Sublingual versus intravenous Fentanyl in patients with acute trauma - a randomized, double-blind, double-dummy study to demonstrate non-inferiorityTraumaPACT

Phase 1

• Conditions: Trauma with acute pain; MedDRA version: 20.1Level: LLTClassification code 10066714Term: Acute painSystem Organ Class: 100000004867; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2018-002606-31-DE
• Lead Sponsor: Ruprecht-Karls-University Heidelberg, Medical Faculty represented by Universitätsklinikum Heidelberg and its Commercial

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-30
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 340

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified