Burn patients who need analgo-sedation during wound care. MedDRA version: 14.1 Level: LLT Classification code 10028175 Term: Multiple burns System Organ Class: 100000004863
Conditions
Interventions
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Remifentanil
CAS Number: 132875-61-7
Other descriptive name: REMIFENTANIL HYDROCHLORIDE
Concentration unit: mg milligram(s)
C
Sponsors
LANDSTINGET I ÖSTERGÖTLAND
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients (= 18 years) with burns regardless degree or extent. The patient should be hospitalized in a swedish burn center. The subject is planned for at least two consecutive occasions with wound care with analgo-sedation. The patient has given their consent to participate in the study. 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Patients who are ventilator treated. Mental or physical inability, unwillingness or language difficulties that causes difficulty to understand the meaning of participation in the study, according to the responsible physician. Wound care where bath is planned. Contraindications to study drug: Known or suspected allergy or hypersensitivity to oxycodone, propofol, remifentanil, morphine, selective 5-HT3 receptor antagonists, fentanyl analog, opioids, pregabalin, paracetamol, naproxen, peanuts or soy. Respiratory depression with or without hypoxia, hypercapnia, severe bronchial asthma patients who have had symptoms of asthma, rhinitis or urticaria after taking aspirin or other anti-inflammatory agents of non-steroidal nature, severe chronic obstructive pulmonary disease and cor pulmonale. Severe heart failure, hypovolemia and hypotension. Increased intracranial pressure or head injury. Myasthenia gravis. Conditions associated with increased bleeding, an ongoing or history of gastrointestinal bleeding or perforation. Cirrhosis of the liver. Kidney disease (glomerular filtration rate <30 ml / min). Paralytic ileus. Third trimester of pregnancy and during lactation. Concomitant use with MAO inhibitors or recent (within two weeks) discontinuation of MAO inhibitors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether Target-Controlled infusion (TCI) with propofol and remifentanil can be used as analgo-sedation on burn patients and if the method can shorten the recovery time after wound care compared with daily routine of continous infusion of propofol with intermittent bolus of fentanyl.;Secondary Objective: To evaluate whether Target-Controlled infusion (TCI) of propofol and remifentanil compared with routine use of continuous infusion of propofol and intermittent bolus doses of fentanyl can shorten the time until mobilisation and nutrition. Measurement of the total energy intake during the day for wound care are implemented as well the number of adverse events and the necessary interventions as well as the total dose administered analgesia and anti-emetics. Finally, the research estimates the perceived pain and experience during wound care. The staff at ward will after the wound care evaluate the wound care conditions.;Primary end point(s): Time to recovery after analgo-sedation.;Timepoint(s) of evaluation of this end point: 0-120 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to mobilization after analgo-sedation. Time to nutrition post analgo-sedation. Energy intake during the day of wound care. During analgo-sedation: Adverse events (AE) interventions Postprocedure: Adverse events (AE) interventions Subjects estimation of subjective pain by using the VAS-scale Total dose of analgesics Total dose antiemetics Subjects subjective experience of the wound care by using the VAS-scale. Staffs experience of wound care conditions.;Timepoint(s) of evaluation of this end point: Day of analgo-sedation (24h) | — |
Countries
Sweden
Contacts
Public ContactUNIVERSITETSSJUKHUSET I LINKÖPING
LANDSTINGET I ÖSTERGÖTLAND
Outcome results
None listed