Ensayo clínico controlado y aleatorizado para evaluar el efecto de los gabapentinoides sobre el dolor agudo postoperatorio en pacientes quemados
- Conditions
- Postoperative pain in burned patients with a burn excision area between 2 and 12 % of total body surface area.
- Registration Number
- EUCTR2007-006182-32-ES
- Lead Sponsor
- Anaesthesiology Department. Universitary Hospital Vall d'Hebron, Barcelona.
- 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
Both sexes
Age between 18 and 70 years old
Admision to the Burn Unit of Hospital Universitari Vall d'Hebron, Barcelona, for surgical treatment
Burn excision between 2 and 12 % of body surfece area under general anaesthesia
Estimated length of stay longer than three days
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Inability to operate a PCA device
Neurological deficits
Psychiatric disorders
Opioid abuse
Pregnancy
Use of local anaesthetics
Daily NSAID intake
Renal failure
Allegy to the study medication
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Efficacy of gabapentin and pregabalin on opioid consumption during the 24 h after surgery in burned patients with a burn excision area between 2 and 12 % of total body surface area.;Secondary Objective: VAS pain evaluation in the immediate postoperative period (24 hours)<br>Comparison of gabapentinoids effect to dexketoprofen effect on postoperative analgesia in burned patients<br>Side effects evaluation<br>;Primary end point(s): Opioid consumption during the first 24 hours following surgery
- Secondary Outcome Measures
Name Time Method