Treatment of Procedural Pain Associated With Turning in Patients With Mechanical Ventilation

September 27, 2013 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Efficacy and Safety of Opioid Analgesics as a Preventive Treatment of Procedural Pain Associated With Turning Among Critically Ill Patients Under Mechanical Ventilation. A Controlled Clinical Trial Comparing Placebo and Fentanyl

Background: Few studies have addressed the situation of procedural pain and the use of preemptive analgesia for turning in patients under mechanical ventilation.

Aim: Evaluation effect of preemptive fentanyl on the incidence of pain during turning maneuvers in critically ill patients under mechanical ventilation.

Design: Single-center clinical trial, national, randomized, double-blind, with a parallel group, and two arms of treatment: saline placebo and fentanyl.

Primary Endpoint: Incidence of pain during the turning procedures that are carried out by nurses measured by means of the Behavioral Pain Scale (BPS).

Study Population: Critically ill patients, age > 18 years, admitted to ICU and expected to require mechanical ventilation for at least 24 h.

Sample Size: 80 patients divided into the two groups (40 patients each). Statistical Analysis: A preliminary descriptive analysis will be carried. Later, results of primary end point will be comparing after the eventual corrections of corresponding variables using a multivariable approach. The AUC variable will be analyzed by a t-test for unpaired data. A second analysis using a multivariate approach will be carried out for those factors considered as clinically relevant in relation to pain and therefore a logistic regression will be used.

Ethical Considerations: The study will be strictly conducted following the Declaration of Helsinki and the protocol and Standard Operating Procedures (SOPs) to ensure compliance with the Good Clinical Practice (GCP) standards. It is the responsibility of the researcher to obtain the valid informed consent from the guardian / legal representative, as the patient's condition will not allow to consent. Before obtaining the consent the investigator will explain to each guardian / legal representative the nature of the study, its purpose, the procedures, the estimated duration, the potential risks and benefits associated with the participation, as well as any inconvenience that this may involve.

Duration of Treatment: The treatment has a maximum duration of 60 min for each patient. The follow-up includes visits and has duration of 6 consecutive days.

Safety Assessment: Potential side effects of treatments will be recorded. Frequent adverse effects of fentanyl administration include respiratory depression, apnea, muscle rigidity, bradycardia and transient hypotension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects must meet all the following criteria:

  1. Patients that will come with a minimum 24-hour schedule of mechanical ventilation (MV)
  2. Patients men and women> 18 years and <85 years
  3. Patients speak and / or understand the Castilian / Catalan
  4. Patients with hemodynamic and respiratory stability enough, that allows mobilization procedure turn.
  5. Patients who have a carer / guardian giving consent to participate in the study

Exclusion Criteria:

The subjects presenting one or more of the following criteria are NOT eligible to participate in this study:

  1. Patients with known hypersensitivity to fentanyl and muscle relaxants
  2. Patients who are receiving a neuromuscular blocking Neurocritical
  3. Patients serious (TCE and / or other severe neurological injury (Glasgow <8), increased intracranial pressure, peripheral neuropathy, quadriplegia)
  4. Patients with brain death or vegetative state
  5. Patients who have received some extra supplement opioids (morphine, Fentanest) bolus within 4 hours prior to the study.
  6. Collaboration in the 30 days prior to any study either experimental drugs or devices.
  7. Patients that potentially present alterations in the ability to understand when they are aware to understand the purpose of the study and to give informed consent in writing.
  8. Patients undergoing treatment with Monoamine Oxidase Inhibitors
  9. Women who are pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo Treatment: A sterile sodium chloride injection 0.9% 10 ml
Other: Placebo
Experimental: Fentanest

For this study Fentanest doses were adjusted based on published guidelines from the values recommended media to a whole number and differentiating two groups of patients (multiple trauma / surgical or medical) The maximum dose is 100 mcg Fentanest. The multiple trauma patients / surgical 1.5 mcg / kg and in medical patients 1.0 mcg / kg were given a single bolus Fentanest / Placebo by type of patient (surgical / multiple trauma or physician) 5 'before turning mobilization with personal hygiene.

The bolus is given slowly (30'') intravenously, to be preferred by a peripheral without vasoactive drugs (only with fluid therapy).

Pharmaceutical form:

Sterile solution for injection. Each mL of injectable solution contains the equivalent of 0.05 mg of Fentanest; Excipients: sodium chloride and water for injection.
Drug: Fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the incidence of pain at the beginning and end of rotation
Time Frame: Expected average of 5 minutes
Participants will be evaluated at the beginning and the end of rotation, an expected average of 5 minutes. The evaluation of the change in the incidence of pain will be done calculating the mean between the beginning and the end of rotation.
Expected average of 5 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the curve (AUC) of incidence of pain (BPS) during mobilizations with spin
Time Frame: Since the end of the turn until 30 minutes after
Since the end of the turn until 30 minutes after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Investigators

  • Study Director: Ferran Roche-Campo, MD PhD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  • Principal Investigator: Gemma Robleda, Rn PhD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

September 6, 2013

First Submitted That Met QC Criteria

September 20, 2013

First Posted (Estimate)

September 25, 2013

Study Record Updates

Last Update Posted (Estimate)

September 30, 2013

Last Update Submitted That Met QC Criteria

September 27, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRS-FEN-2010-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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