DOI: 10.6084/m9.figshare.22348558
title: Intranasal Sufentanil vs oral/IV opioid for severe traumatic pain dataset

description: Study Design. A prospective open label study of approximatively one hundred seventy two patients admitted to the ED for severe traumatic pain and needing opioid treatment. Patients will be included only if presenting with a VAS of 7 or above. All patients will receive a standardized backbone level-1 treatment with oral or intravenous acetaminophen and non-steroidal anti-inflammatory drugs according to the local pain protocol. Patient allergies, chronic illnesses and previous conditions will be taken into account to decide the optimal level-1 analgesia. Patients will be randomized, before receiving any pain medication, to receive intranasal sufentanil (intervention) or opioids (control) according to standard local protocol (oral oxycodone or intravenous morphine according to physician judgment). At 15 to 20 minutes patients will be re-assessed, their VAS will be revaluated and, if needed, supplemental analgesia will be offered to the patient. Patient will be followed for one hour or until patient discharge, whichever comes first. Study population and selection criteria. All aspects of the study and waiver of a consent form will be approved by our Ethical Board prior to implementation. The study will be registered in Clinical trials before enrolling the first patient. All patients with post-traumatic pain in the limbs the spine or the chest, after application of the inclusion and exclusion criteria, with an indication to receive opioids, given a VAS score of 7 or above, will be included in the study. Included participants that will be admitted to CHU Saint Pierre will be retained in the study and care data will be collected according our protocol. Inclusion criteria will be a traumatic limb, chest or spine injury in a subject aged between 18 to 99 years old with an indication to receive opioid treatment. Subjects will be excluded from the study if younger than 18 years old, if pregnant or if prisoners at study inclusion. Patient with a history of chronic or acute opiate drug use, intake any opiate less than 8 hours before admission, alcohol intoxication, allergy or intolerance to opiates, renal or hepatic insufficiency, a body weight of less than 50kg, hypoxia (defined as pulse oxygen saturation below 94%) and hemodynamic instability defined as systolic blood pressure below 90mmHg and/or heart rate below 60 bpm will not be included in the study. Patients presenting with associated lesions or pain in the head, face or abdomen will also be excluded from the study. Recruitment methods. All subjects presenting to the ED during the study period for a traumatic injury of the limbs, thorax or spine requiring opioid treatment because of a VAS of 7 or above will be screened for eligibility. Data collection and reporting. Data will be collected mainly through a predetermined data collection sheet at the bedside. In some cases the patient hospital and record might be consulted for missing data. Expected outcomes. It is the sponsor’s expectation that treatment with intranasal sufentanil will be associated with a faster and larger reduction in the VAS compared to treatment with intravenous and oral opioids fifteen to twenty minutes after randomization. Moreover, the sponsor expectation is that treatment with intranasal sufentanil will be associated with larger reduction in VAS compared to treatment with intravenous and oral opioids one hour after randomization. Finally the sponsor expect that intranasal sufentanil will be associated with fewer intravenous catheter placement. Adverse reactions. Intranasal sufentanil as well as intravenous and oral opioids might be associated with numerous side effects. Nausea, vomiting, diaphoresis, dizziness, bradypnea, low oxygen saturation, bradycardia, hypotension are among the most frequently observed side effects that will be monitored during the study period and observation. We expect a similar proportion of side effects in the two groups.