EUCTR2013-000476-14-SE
Active, not recruiting
Phase 1
TARGET-CONTROLLED INFUSION (TCI) WITH PROPOFOL AND REMIFENTANIL AS ANALGO-SEDATION IN WOUND CARE IN PATIENTS WITH BURNS - TCI BRIVA
ANDSTINGET I ÖSTERGÖTLAND0 sites80 target enrollmentMarch 19, 2013
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Burn patients who need analgo-sedation during wound care.
- Sponsor
- ANDSTINGET I ÖSTERGÖTLAND
- Enrollment
- 80
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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