The purpose of this study is to determine the non-inferiority of the efficacy of sublingual given fentanyl versus endovenous given fentanyl for patients in the emergency departement.
Fentanyl endovenous (ev) is an excellent analgesic drug for pain relief in acute traumatic pain. Fentanyl sublingual (Abstral ®) is an excellent analgesic drug in the breakthrough pain relief in oncologic patients. The immediate (10 minutes) effect and the ease of administration of sublingual fentanyl could be a possibility for a fast pain relief in remote areas such as mountain rescue missions. Patients will be recruited according to a randomized list to fentanyl ev or fentanyl sublingual versus placebo oral or placebo ev. Safety issues like control of vital signs will be warranted
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
108
Emergency Room of Bruneck Regional Hospital
Bruneck, Italy
Pain - Relief
Pain - Relief of 2 points on a 11 items pain scale (0 = non pain; 10 = unbearable pain)
Time frame: 1 hour
Practicability / handling of the two dosage forms of fentanyl in emergencies
Practicability / handling
Time frame: 1 hour
Patient comfort
5 items Labert Scale
Time frame: 1 hour
Adverse drug effects
such as pruritus, nausea, dizziness
Time frame: 1 hour
SpO2 (%)
SpO2 \< 92%
Time frame: 1 hour
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