Skip to content

Ensayo clínico controlado y aleatorizado para evaluar el efecto de los gabapentinoides sobre el dolor agudo postoperatorio en pacientes quemados

Ensayo clínico controlado y aleatorizado para evaluar el efecto de los gabapentinoides sobre el dolor agudo postoperatorio en pacientes quemados

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-006182-32-ES
Enrollment
Unknown
Registered
2010-03-08
Start date
2009-06-03
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain in burned patients with a burn excision area between 2 and 12 % of total body surface area.

Interventions

Trade Name: Neurontín Pharmaceutical Form: Capsule* Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Enteral use (Noncurrent) Trade Name: Lyrica Pharmaceutical For

Sponsors

Anaesthesiology Department. Universitary Hospital Vall d'Hebron, Barcelona.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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) Comparison of gabapentinoids effect to dexketoprofen effect on postoperative analgesia in burned patients Side effects evaluation ;Primary end point(s): Opioid consumption during the first 24 hours following surgery

Countries

Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026