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Randomized Trial of Intravenous Lidocaine Versus Hydromorphone for Acute Abdominal Pain in the Emergency Department.

ABSTRACT: STUDY OBJECTIVE:We compare the efficacy and safety of intravenous lidocaine with that of hydromorphone for the treatment of acute abdominal pain in the emergency department (ED). METHODS:This was a randomized, double-blind, clinical trial conducted in 2 EDs in the Bronx, NY. Adults weighing 60 to 120 kg were randomized to receive 120 mg of intravenous lidocaine or 1 mg of intravenous hydromorphone. Thirty minutes after administration of the first dose of the study drug, participants were asked whether they needed a second dose of the investigational medication to which they were randomized. Patients were also stratified according to clinical suspicion of nephrolithiasis. The primary outcome was improvement in pain scores of 0 to 10 between baseline and 90 minutes. An important secondary outcome was need for "off-protocol" parenteral analgesics, including opioids and nonsteroidal anti-inflammatory drugs. RESULTS:We enrolled 154 patients, of whom 77 received lidocaine and 77 received hydromorphone. By 90 minutes, patients randomized to lidocaine improved by a mean of 3.8 points on the 0-to-10 scale, whereas those randomized to hydromorphone improved by a mean of 5.0 points (mean difference 1.2; 95% confidence interval 0.3 to 2.2). Need for off-protocol "rescue" analgesics occurred for 39 of 77 lidocaine patients (51%) and 20 of 77 hydromorphone patients (26%) (difference 25%; 95% confidence interval 10% to 40%). Adverse events were comparable between groups. Among the subset of 22 patients with nephrolithiasis, lidocaine patients reported a mean improvement of 3.4 points on the pain scale, whereas hydromorphone patients reported a mean improvement of 6.4 points (mean difference 3.0; 95% confidence interval 0.5 to 5.5). CONCLUSION:Intravenous hydromorphone was superior to intravenous lidocaine both for general abdominal pain and a subset of patients with nephrolithiasis. A majority of patients randomly allocated to lidocaine required additional analgesics.

SUBMITTER: Chinn E

PROVIDER: S-EPMC6764530 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Randomized Trial of Intravenous Lidocaine Versus Hydromorphone for Acute Abdominal Pain in the Emergency Department.

Chinn Elliott E Friedman Benjamin W BW Naeem Farnia F Irizarry Eddie E Afrifa Freda F Zias Eleftheria E Jones Michael P MP Pearlman Scott S Chertoff Andrew A Wollowitz Andrew A Gallagher E John EJ

Annals of emergency medicine 20190226 2

<h4>Study objective</h4>We compare the efficacy and safety of intravenous lidocaine with that of hydromorphone for the treatment of acute abdominal pain in the emergency department (ED).<h4>Methods</h4>This was a randomized, double-blind, clinical trial conducted in 2 EDs in the Bronx, NY. Adults weighing 60 to 120 kg were randomized to receive 120 mg of intravenous lidocaine or 1 mg of intravenous hydromorphone. Thirty minutes after administration of the first dose of the study drug, participan ...[more]

PMID: 30819520

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Project description:Opioid titration is an effective strategy for treating pain; however, titration is generally impractical in the busy emergency department (ED) setting. Our objective was to test a rapid, two-step, hydromorphone titration protocol against usual care in older patients presenting to the ED with acute severe pain.This was a prospective, randomized clinical trial of patients 65 years of age and older presenting to an adult, urban, academic ED with acute severe pain. The study was registered at http://www.clinicaltrials.gov (NCT01429285). Patients randomized to the hydromorphone titration protocol initially received 0.5 mg intravenous hydromorphone. Patients randomized to usual care received any dose of any intravenous opioid. At 15 min, patients in both groups were asked, 'Do you want more pain medication?' Patients in the hydromorphone titration group who answered 'yes' received a second dose of 0.5 mg intravenous hydromorphone. Patients in the usual care group who answered 'yes' had their ED attending physician notified, who then could administer any (or no) additional medication. The primary efficacy outcome was satisfactory analgesia defined a priori as the patient declining additional analgesia at least once when asked at 15 or 60 min after administration of the initial opioid. Dose was calculated in morphine equivalent units (MEU: 1 mg hydromorphone = 7 mg morphine). The need for naloxone to reverse adverse opioid effects was the primary safety outcome.83.0 % of 153 patients in the hydromorphone titration group achieved satisfactory analgesia compared with 82.5 % of 166 patients in the usual care group (p = 0.91). Patients in the hydromorphone titration group received lower mean initial doses of opioids at baseline than patients in the usual care group (3.5 MEU vs. 4.7 MEU, respectively; p ? 0.001) and lower total opioids through 60 min (5.3 MEU vs. 6.0 MEU; p = 0.03). No patient needed naloxone.Low-dose titration of intravenous hydromorphone in increments of 0.5 mg provides comparable analgesia to usual care with less opioid over 60 min.

