Trauma with acute pain MedDRA version: 20.1 Level: LLT Classification code 10066714 Term: Acute pain System Organ Class: 100000004867
Conditions
Interventions
Trade Name: Abstral
Product Name: Abstral
Pharmaceutical Form: Sublingual tablet
INN or Proposed INN: Abstral
Other descriptive name: FENTANYL CITRATE
Concentration unit: µg microgram(s)
Concentration
Sponsors
Ruprecht-Karls-University Heidelberg, Medical Faculty represented by Universitätsklinikum Heidelberg and its Commercial
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age 18-65 years - isolated or combined, non-head trauma - Intravenous access indicated - Glasgow Coma Scale(GCS) score (aggregate of verbal, eye, and motor response scores) of 15 (no disturbance of consciousness) - Stable circulation (blood pressure, pulse) at the discretion of the investigator - Oxygen saturation of at least 95% - Numeric pain rating scale (NRS, 5-10) = 5 - Ability of subject to understand character and individual consequences of the clinical trial - Patient (deferred) consent to treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 340 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pre-treatment with potent opioid-analgesics within 30 days prior to acute trauma - (obvious) pregnancy or lactation - Nasopharyngeal injuries - Obstructive lung disease - Foreseeable indication for endotracheal intubation - Nausea or vomiting expected - History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product - legally incapacitated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •Numeric pain scale (NRS) 15 minutes after first application of treatment ;Secondary Objective: •Time to reduction of one or more points on NRS •Dose to sufficient analgesia •Need for rescue medication after 15 minutes (standard treatment ) •Handling of oral application •Evaluate patients satisfaction with analgesia •Safety (AEs/SAEs) ;Primary end point(s): Numeric pain scale (NRS) 15 minutes after first application of treatment;Timepoint(s) of evaluation of this end point: 15 minutes after first application of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time to reduction of one or more Points on NRS - Dose to sufficient analgesia - Need for rescue medication after 15 minutes (Standard Treatment) - Handling of oral application - Evalute patients satisfaction with analgesia - Safety (AEs/SAEs);Timepoint(s) of evaluation of this end point: during and after treatment | — |
Countries
Germany
Contacts
Public ContactProjectmanagement
Coordination Centre for Clinical Trials (KKS)
Outcome results
None listed