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Determination of the Effects of Change in Anxiety Level on Pain Perception in Patients Who Present to Emergency Department

Primary Purpose

Pain, Acute, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
dexketoprofen trometamol
Midazolam
Sponsored by
Derince Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute focused on measuring pain, anxiety, emergency department, pain management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patients who presented to the emergency department with acute pain
  • Who accepted to include the study
  • Who were older than 18 years old

Exclusion Criteria:

  • Patients who refused to participate to the study
  • History of allergy to any of the study drugs
  • Pregnancy
  • Younger than 18 years old
  • Chronic pain
  • Antidepressant or anxiolytic drug use
  • Advanced kidney or liver failure
  • Use of analgesics within 6 hours before presentation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    dexketoprofen trometamol group

    dexketoprofen trometamol plus midazolam group

    Arm Description

    Received the study drugs in 100 mL of normal saline within 5 minutes. The dexketoprofen trometamol dose was 50 mg

    Received the study drugs in 100 mL of normal saline within 5 minutes. The dexketoprofen trometamol dose was 50 mg and the midazolam dose was 1 mg.

    Outcomes

    Primary Outcome Measures

    the change in pain levels
    the change in pain levels between groups on the 100mm visual analogue scale at 0-30th minutes
    the change in anxiety levels
    the change in anxiety levels between groups on the 100mm visual analogue scale at 0-30th minutes

    Secondary Outcome Measures

    the need for rescue treatment
    the need for rescue treatment at 60th minute and at 120 th minute
    the rate of the request for the same treatment
    the rate of the request for the same treatment again on the Likert scale
    the comparison of the pain and anxiety change on the visual analogue scale
    the comparison of the pain and anxiety change on the visual analogue scale in patients who have a greater anxiety score.

    Full Information

    First Posted
    January 16, 2018
    Last Updated
    February 1, 2018
    Sponsor
    Derince Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03420911
    Brief Title
    Determination of the Effects of Change in Anxiety Level on Pain Perception in Patients Who Present to Emergency Department
    Official Title
    Determination of the Effects of Change in Anxiety Level on Pain Perception in Patients Who Present to Emergency Department Due to Acute Pain: a Double Blind, Randomized, Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2013 (Actual)
    Primary Completion Date
    December 2013 (Actual)
    Study Completion Date
    December 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Derince Training and Research Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of this study is to determine the level of pain and anxiety in patients who present to the emergency department with acute pain, and to investigate the effect of the standard analgesic treatment and an additional anxiolytic treatment on pain and anxiety.
    Detailed Description
    After triage, each acute pain patient who qualified for the study was asked for consent. Written informed consent was obtained from all patients who were eligible for the study. After obtaining written informed consent, demographic and clinical data were collected and recorded by the attending physician. Our study consisted of two parallel groups. Participants were randomly assigned into two groups with a 1:1 allocation following simple randomization procedures by a program generating an online random number. The control group was given only the analgesic drug dexketoprofen trometamol and the study group was given analgesic plus anxiolytic, the same dose of dexketoprofen trometamol plus midazolam . Both groups received the study drugs in 100 mL of normal saline within 5 minutes. The dexketoprofen trometamol dose was 50 mg, and the midazolam dose was 1 mg. The study was double-blind. Sequenced study medications were prepared by a nurse, and another nurse administered the medications. In patients with an insufficient improvement of pain after 60 minutes, fentanyl 1 mcg/kg ı.v. was administered as a rescue medication. Pain and anxiety in patients was measured at 0, 30, 60 and 120 minutes using the standard 100 mm horizontal visual analogue scale (VAS). The patient's general anxiety states were measured with the Turkish adopted version of the Hospital Anxiety and Depression Scale (HADS). Patients who have greater than 10 points are assumed anxious (9). The HADS and VAS scores were measured and recorded to the database by the researcher. At the time of discharge, patient satisfaction with treatment was evaluated by asking two questions with the 5-step Likert scale. The questions were, "I am satisfied with the applied treatment", and "I would like the same treatment applied again". Patient answers were, "1-I strongly disagree", "2-I disagree", "3-I am not sure", "4-I agree", and "5-I strongly agree".