Project description:BackgroundEarly screening and accurately identifying Acute Appendicitis (AA) among patients with undifferentiated symptoms associated with appendicitis during their emergency visit will improve patient safety and health care quality. The aim of the study was to compare models that predict AA among patients with undifferentiated symptoms at emergency visits using both structured data and free-text data from a national survey.MethodsWe performed a secondary data analysis on the 2005-2017 United States National Hospital Ambulatory Medical Care Survey (NHAMCS) data to estimate the association between emergency department (ED) patients with the diagnosis of AA, and the demographic and clinical factors present at ED visits during a patient's ED stay. We used binary logistic regression (LR) and random forest (RF) models incorporating natural language processing (NLP) to predict AA diagnosis among patients with undifferentiated symptoms.ResultsAmong the 40,441 ED patients with assigned International Classification of Diseases (ICD) codes of AA and appendicitis-related symptoms between 2005 and 2017, 655 adults (2.3%) and 256 children (2.2%) had AA. For the LR model identifying AA diagnosis among adult ED patients, the c-statistic was 0.72 (95% CI: 0.69-0.75) for structured variables only, 0.72 (95% CI: 0.69-0.75) for unstructured variables only, and 0.78 (95% CI: 0.76-0.80) when including both structured and unstructured variables. For the LR model identifying AA diagnosis among pediatric ED patients, the c-statistic was 0.84 (95% CI: 0.79-0.89) for including structured variables only, 0.78 (95% CI: 0.72-0.84) for unstructured variables, and 0.87 (95% CI: 0.83-0.91) when including both structured and unstructured variables. The RF method showed similar c-statistic to the corresponding LR model.ConclusionsWe developed predictive models that can predict the AA diagnosis for adult and pediatric ED patients, and the predictive accuracy was improved with the inclusion of NLP elements and approaches.

Project description:BACKGROUND:In the perioperative period, intravenous lidocaine has been used as an opioid-sparing systemic analgesic with additional anti-inflammatory and anti-hyperalgesic properties. OBJECTIVE:The aim of this retrospective study was to review the utilization, efficacy, and safety of intravenous lidocaine on our Acute Pain Service (APS) and identify surgical and patient populations where this intervention was found to be useful. PATIENTS AND METHODS:This retrospective study was designed to assess acute pain management in patients who received an intravenous lidocaine infusion between February 2013 and December 2017. Data collected included demographics, surgery type, infusion duration, pain scores, analgesic consumption, and adverse effects. Pain scores included rest and active pain scores and were analyzed by surgical model and subgroups. Clinically important differences (CIDs) in pain were determined by changes in pain score difference of???2 (11-point scale) or???30% reduction in pain intensity. A patient was considered to have a true CID if a CID was observed with rest and/or active pain scores at both first to second (4-24 h) and first to final time point (4 h to infusion end) comparisons. RESULTS:In total, 544 patients received intravenous lidocaine during this period, and 394 were included in the final analysis. The average (±?standard deviation) duration of infusion was 68.60?±?49.52 h. Surgical specialties included gastrointestinal surgery (41%), orthopedics (28%), neurosurgery (15%), vascular surgery (10%), and others (6%). Overall, 56.1% of the study population experienced a CID, with reduced pain scores at rest and/or with activity. CIDs were also observed in patients with chronic pain (53.5%) and when intravenous lidocaine was used as a rescue technique (69.6%). Within the rescue cohort, opioid-dependent and opioid-naïve patients experienced 23.0% and 45.6% reductions, respectively, in their 8-h intravenous opioid consumption. In total, 37 patients in the study experienced transient signs of mild local anesthetic toxicity, which resolved with infusion titration (conservative) management. One serious adverse event required intervention, and the patient was successfully resuscitated. CONCLUSIONS:This retrospective study at a single institution with an APS policy for intravenous lidocaine in the postoperative period identifies benefits of intravenous lidocaine in certain surgical and patient populations. The findings need to be confirmed with further research.

Project description:BACKGROUND:Intravenous morphine titration (IVMT) is the French gold standard for opioid treatment in the emergency department (ED). Nebulized morphine titration (NMT) may represent an alternative without venous access, but it has not been adequately studied in adults. We test the hypothesis that NMT is at least as effective as IVMT to initially manage severe acute pain in the ED. METHODS/DESIGN:We designed a multicenter (10 French EDs), single-blind, randomized and controlled trial. Adults between 18 and 75?years with visual analog scale (VAS)???70/100 or numeric rating scale (NRS)???7/10 will be enrolled. We will randomize 850 patients into two groups to compare two routes of MT as long as VAS?>? 30 or NRS?>? 3. In group A (425), patients will receive an initial NMT for 5-25?min associated with titration of an intravenously (IV) administered placebo of physiologic serum (PS). In group B (425), patients will receive IVMT plus nebulized PS placebo. NMT is defined as a minimum of 1 and a maximum of 3 5-min nebulized boluses of 10?mg or 15?mg (weight???60?kg), at 10-min fixed intervals. IVMT is defined as a minimum of 1 and a maximum of 6 boluses of 2?mg or 3?mg (weight???60?kg), at 5-min fixed intervals. Nebulized placebo titration will be performed every 10?min. IV titration of PS will be performed every 5?min. In both groups, after 25?min, if VAS >?30/100 or NRS?>?3/10, routine IVMT will be continued until pain relief. Pain severity, vital signs, bronchospasm, and Ramsay score will be recorded every 5?min. The primary outcome is the rate of relief obtained 1?h from the start of drug administration. Complete pain relief in both groups will be compared with a non-inferiority design. Secondary outcomes are pain relief at 30?min (the end of NMT) and at 2?h and median pain relief. We will compare final doses, and study the feasibility and tolerance of NMT (protocol deviations, respiratory or hemodynamic depression, sedation, and minor vegetative side effects). Co-analgesia will be recorded. Discharge criteria from the ED and hospital are defined. DISCUSSION:This trial is the first multicenter randomized and controlled NMT protocol for severe pain in the ED using the titration concept. We propose an original approach of combined titration with an endpoint at 1?h and a non-inferiority design. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03257319 . Registered on 22 August 2017.

