Comparison of Efficacy and Safety of the Postoperative Analgesia Methods

• Register: ClinicalTrials.gov
• Last refreshed on: 24 October 2016
• Main ID: NCT02929147
• Date of registration: 06/10/2016
• Prospective Registration: Yes
• Primary sponsor: Istanbul University
• Public title: Comparison of Efficacy and Safety of the Postoperative Analgesia Methods
• Scientific title: Comparison of Efficacy and Safety of the Postoperative Analgesia Methods for Supratentorial Craniotomy by Integrated Pulmonary Index (IPI)
• Date of first enrolment: November 2016
• Target sample size: 90
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT02929147
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Turkey

Contacts

• Name: Ozlem Korkmaz Dilmen, MD
• Affiliation: Istanbul University Cerrahpasa School of Medicine Istanbul Turkey

• Name: Ozlem Korkmaz Dilmen, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of supratentorial neoplasms

Exclusion Criteria:

- Neurological disorders hindering the communication, aphasia, Glasgow Coma Score (GCS)
less than 15, drug or alcohol addiction, chronic pain, raised intracranial pressure,
allergies to any of the drugs used in this study, hepatic or renal dysfunction,
peptic ulcer disease, dementia.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Supratentorial Neoplasms

Intervention(s)

Drug: Dexketoprofen

Drug: Placebo

Drug: Morphine

Primary Outcome(s)

Integrated Pulmonary Index (IPI) [Time Frame: Change from Beseline IPI values in postoperative first 24 hours.(at 10th minute, 1, 2, 6, 12, and 24 hours post dose)]

Secondary Outcome(s)

Sedation level measured by Ramsay score [Time Frame: Change from Beseline Sedation Level in postoperative first 24 hours(at 10th minute, 1, 2, 6, 12, and 24 hours post dose)]

Cumulative Morphine consumption [Time Frame: Change from Baseline in 1postoperative first 24 hours(at 10th minute, 1, 2, 6, 12, and 24 hours post dose)]

Pain intensity measured by Visual Analog Score [Time Frame: Change from Beseline Pain Intensity in postoperative first 24 hours(at 10th minute, 1, 2, 6, 12, and 24 hours post dose)]

Secondary ID(s)

Istanbul U

Source(s) of Monetary Support

Please refer to primary and secondary sponsors