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Three -Agent Preemptive Analgesia, Pregabalin-Acetaminophen-Naproxen, in Laparotomy for Cancer: A Randomized Clinical Trial.

ABSTRACT: Pain management after abdominal surgery is a critical issue in cancer patients undergoing laparotomy. Opioid analgesics commonly used postoperatively have significant side effects and can postpone restoring normal life. Administration of analgesics before the surgery by inhibiting pain cascades may be an effective method for more efficient pain control.This study aimed to investigate the effect of the preemptive use of oral pregabalin-acetaminophen-naproxen on pain control and morphine consumptions in cancer patients undergoing laparotomy.A total of 40 cancer patients scheduled for open abdominal surgery were randomized into the two groups. one group received combination of pregabalin 150 mg, acetaminophen 1 g and naproxen 250 mg (the PAN group) an hour before laparotomy. Following the surgery, morphine was administered on a protocolized schedule based on patients' demand for pain control. Postoperative pain level was assessed using universal pain assessment tool (UPAT) at 0, 2, 4, 6, 12, 24 and 48 hours after the operation. The postoperative morphine dose and complications were noted. Data were analyzed using SPSS version 16.Patients in the PAN group had significantly lower UPAT scores at 0, 2, 4, 6, 12, 24 and 48 hours after the surgery than those in the control group (P = 0.008, 0.021, 0.008, 0.047, 0.004, 0.001, and 0.001). The mean dose of postoperative morphine consumption in the PAN group was 37% less than the control group (P = 0.001). The complications were not significantly different between the two groups.Preemptive use of pregabalin-acetaminophen-naproxen decreases intensity of pain and morphine consumption in the cancer patients after laparotomy without significant complications.

SUBMITTER: Amiri H

PROVIDER: S-EPMC5556332 | biostudies-other | 2017 Apr

REPOSITORIES: biostudies-other

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Project description:BackgroundThe efficacy of intravenous (IV) acetaminophen compared with its oral formulation for postoperative analgesia is unknown. We hypothesized that the addition of acetaminophen to a multimodal analgesia regimen would provide improved pain management in patients after total knee arthroplasty (TKA) and that the effect of acetaminophen would be variable based on the route of delivery.MethodsThe study was a single-center, randomized, double-blinded, placebo-controlled clinical trial on the efficacy of IV vs oral acetaminophen in patients undergoing unilateral TKA. One hundred seventy-four subjects were randomized to one of the 3 groups: IV acetaminophen group (IV group, n = 57) received 1 g IV acetaminophen and oral placebo before postanesthesia care unit (PACU) admission; oral acetaminophen group (PO group, n = 58) received 1 g oral acetaminophen and volume-matched IV normal saline; placebo group (Placebo group, n = 59) received oral placebo and volume-matched IV normal saline. Pain scores were obtained every 15 minutes during PACU stay. Average pain scores, maximum pain score, and pain scores before physical therapy were compared among the 3 groups. Secondary outcomes included total opiate consumption, time to PACU discharge, time to rescue analgesia, and time to breakthrough pain.ResultsThe average PACU pain score was similar in the IV group (0.56 ± 0.99 [mean ± standard deviation]) compared with the PO group (0.67 ± 1.20; P = .84) and Placebo group (0.58 ± 0.99; P = .71). Total opiate consumption at 6 hours (0.47 mg hydromorphone equivalents ± 0.56 vs 0.54 ± 0.53 vs 0.54 ± 0.61; P = .69) and at 24 hours (1.25 ± 1.30 vs 1.49 ± 1.34 vs 1.36 ± 1.31; P = .46) were also similar between the IV, PO, and Placebo groups. No significant differences were found between all groups for any other outcome.ConclusionNeither IV nor oral acetaminophen provides additional analgesia in the immediate postoperative period when administered as an adjunct to multimodal analgesia in patients undergoing TKA in the setting of a spinal anesthetic.

Project description:BackgroundAtogepant is an oral calcitonin gene-related peptide (CGRP) receptor antagonist in development for preventive treatment of migraine.ObjectiveTo evaluate potential pharmacokinetic drug-drug interactions (DDIs), safety and tolerability of atogepant co-administered with acetaminophen or naproxen in healthy participants.MethodsThis open-label, randomized, five-way crossover, single-center, phase 1 DDI trial randomized healthy adult participants to one of ten intervention sequences to receive single-dose 60 mg atogepant, 1000 mg acetaminophen, 500 mg naproxen, or co-administrations of atogepant with acetaminophen or naproxen, with 7-day washout periods between interventions. Potential DDIs were assessed using geometric mean ratios and 90% confidence intervals (CIs) calculated from maximum plasma drug concentrations (Cmax) and area under the plasma drug concentration-time curves (AUCs) for co-administered medications versus medications administered alone. Secondary pharmacokinetic parameters [time to Cmax (tmax), terminal elimination half-life (t1/2), volume of distribution during terminal phase (VZ/F), total body clearance (CL/F)], and safety were evaluated.ResultsForty participants enrolled; 35 (87.5%) completed the trial. Atogepant Cmax was unchanged, AUC0-t and AUC0-∞ both increased 13%, and tmax and t1/2 were unchanged when co-administered with acetaminophen; and acetaminophen Cmax decreased 11%, AUC0-t and AUC0-∞ both decreased 6%, and tmax and t1/2 were unchanged when co-administered with atogepant. Atogepant mean (SD) Vz/F and CL/F were 369.45 (255.68) L and 18.88 (9.28) L/h, respectively, when administered alone and 297.56 (196.01) L and 16.33 (6.11) L/h when co-administered with acetaminophen. Atogepant Cmax was unchanged, AUC0-t and AUC0-∞ both decreased 1%, and tmax and t1/2 were unchanged when co-administered with naproxen; and naproxen Cmax decreased 6%, AUC0-t and AUC0-∞ both decreased 2%, and tmax and t1/2 were unchanged when co-administered with atogepant. Atogepant mean (SD) Vz/F and CL/F were 359.61 (247.99) L and 18.80 (7.78) L/h, respectively, when co-administered with naproxen. Treatment-emergent adverse events (TEAEs) occurred at rates of 5.6-21.1% across interventions. The most commonly reported TEAEs were oropharyngeal pain (n = 2, with atogepant; not treatment related) and nausea (n = 2, with atogepant/acetaminophen; treatment related).ConclusionCo-administration of 60 mg atogepant with 1000 mg acetaminophen or 500 mg naproxen was safe and well tolerated in healthy participants, and no DDIs were observed.

