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Clinical Trials/EUCTR2013-000476-14-SE
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.

Registry
who.int
Start Date
March 19, 2013
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
ANDSTINGET I ÖSTERGÖTLAND

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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