Efficacy of Fentanyl to Reduce the Time of Severe Postoperative Pain Relief Compared to Morphine

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02145975
• Date of registration: 18/05/2014
• Prospective Registration: No
• Primary sponsor: Universidad de Antioquia
• Public title: Efficacy of Fentanyl to Reduce the Time of Severe Postoperative Pain Relief Compared to Morphine
• Scientific title: Efficacy of Fentanyl to Reduce the Time of Severe Postoperative Pain Relief Compared to Morphine: a Randomized Parallel-group, Double-blind Clinical Trial
• Date of first enrolment: January 2014
• Target sample size: 60
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02145975
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Colombia

Contacts

• Name: Adriana Cadavid, MD
• Affiliation: Antioquia University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients physical status I and IV, 18-65 years of age

- Patients scheduled for surgery under general or regional anesthesia and fasting as
defined in the fasting guidelines.

- Patients whose accept and sign the informed consent of study.

Exclusion Criteria:

- Patients with severe respiratory depression given by a monitoring state indicating
hypoxemia (oxyhemoglobin saturation below 90 %).

Patients with immediate postoperative hemodynamic instability given by bradycardia ,
hypotension or hypoperfusion states observed by clinical paleness, active bleeding,
altered sensorium, and altered alertness not explained by effects of anesthetics .

Neurological disorders such as metabolic basis psychiatric disorders, mental retardation,
congenital neurodegenerative conditions, hypoxic or ischemic related to aging that do not
allow adequate evaluation of the analog scale pain assessment.

Patients with a history of tolerance to opioids for chronic use, which is defined to a
period of 2 weeks.

Patients who have undergone epidural analgesia protocols, neuraxial and peripheral nerve
blocks.

Patients with any alteration in neurological status. History of psychiatric disorders.
Patient with known hypersensitivity or allergic reactions to opioids. Women who are
pregnant or suspected to be.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Postoperative Pain

Intervention(s)

Drug: Fentanyl

Drug: Morphine

Primary Outcome(s)

Time in minutes of titration of fentanyl and morphine in reducing severe postoperative pain to mild pain [Time Frame: The outcome will be measured from the patient presents severe pain at the PACU until the time that presents mild pain and he does not need more rescue bolus assessed up to 4 hours]

Secondary Outcome(s)

Cumulative dosis [Time Frame: The outcome will be measured from the patient experiences severe pain at the PACU and is given the first bolus rescue analgesic until is given last bolus rescue analgesic, assessed up to 4 hours]

Stay time of patients in the postanesthetic recovery unit in hours. [Time Frame: The outcomes will be measured from the patient arrives at the PACU until he is discharged or transferred to the hospital room assessed up to 4 hours.]

Satisfaction with the analgesic management [Time Frame: This outcome will be measured in the first hour at the PACU and postoperative 24 hours]

Saturation of oxygen and arterial pressure [Time Frame: The outcomes will be measured from the patient arrives at the PACU until he is discharged or transferred to the hospital room, assessed up to 4 hours.]

Secondary ID(s)

UDEAFEN001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors