Efficacy and safety of s- Ketamine and Remifentanil for endovenous analgesy in labour pains - ND

• Conditions: endovenous analgesy in labour pains; MedDRA version: 9.1Level: LLTClassification code 10059204Term: Labour pain

• Registration Number: EUCTR2007-003276-19-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-17
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

primipara, age 18-40 years, ASA I-II
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

ASA III-IV, age <18 or >40 years, maternal-fetal diseases

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Analgesic efficacy and safety of s Ketamine in association with remifentanil in endovenous analgesy for labour pains;Secondary Objective: assessment of maternal-fetal adverse events;Primary end point(s): Assessment of efficacy and safety of s Ketamine in association with remifentanil in labour pains