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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01950000
Recruitment Status : Completed
First Posted : September 25, 2013
Last Update Posted : September 30, 2013
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief 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.


Condition or disease Intervention/treatment Phase
Critical Illness Pain Drug: Fentanyl Other: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : March 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950000


Locations
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Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT01950000    
Other Study ID Numbers: IRS-FEN-2010-01
First Posted: September 25, 2013    Key Record Dates
Last Update Posted: September 30, 2013
Last Verified: September 2013
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Pain. Analgesia. Prevention
Additional relevant MeSH terms:
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Critical Illness
Pain, Procedural
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics