness and safety of intravenous paracetamol for reducing opioid consumption in lumbar disc surgery. The primary outcome was cumulative opioid consumption within 24 h postoperatively. Method: We followed the PRISMA-P guidelines and used GRADE to assess the quality of evidence. The review was registered in PROSPERO under the registration number CRD42021288168. Two reviewers conducted electronic searches in PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), Scopus, and Web of Science (Clarivate Analytics). Randomized controlled trials (RCTs) that compared the postoperative opioid consumption of intravenous paracetamol with placebo in lumbar discectomy were included. Results: Five trials comprising a total of 271 patients were included. The overall opioid consumption within 24 h postoperatively was reduced [mean difference (MD), -10.61 (95% CI, -16.00 to -5.22) mg, p = 0.0001, I2 = 90%] in patients with intravenous paracetamol. Intravenous paracetamol significantly reduced the postoperative pain scores at 1 h [MD, -2.37 (95%CI, -3.81 to -0.94), p = 0.001, I2 = 82%], 2 h [MD, -3.17 (95%CI, -3.85 to -2.48), p < 0.00001, I2 = 38%], 6 h [MD, -1.75 (95%CI, -3.10 to -0.40), p = 0.01], 12 h [MD, -0.96 (95%CI, -1.77 to -0.15), p = 0.02], and 24 h [MD, -0.97 (95%CI, -1.67 to -0.27), p = 0.006] compared with the placebo. There were no differences in postoperative adverse effects. Conclusion: Intravenous paracetamol reduced postoperative opioid consumption and decreased postoperative pain scores without increasing adverse effects. The overall GRADE quality of the evidence was rated as low to moderate. Intravenous paracetamol appears to be an applicable option as an important part of multimodal analgesia for postoperative analgesia after lumbar disc surgery. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/, CRD42021288168.

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.

Dataset Information

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

Aim

Methods

Results

Conclusions

Publications

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

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