S-Ketamine to reduce pain associated with negative pressure wound therapy dressing change
- Conditions
- adult patients undergoing negative pressure wound therapy dressing changeMedDRA version: 16.1Level: LLTClassification code 10074212Term: Vacuum assisted wound closureSystem Organ Class: 100000004865Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2013-005114-35-FI
- Lead Sponsor
- Helsinki UNiversity Central Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
adult patients undergoing negative pressure wound therapy dressing change
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 23
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
BMI >40, ischemic cardiac disease, increased intracranial pressure, increased intraocular pressure, graviidity, lactation, hypersensitivity or allegy to ketamine, fentanyl or midazolam, severe psychiatric disease, drug addiction, unability to use NRS-pain scale
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to reduce pain and the need of rescue fentanyl during negative pressure wound therapy dressing change associated pain;Secondary Objective: evaluating haemodynamic changes and possible confusion;Primary end point(s): pain during negative pressure wound therapy dressing change, the need of rescue fentanyl (an opiodi) during the procedure);Timepoint(s) of evaluation of this end point: pain at the beginning of the procedure and at 15 minutes, 30 minutes, 45 minutes and 60 minutes, after 3 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): evaluation of hemodynamic changes /heart rate, blood pressure) and oxygen saturation, evaluation of confusion;Timepoint(s) of evaluation of this end point: 15, 30, 45 and 60 minutes for RR, p, Sp02<br>15 and 60 minutes for confusion using RASS-scale (Richmond Agitation Sedation scale)