Intravenous acetaminophen with morphine versus intravenous morphine alone for acute pain in the emergency room: protocol for a multicenter, randomized, placebo-controlled, double-blinded study (ADAMOPA).

BACKGROUND: In emergency medicine, pain is a frequent reason for consultation. However, there is a great variation in its management which is often insufficient. The use intravenous morphine alone or multimodal analgesia with paracetamol is recommended for severe pain. But robust data are lacking to justify the association of paracetamol with morphine versus morphine alone for pain management in the emergency room (ER). The aim of our study is therefore to assess if in patients with acute pain of moderate to severe intensity with a numerical verbal scale (NVS) ≥5 in the ER, the intravenous administration of morphine alone is not inferior to the administration of intravenous morphine combined with paracetamol at 30 min from the first administration of the study drug. METHODS: ADAMOPA is a prospective, non-inferiority, multicenter, placebo-controlled, parallel-group, randomized (1:1), double-blind trial. Subjects will be enrolled in the ER if they experience moderate to severe, acute, non-traumatic, and traumatic pain, defined as an NVS ≥5. The primary endpoint will be the between-group difference in mean change in NVS pain scores among patients receiving the combination of intravenous morphine plus paracetamol or intravenous morphine given alone, measured from the time before administration of the study medication to 30 min later. DISCUSSION: This trial will determine the clinical utility of the association of paracetamol with morphine for pain management in the emergency room. The ADAMOPA trial will be conducted in accordance with the International Council on Harmonization Good Clinical Practices. TRIAL REGISTRATION: EudraCT number: 2019-002149-39. CLINICALTRIALS: gov identifier: NCT04148495. Date of trial registration: November 1, 2019.

Is intravenously administered, subdissociative-dose KETAmine non-inferior to MORPHine for prehospital analgesia (the KETAMORPH study): study protocol for a randomized controlled trial.

BACKGROUND: Acute pain is a common condition among prehospital patients and prompt management is pivotal. Opioids are the most frequently analgesics used in the prehospital setting. However, opioids are highly addictive, and some patients may develop opioid dependence, even when they are exposed to brief opioid treatments. Therefore, alternative non-opioid analgesia should be developed to manage pain in the prehospital setting. Used at subdissociative doses, ketamine, a noncompetitive N-methyl-D-aspartate and glutamate receptor antagonist, provides analgesic effects accompanied by preservation of protective airway reflexes. In this context, we will carry out a randomized controlled, open-label, multicenter trial to compare a subdissociative dose of ketamine to morphine to provide pain relief in the prehospital setting, in patients with traumatic and non-traumatic pain. METHODS/DESIGN: This will be a multicenter, single-blind, randomized controlled trial. Consecutive adults will be enrolled in the prehospital setting if they experience moderate to severe, acute, non-traumatic and traumatic pain, defined as a numeric rating scale score greater or equal to 5. Patients will be randomized to receive ketamine or morphine by intravenous push. The primary outcome will be the between-group difference in mean change in numeric rating scale pain scores measured from the time before administration of the study medication to 30 min later. DISCUSSION: This upcoming randomized clinical trial was design to assess the efficacy and safety of ketamine, an alternative non-opiate analgesia, to manage non-traumatic and traumatic pain in the prehospital setting. We aim to provide evidence to change prescribing practices to reduce exposition to opioids and the subsequent risk of addiction. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03236805 . Registered on 2 August 2017.

Withholding and withdrawing life-support therapy in an Emergency Department: prospective survey.

OBJECTIVES: Few studies have focused on decisions to withdraw or withhold life-support therapies in the emergency department. Our objectives were to identify clinical situations where life-support was withheld or withdrawn, the criteria used by physicians to justify their decisions, the modalities necessary to implement these decisions, patient disposition, and outcome. DESIGN AND SETTING: Prospective unicenter survey in an Emergency Department of a tertiary care teaching hospital. PATIENTS: All non-trauma patients (n=119) for whom a decision to withhold or withdraw life-sustaining treatments was taken between January and September 1998. MAIN OUTCOME MEASURES: Choice of criteria justifying the decision to withhold or withdraw life-sustaining treatments, time interval from ED admission to the decision; type of decision implemented, outcome. RESULTS: Fourteen thousand eight hundred and seventy-five non-trauma patients were admitted during the study period, 119 were included, mean age 75+/-13 years. Resuscitation procedures were instituted for 96 (80%) patients before a subsequent decision was taken. Physicians chose on average 6+/-2 items to justify their decision; the principal acute medical disorder and futility of care were the two criteria most often used. Median time interval to reach the decision was 187 min. Withdrawal involved 37% of patients and withholding 63% of patients. The family was involved in the decision-making process in 72% of patients. The median time interval from the decision to death was 16 h (5 min to 140 days). CONCLUSION: Withdrawing and withholding life-support therapy involved elderly patients with underlying chronic cardiopulmonary disease or metastatic cancer or patients with acute non-treatable illness.

Efficacy of alteplase thrombolysis for ED treatment of pulmonary embolism with shock.

Our objective was to assess efficacy and tolerance of thrombolysis using 0.6 mg/kg of Alteplase in patients with massive pulmonary embolism defined as the association of a pulmonary embolism with shock. We retrospectively included 21 patients presenting with a massive pulmonary embolism confirmed by either scintigraphy or spiral computed tomography. Patients were treated on the basis of a standard rationale followed by thrombolysis with 0.6 mg/kg Alteplase over a period of 15 minutes. Hospital mortality, vital signs before and 2 hours after thrombolysis, and incidence of hemorrhagic events were recorded. Five patients (23.8%) died, 4 of these deaths occurred during the first 4 hours after hospital admission. Systolic and diastolic blood pressure (Sp02) were significantly improved 2 hours after the beginning of thrombolysis. Five minor hemorrhagic events occurred. This study demonstrates that for patients with pulmonary embolism and shock, a bolus treatment with Alteplase is potentially effective and well tolerated.