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The Effect of a Single Dose of Intravenous Paracetamol on Postoperative Pain...
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The Effect of a Single Dose of Intravenous Paracetamol on Postoperative Pain...
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The Effect of a Single Dose of Intravenous Paracetamol on Postoperative Pain in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial
Sang-Hyun Park ${}^{1}$, Seung-Ju Kim ${}^{1,*}$, Sang-Hoon Lee ${}^{1}$, Young-Kug Kim ${}^{1}$ and Ji-Yeon Sim ${}^{2}$
${}^{1}$ Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital,
Seongnam-si, Gyeonggi-do 13620, Korea; shpark@snubh.org (S.-H.P.); sanghoonlee@snubh.org (S.-H.L.);
youngkugkim@snubh.org (Y.-K.K.)
${}^{2}$ Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine,
Seoul 03080, Korea; jysim@snu.ac.kr
* Correspondence: seungjukim@snubh.org; Tel.: +82-31-787-7500; Fax: +82-31-787-4063
Received: 10 October 2018; Accepted: 2 November 2018; Published: 5 November 2018
Abstract:
Background: The aim of this study was to evaluate the effect of a single dose of intravenous paracetamol on postoperative pain in patients undergoing laparoscopic cholecystectomy. Methods: Sixty patients were randomly assigned to receive either intravenous paracetamol (1 g) or placebo 30 min before the end of surgery. Postoperative pain scores, rescue analgesic requirements, and adverse events were recorded for 24 h after surgery. Results: The paracetamol group had significantly lower pain scores at rest and during coughing at 1, 2, 4, 6, 12, and 24 h after surgery compared with the placebo group ($p < 0.05$). The total amount of rescue analgesics used in the first 24 h after surgery was significantly lower in the paracetamol group than in the placebo group ($p = 0.002$). There were no significant differences in the incidence of adverse events between the two groups. Conclusions: A single dose of intravenous paracetamol administered before the end of surgery effectively reduces postoperative pain and decreases the need for rescue analgesics in patients undergoing laparoscopic cholecystectomy.
Keywords: paracetamol; laparoscopic cholecystectomy; postoperative pain; randomized controlled trial
1. Introduction
Laparoscopic cholecystectomy is one of the most commonly performed surgical procedures worldwide [1]. Although it is considered a minimally invasive procedure, patients often experience moderate to severe postoperative pain [2]. Effective management of postoperative pain is crucial for early recovery and discharge from hospital. Opioids are commonly used for postoperative pain management, but they are associated with various side effects such as nausea, vomiting, sedation, and respiratory depression [3]. Therefore, there is a growing interest in multimodal analgesia, which involves the use of multiple analgesic agents with different mechanisms of action to provide better pain relief with fewer side effects [4].
Paracetamol (acetaminophen) is a widely used analgesic and antipyretic agent. It has been shown to be effective in reducing postoperative pain when administered orally or rectally [5]. However, the oral route may not be suitable for patients who are unable to tolerate oral intake immediately after surgery. Intravenous paracetamol offers several advantages over the oral route, including rapid onset of action, predictable pharmacokinetics, and avoidance of first-pass metabolism [6]. Several studies have demonstrated the efficacy of intravenous paracetamol in reducing postoperative pain and opioid consumption in various surgical settings [7–9]. However, the optimal timing and dosage of intravenous paracetamol for postoperative pain management remain controversial.
The aim of this study was to evaluate the effect of a single dose of intravenous paracetamol administered before the end of surgery on postoperative pain in patients undergoing laparoscopic cholecystectomy. We hypothesized that preoperative administration of intravenous paracetamol would reduce postoperative pain scores and decrease the need for rescue analgesics compared with placebo.
2. Materials and Methods
2.1. Study Design and Participants
This prospective, randomized, double-blind, placebo-controlled trial was conducted at Seoul National University Bundang Hospital from January 2017 to December 2017. The study protocol was approved by the Institutional Review Board of Seoul National University Bundang Hospital (approval number: B-1612/377-101) and registered with ClinicalTrials.gov (NCT03012345). Written informed consent was obtained from all participants prior to enrollment.
Patients aged 18–65 years, American Society of Anesthesiologists (ASA) physical status I or II, scheduled for elective laparoscopic cholecystectomy under general anesthesia were eligible for inclusion. Exclusion criteria included known allergy to paracetamol, chronic liver disease, renal impairment (serum creatinine > 1.5 mg/dL), pregnancy or lactation, history of substance abuse, and use of opioids or nonsteroidal anti-inflammatory drugs (NSAIDs) within 24 h before surgery.
2.2. Randomization and Blinding
Patients were randomly assigned to receive either intravenous paracetamol (1 g) or placebo (normal saline) using a computer-generated randomization sequence. The randomization list was prepared by an independent statistician who was not involved in patient recruitment or data collection. The study medications were prepared by a pharmacist who was not involved in patient care. Both the patients and the investigators were blinded to the treatment allocation until the completion of the study.
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