Pain management after scolios surgery on children/adolescents with idiopathic scoliosis MedDRA version: 9.1 Level: LLT Classification code 10036236 Term: Postoperative pain relief MedDRA version: 9.1 Level: LLT Classification code 10039727 Term: Scoliosis surgery
Conditions
Interventions
Trade Name: Ketanest-S
Product Name: Ketanest S
Pharmaceutical Form: Intravenous infusion
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous d
Sponsors
Umeå University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Consecutive children/adolscents scheduled for correctional surgery for idiopathic scoliosis. 12-18 years of age. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any known hypersensitivty to any drug included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare two different modes of pain management concerning subjective pain measurment;Secondary Objective: Nausea, gastrointestinal function, a mount of and time to first rescue analgesia, global rating of patient satsifaction,pruritus, postopertive psychological impact. To improve saftey in pain management since epidural analgesia could involve serious side effects as infection and neurologic damage.;Primary end point(s): Pain at hospital and at home, intensity and duration, measured by VAS (0-100 mm) | — |
Countries
Sweden
Outcome results
None listed