Project description:BackgroundOpioid analgesics continue to be prescribed after ambulatory surgery despite untoward adverse effects, risk of overdose, and association with substance use disorder.Purpose/hypothesisThe purpose was to investigate the use of a novel system to provide scheduled and simultaneous dosing of acetaminophen, celecoxib, and pregabalin after anterior cruciate ligament reconstruction (ACLR). It was hypothesized that this system would markedly reduce pain and opioid use compared with existing best practice.Study designRandomized controlled trial; Level of evidence, 1.MethodsIncluded were 100 patients scheduled for elective, primary ACLR using allograft or hamstring tendon autograft. Selection criteria included age between 18 and 65 years and weight between 65 and 120 kg. Exclusion criteria were a known allergy to any drug used in the study or the use of opioid analgesics before surgery. Patients in the intervention group received a blister pack with scheduled, simultaneous doses of acetaminophen, celecoxib, and pregabalin; patients were also given oxycodone 5 mg as needed for breakthrough pain. Patients in the control group were prescribed ibuprofen and oxycodone 5 mg/acetaminophen 325 mg as needed for pain. The primary outcome measure was pain. Secondary outcomes were nausea, itching, and daily oxycodone use. Patients were asked to quantify their average pain at rest, nausea, and itching on an 11-point verbal scale (from 0 to 10). These data were recorded for 6 days during daily telephone contacts with patients after hospital discharge.ResultsCumulative results for 6 days showed significantly lower values in the intervention group compared with the control group for pain (median [interquartile range], 28 [14-35] vs 35 [28-41], respectively; P = .009) and oxycodone use (median [interquartile range] number of tablets, 0 [0-2] vs 8 [1.25-16], respectively; P < .001). Based on these data, the upper tolerance limits for the number of oxycodone tablets required by 90% of patients in the intervention and control groups were 8 tablets and 30 tablets, respectively. Cumulative results for nausea and itching were also significantly lower for the intervention group. Most patients in the intervention group used no opioids during recovery.ConclusionSimultaneous dosing of 3 nonopioid analgesics resulted in reduced postoperative pain and markedly lower opioid use.RegistrationNCT04015908 (ClinicalTrials.gov identifier).

Project description:BackgroundPregabalin is worldwidely licensed for the treatment of a variety of pain syndromes and supposed to be a potential candidate for the centrally mediated abdominal pain syndrome (CAPS).ObjectivesTo investigate the efficacy of pregabalin on nociceptive and emotional symptoms in CAPS patients.DesignThis is an open-label randomized controlled trial.MethodsCAPS patients were randomized to receive pregabalin 75 mg (P group), pinaverium bromide 50 mg (PB group), or pregabalin combined pinaverium bromide regimen (P + PB group) three times daily for 4 weeks. Questionnaires were completed biweekly. The primary outcomes were defined as the average abdominal pain scores of severity and frequency at weeks 2 and 4. Secondary outcomes included the reduction in abdominal pain scores, Somatic Self-rating Scale (SSS), Patient Health Questionnaire-15 (PHQ-15), and Generalized Anxiety Disorder Scale 7 (GAD-7) scales obtained at the end of trial to the baseline.ResultsTotally, 102 eligible patients were recruited and randomized. The mean severity scores of abdominal pain were 1.39 ± 1.28, 0.97 ± 1.43 versus 2.91 ± 1.44 (p < 0.0001) in P or PB + P group versus PB group at week 2 and were 0.90 ± 1.21, 1.28 ± 1.87 versus 2.74 ± 1.75 (p < 0.0001) at week 4. The mean frequency scores were 2.55 ± 2.55, 2.03 ± 2.80 versus 5.12 ± 2.09(p < 0.0001) in P or PB + P group versus PB group at week 2 and were 1.72 ± 2.46, 2.00 ± 2.90 versus 4.55 ± 2.55 (p < 0.0001) at week 4. When comparing the changes in SSS, PHQ-15, and GAD-7 scores, patients accepting pregabalin or pregabalin combination regimen reported a more decrease than pinaverium bromide recipients (p = 0.0002, p = 0.0002, and p = 0.0033).ConclusionThis trial suggests that pregabalin may be beneficial for CAPS abdominal pain and concomitant somatic or anxiety symptoms.Registrationwww.chictr.org.cn (ChiCTR1900028026).

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Three -Agent Preemptive Analgesia, Pregabalin-Acetaminophen-Naproxen, in Laparotomy for Cancer: A Randomized Clinical Trial.

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