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Clinical Trials/EUCTR2013-003346-16-ES
EUCTR2013-003346-16-ES
Active, not recruiting
Phase 1

Comparative study between continuous perfusion and split doses in the treatment of postoperative pain - Elastomeric pumps versus intravenous split doses in postoperative pain

Hospital Universitari Sagrat cor0 sitesDecember 10, 2015
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ConditionsAnalgesic efficacy in postoperative acute painTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
DrugsMetamizol Normon 2 g / 5 ml Solución inyectable EFGEnantyum 50mg/2ml, solución inyectable o concentrado para solución para perfusiónOndansetrón Fresenius Kabi 2 mg/ml, solución inyectable EFGMORFINA B. BRAUN 10 mg/ml SOLUCION INYECTABLE

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Analgesic efficacy in postoperative acute pain
Sponsor
Hospital Universitari Sagrat cor
Status
Active, not recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 10, 2015
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Hospital Universitari Sagrat cor

Eligibility Criteria

Inclusion Criteria

  • •\- Over 18 years old
  • •\- Patients with analgesic needs superior to 48 hours and an equivalent minimal in\-hospital stay.
  • •\- Patients undergoing:
  • •. Orthopaedic Surgery: hip prosthesis, shoulder pathologies
  • •. General Surgery: eventroplasty, anal fissure and cholectomy
  • •. Gynecologic Surgery: hysterectomy
  • •\- Patients providing informed consent
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • •\- Non elective surgery
  • •\- Different analgesic requirements
  • •\- Patient admission to ICU
  • •\- Allergy or hypersensitivity to any drug used in the study
  • •\- Contraindication for any of the study drugs:
  • •. Medical history of agranulocytosis and aplastic anemia
  • •. Acute intermittent porphyria
  • •. Glucose 6 phosphate dehydrogenase deficiency
  • •. Digestive haemorrhage, esophageal haemorrhage, active peptic ulcer, cranial haemorrhage.
  • •. Respiratory depression

Outcomes

Primary Outcomes

Not specified

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