TARGET-CONTROLLED INFUSION (TCI) WITH PROPOFOL AND REMIFENTANIL AS ANALGO-SEDATION IN WOUND CARE IN PEOPLE WITH BURNS

Phase 1

• Conditions: MedDRA version: 14.1Level: LLTClassification code 10028175Term: Multiple burnsSystem Organ Class: 100000004863; Burn patients who need analgo-sedation during wound care.; Therapeutic area: Health Care [N] - Health Care Facilities, Manpower, and Services [N02]

• Registration Number: EUCTR2013-000476-14-SE
• Lead Sponsor: ANDSTINGET I ÖSTERGÖTLAND

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-19
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

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

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.

Study & Design

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