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

NCT02145975 | Completed Phase 3

• 1 other identifier: UDEAFEN001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Fentanyl is a potent opioid, it is theoretically 100 times more potent that morphine and in severe acute postoperative pain acts faster than its congener (morphine ) for pain relief . In the literature there is no study that corroborates this theoretical assumption and proposes to compare which has fewer adverse effects. This drug produces effects similar to those reported for morphine but less magnitude and has the advantage that during the postoperative period respiratory depression, antitussive effect , gastrointestinal discomfort and physical dependence are manifested in a significantly less degree. Trying to solve the management of postoperative pain relief , our objective is to determine by controlled clinical trial of superiority if in adult patients undergoing surgery , fentanyl reduces faster qualification time of severe pain to mild pain in the postanesthesia care unit compared to morphine.

Conditions

Postoperative Pain

Keywords

Severe postoperative pain; Morphine; Fentanyl; Time to titration of pain; Pain and PACU; Anesthesiology

Outcome Measures

Primary Outcomes (1)

• Time in minutes of titration of fentanyl and morphine in reducing severe postoperative pain to mild pain

  Time in minutes of titration of fentanyl and morphine in reducing postoperative pain severe to mild pain with visual analog scale (≤ 3).

  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 Outcomes (4)

• Stay time of patients in the postanesthetic recovery unit in hours.

  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

  This outcome will be measured in the first hour at the PACU and postoperative 24 hours

• Cumulative dosis

  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

• Saturation of oxygen and arterial pressure

  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.

Study Arms (2)

Fentanyl

EXPERIMENTAL

Procedure: Fentanyl for rescue of acute postoperative pain in the postanesthesia care unit Intervention: The nurse will administer 1 ug per kg during 5 seconds when the patient complain of pain (visual analog scale, VAS, ≥7). Immediately with the onset of drug administration a timer started; every 5 minutes the researcher assess the EVA and the drug will be administered if VAS \> 3, until the patient manifests as a lower pain VAS ≤ 3 (mild). The nurse in charge in the PACU will manage the drug and will take 100 ug of fentanyl which is diluted in 10 mL of normal saline leaving a 10μg per ml concentration, are not labeled and for the physical and chemical characteristics of both drugs (colorless) risks of unblinded is minimized.

Drug: Fentanyl

Morphine

ACTIVE COMPARATOR

Procedure: Morphine for rescue of acute postoperative pain in the postanesthesia care unit Intervention: The nurse will administer 0,1 mg per kg during 5 seconds when the patient complain of pain (visual analog scale, VAS, ≥7). Immediately with the onset of drug administration a timer started; every 5 minutes the researcher assess the EVA and the drug will be administered if VAS \> 3, until the patient manifests as a lower pain VAS ≤ 3 (mild). The nurse in charge in the PACU will manage the drug and will take 10 mg of morphine which is diluted in 10 mL of normal saline leaving a 1 mg per ml concentration, are not labeled and for the physical and chemical characteristics of both drugs (colorless) risks of unblinded is minimized.

Drug: Morphine

Interventions

Fentanyl DRUG

The nurse will administer 1 ug per kg during 5 seconds when the patient complain of pain (visual analog scale, VAS, ≥7). Immediately with the onset of drug administration a timer started; every 5 minutes the researcher assess the EVA and the drug will be administered if VAS \> 3, until the patient manifests as a lower pain VAS ≤ 3 (mild). The nurse in charge in the PACU will manage the drug and will take 100 ug of fentanyl which is diluted in 10 mL of normal saline leaving a 10μg per ml concentration, are not labeled and for the physical and chemical characteristics of both drugs (colorless) risks of unblinded is minimized.

Also known as: Opioids

Fentanyl

Morphine DRUG

The nurse will administer 0,1 mg per kg during 5 seconds when the patient complain of pain (visual analog scale, VAS, ≥7). Immediately with the onset of drug administration a timer started; every 5 minutes the researcher assess the EVA and the drug will be administered if VAS \> 3, until the patient manifests as a lower pain VAS ≤ 3 (mild). The nurse in charge in the PACU will manage the drug and will take 10 mg of morphine which is diluted in 10 mL of normal saline leaving a 1 mg per ml concentration, are not labeled and for the physical and chemical characteristics of both drugs (colorless) risks of unblinded is minimized.

Also known as: Opioids

Morphine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Antioquia: lead

Study Sites (1)

Antioquia University

Medellín, Antioquia, 05001000, Colombia

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Fentanyl; Analgesics, Opioid; Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Adriana Cadavid, MD

  Antioquia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Study Record Dates

• First Submitted: May 18, 2014
• First Posted: May 23, 2014
• Study Start: January 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 23, 2014

Record last verified: 2014-05

Locations

CO (1)