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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-003276-19-IT
Enrollment
Unknown
Registered
2007-12-17
Start date
2007-11-05
Completion date
Unknown
Last updated
2014-02-10

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

Conditions

endovenous analgesy in labour pains MedDRA version: 9.1 Level: LLT Classification code 10059204 Term: Labour pain

Interventions

Trade Name: Ketanest S Pharmaceutical Form: Solution for injection INN or Proposed INN: Ketamine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: .375- Pharmaceutica

Sponsors

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: ASA III-IV, age 40 years, maternal-fetal diseases

Design outcomes

Primary

MeasureTime frame
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—

Countries

Italy

Outcome results

None listed

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