Project description:BackgroundMajor abdominal surgery is associated with endothelial glycocalyx disruption. The anti-inflammatory effects of lidocaine were recently associated with endothelial barrier protection.MethodsThis was a single-centre, parallel group, randomized, controlled, double blind, pilot trial. Forty adult patients scheduled for major abdominal surgery were included between December 2016 and March 2017 in the setting of a University Hospital in Brussels (Belgium); reasons for non-inclusion were planned liver resection and conditions associated to increased risk of local anesthetics systemic toxicity. Patients were randomized to receive either lidocaine by continuous intravenous administration or an equivalent volume of 0.9% saline. The primary endpoint was the postoperative syndecan-1 concentration (difference between groups). Near-infrared spectroscopy of the thenar eminence in association with the vascular occlusion test, and contemporary analysis of flow-mediated dilation of the brachial artery were the secondary outcomes, along with haemodynamic data. Blood samples and data were collected before surgery (T0), and at 1-3 h (T1) and 24 h (T2) post-surgery.ResultsSyndecan-1 concentration increased significantly post-surgery (P < 0.001), but without any difference between groups. The near-infrared spectroscopy-derived and flow-mediated dilation-derived variables showed minor changes unrelated to group assignment. Compared with the placebo group, the intervention group had a significantly lower peri-operative mean arterial pressure and cardiac index, despite equally conducted goal-directed haemodynamic management. Postoperative lactate concentrations were similar between groups.ConclusionsLidocaine failed to have any effect on endothelial function. Since in comparisons to other types of clinical situations, syndecan-1 was only slightly upregulated, endothelial dysfunction after major abdominal surgery might be overestimated.Trial registration« ISRCTN Registry » identifier: ISRCTN63417725. Date: 15/06/2020. Retrospectively registered.

Project description:OBJECTIVE:Intranasal fentanyl (INF) quickly and noninvasively relieves severe pain, whereas intravenous hydromorphone (IVH) reliably treats severe cancer pain but requires vascular access. The trial evaluated the efficacy of INF relative to IVH for treating cancer patients with severe pain in an emergency department (ED) setting. METHODS:We randomized 82 patients from a comprehensive cancer center ED to receive INF (n = 42) or IVH (n = 40). Eligible patients reported severe pain at randomization (?7, scale: 0 "none" to 10 "worst pain"). We conducted non-inferiority comparisons (non-inferiority margin = 0.9) of pain change from treatment initiation (T0) to one hour later (T60). T0 pain ratings were unavailable; therefore, we estimated T0 pain by comparing 1) T60 ratings, assuming similar group T0 ratings; 2) pain change, estimating T0 pain = randomization ratings, and 3) pain change, with T0 pain = 10 (IVH group) or T0 pain = randomization rating (INF group). RESULTS:At T60, the upper 90% confidence limit (CL) of the mean log-transformed pain ratings for the INF group exceeded the mean IVH group rating by 0.16 points (>pain). Substituting randomization ratings for T0 pain, the lower 90% CL of mean pain change in the INF group extended 0.32 points below (<pain relief) mean change in the IVH group. Finally, assuming all subjects in the IVH group had maximum pain at T0 and that T0 pain for the INF group remained unchanged from randomization, the lower bound of the 90% CL for mean pain decrease in the INF group extended 1.37 points below (<pain relief) mean decrease in the IVH group. Time (minutes) from randomization until T0 was longer for the IVH (Median 23, IQR 12) versus INF (Median 15, IQR 11) group (P<0.001). CONCLUSIONS:Two of three analyses supported non-inferiority of INF versus IVH, while one analysis was inconclusive. Compared to IVH, INF had the advantage of shorter time to administration. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02459964.

Dataset Information

Randomized Trial of Intravenous Lidocaine Versus Hydromorphone for Acute Abdominal Pain in the Emergency Department.

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Randomized Trial of Intravenous Lidocaine Versus Hydromorphone for Acute Abdominal Pain in the Emergency Department.

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