POST-OPERATIVE PAIN CONTROL OF PEDIATRIC PATIENTS UNDERWENT ORTHOPEDIC SURGERY MedDRA version: 9.1 Level: SOC Classification code 10028395
Conditions
Interventions
Trade Name: NAROPINA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ropivacaine
Concentration unit: mg/m3 milligram(s)/cubic meter
Concentration type: equal
Concentration number: 2-
Sponsors
AZIENDA OSPEDALIERA MAGGIORE DELLA CARITA` DI NOVARA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - child aged between 6 and 13 years - ASA 1-2 - interventions for correction of splayfoot (sec. Castmann) and genu valgum or varum deformities (eight-plate) 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: - age less than 6 and more than 13 years - ASA 3-4 - lack of patient or his/her parents accordance - positive history for asthma or other cardio-respiratory disease - allergy of local anesthetics or propofol - central nervous system or psychiatric disorders - coagulopathy or bleeding diathesis - undergoing infection with systemic manifestation - failure of loco-regional nerve block
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: are optimization of analgesic procedures and improve of pain relief, during and after orthopedic surgical interventions of short duration and one day admission in pediatric patients, this interventions implicates bone manipulations, that may provoke increased pain, discomfort and anxiety in this young patients.;Secondary Objective: - to monitor the use of analgesic agents like NSAID (non steroidal anti-inflammatory drugs) and opioids; nevertheless, the use of these agents are not approved for pediatric patients, and their effectiveness are highly influenced by administration issues - to follow up complication related to anesthesia as allergic reaction, prurit, nausea, vomiting, long lusting sedative effects, disorientation, urinary retention, - risk and benefit analysis of the use of central epidural nerve block in order to improve the quality of postoperative analgesia and patients comfort;Primary end point(s): to ameliorate the postoperative pain relief after orthopedic surgery in pediatric patients and to reduce the use of intravenous analgesic agents, taking account the risk and benefit analysis of the procedure as well | — |
Countries
Italy
Outcome results
None listed