Treatment of Procedural Pain Associated With Turning in Patients With Mechanical Ventilation
Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 4
Details
Lead Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau