pain-threshold MedDRA version: 6.1 Level: HLT Classification code 10029772
Conditions
Interventions
Trade Name: ketanest
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ketamine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: .375-
Pharmaceutical
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: primiparae age 18-40 ASA I-II no maternal-fetal disease 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: nd
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: estimate modifications on the pain-threshold in labour and the effects of the epidural analgesia and S-Ketamina on the pai-threshold;Secondary Objective: to estimate maternal-fetal effect to estimate the effectiveness on the extension of analgesic action of epidural opioids;Primary end point(s): nd | — |
Countries
Italy
Outcome results
None listed