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Randomized, controlled, trial, phase III, pregabalin vs placebo on postoperative morphine request after pectus escavatum surgery in children - Pregabalin Study

Randomized, controlled, trial, phase III, pregabalin vs placebo on postoperative morphine request after pectus escavatum surgery in children - Pregabalin Study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-011384-36-IT
Enrollment
Unknown
Registered
2009-07-03
Start date
2009-09-22
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Acute pain management

Interventions

Trade Name: LYRICA Pharmaceutical Form: Capsule, hard INN or Proposed INN: PREGABALIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of th

Sponsors

ISTITUTO GIANNINA GASLINI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Children aged more than 11 ASA 1 and 2 Pectus escavatum surgery Written informed consent Are the trial subjects under 18? yes 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 3, 4 and 5 Hepatic and renal failure Drugs and alchool abuse Chronic pain

Design outcomes

Primary

MeasureTime frame
Main Objective: Morphine request reduction after pectus escavatum surgery in children;Secondary Objective: Tolerance and incidence of adverse events after pregabalin administration, level of pain, side effects opioids related.;Primary end point(s): Morphine sparing effects—

Countries

Italy

Outcome results

None listed

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