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

NCT01950000 | Completed Phase 4 DMC

• 1 other identifier: IRS-FEN-2010-01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Pain

Keywords

Pain. Analgesia. Prevention

Outcome Measures

Primary Outcomes (1)

• Change in the incidence of pain at the beginning and end of rotation

  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 Outcomes (1)

• Area under the curve (AUC) of incidence of pain (BPS) during mobilizations with spin

  Since the end of the turn until 30 minutes after

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo Treatment: A sterile sodium chloride injection 0.9% 10 ml

Other: Placebo

Fentanest

EXPERIMENTAL

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

Interventions

Fentanyl DRUG

Fentanest

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all the following criteria:
• Patients that will come with a minimum 24-hour schedule of mechanical ventilation (MV)
• Patients men and women\> 18 years and \<85 years
• Patients speak and / or understand the Castilian / Catalan
• Patients with hemodynamic and respiratory stability enough, that allows mobilization procedure turn.
• Patients who have a carer / guardian giving consent to participate in the study

You may not qualify if:

• The subjects presenting one or more of the following criteria are NOT eligible to participate in this study:
• Patients with known hypersensitivity to fentanyl and muscle relaxants
• Patients who are receiving a neuromuscular blocking Neurocritical
• Patients serious (TCE and / or other severe neurological injury (Glasgow \<8), increased intracranial pressure, peripheral neuropathy, quadriplegia)
• Patients with brain death or vegetative state
• Patients who have received some extra supplement opioids (morphine, Fentanest) bolus within 4 hours prior to the study.
• Collaboration in the 30 days prior to any study either experimental drugs or devices.
• 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.
• Patients undergoing treatment with Monoamine Oxidase Inhibitors
• Women who are pregnant

Sponsors & Collaborators

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

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Related Publications (2)

• Robleda G, Roche-Campo F, Sendra MA, Navarro M, Castillo A, Rodriguez-Arias A, Juanes-Borrego E, Gich I, Urrutia G, Nicolas-Arfelis JM, Puntillo K, Mancebo J, Banos JE. Fentanyl as pre-emptive treatment of pain associated with turning mechanically ventilated patients: a randomized controlled feasibility study. Intensive Care Med. 2016 Feb;42(2):183-91. doi: 10.1007/s00134-015-4112-7. Epub 2015 Nov 10.

  PMID: 26556618 DERIVED

• Robleda G, Roche-Campo F, Urrutia G, Navarro M, Sendra MA, Castillo A, Rodriguez-Arias A, Juanes-Borrejo E, Gich I, Mancebo J, Banos JE. A randomized controlled trial of fentanyl in the pre-emptive treatment of pain associated with turning in patients under mechanical ventilation: research protocol. J Adv Nurs. 2015 Feb;71(2):441-50. doi: 10.1111/jan.12513. Epub 2014 Aug 28.

  PMID: 25168967 DERIVED

MeSH Terms

Conditions

Critical Illness; Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ferran Roche-Campo, MD PhD

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

  STUDY DIRECTOR

• Gemma Robleda, Rn PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2013
• First Posted: September 25, 2013
• Study Start: March 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: September 30, 2013

Record last verified: 2013-09

Locations

ES (1)