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Acute, Anxiety
    Keywords
    pain, anxiety, emergency department, pain management

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants were randomly assigned into two groups with a 1:1 allocation following simple randomization procedures by a program generating an online random number
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Masking Description
    Sequenced study medications were prepared by a nurse, and another nurse administered the medications.
    Allocation
    Randomized
    Enrollment
    180 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    dexketoprofen trometamol group
    Arm Type
    Active Comparator
    Arm Description
    Received the study drugs in 100 mL of normal saline within 5 minutes. The dexketoprofen trometamol dose was 50 mg
    Arm Title
    dexketoprofen trometamol plus midazolam group
    Arm Type
    Active Comparator
    Arm Description
    Received the study drugs in 100 mL of normal saline within 5 minutes. The dexketoprofen trometamol dose was 50 mg and the midazolam dose was 1 mg.
    Intervention Type
    Drug
    Intervention Name(s)
    dexketoprofen trometamol
    Intervention Type
    Drug
    Intervention Name(s)
    Midazolam
    Primary Outcome Measure Information:
    Title
    the change in pain levels
    Description
    the change in pain levels between groups on the 100mm visual analogue scale at 0-30th minutes
    Time Frame
    30 minutes
    Title
    the change in anxiety levels
    Description
    the change in anxiety levels between groups on the 100mm visual analogue scale at 0-30th minutes
    Time Frame
    30 minutes
    Secondary Outcome Measure Information:
    Title
    the need for rescue treatment
    Description
    the need for rescue treatment at 60th minute and at 120 th minute
    Time Frame
    120 minutes
    Title
    the rate of the request for the same treatment
    Description
    the rate of the request for the same treatment again on the Likert scale
    Time Frame
    120 minutes
    Title
    the comparison of the pain and anxiety change on the visual analogue scale
    Description
    the comparison of the pain and anxiety change on the visual analogue scale in patients who have a greater anxiety score.
    Time Frame
    120 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The patients who presented to the emergency department with acute pain Who accepted to include the study Who were older than 18 years old Exclusion Criteria: Patients who refused to participate to the study History of allergy to any of the study drugs Pregnancy Younger than 18 years old Chronic pain Antidepressant or anxiolytic drug use Advanced kidney or liver failure Use of analgesics within 6 hours before presentation

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    undecided
    Citations:
    PubMed Identifier
    10346837
    Citation
    Tanabe P, Buschmann M. A prospective study of ED pain management practices and the patient's perspective. J Emerg Nurs. 1999 Jun;25(3):171-7. doi: 10.1016/s0099-1767(99)70200-x.
    Results Reference
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    PubMed Identifier
    16816586
    Citation
    Karwowski-Soulie F, Lessenot-Tcherny S, Lamarche-Vadel A, Bineau S, Ginsburg C, Meyniard O, Mendoza B, Fodella P, Vidal-Trecan G, Brunet F. Pain in an emergency department: an audit. Eur J Emerg Med. 2006 Aug;13(4):218-24. doi: 10.1097/01.mej.0000217975.31342.13.
    Results Reference
    background
    PubMed Identifier
    22981626
    Citation
    Craven P, Cinar O, Madsen T. Patient anxiety may influence the efficacy of ED pain management. Am J Emerg Med. 2013 Feb;31(2):313-8. doi: 10.1016/j.ajem.2012.08.009. Epub 2012 Sep 13.
    Results Reference
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    PubMed Identifier
    20336798
    Citation
    Ocanez KL, McHugh RK, Otto MW. A meta-analytic review of the association between anxiety sensitivity and pain. Depress Anxiety. 2010 Aug;27(8):760-7. doi: 10.1002/da.20681.
    Results Reference
    background
    PubMed Identifier
    20889289
    Citation
    Ethier C, Burry L, Martinez-Motta C, Tirgari S, Jiang D, McDonald E, Granton J, Cook D, Mehta S; Canadian Critical Care Trials Group. Recall of intensive care unit stay in patients managed with a sedation protocol or a sedation protocol with daily sedative interruption: a pilot study. J Crit Care. 2011 Apr;26(2):127-32. doi: 10.1016/j.jcrc.2010.08.003.
    Results Reference
    background
    PubMed Identifier
    24270933
    Citation
    Behrbalk E, Halpern P, Boszczyk BM, Parks RM, Chechik O, Rosen N, Shapira A, Merose O, Uri O. Anxiolytic medication as an adjunct to morphine analgesia for acute low back pain management in the emergency department: a prospective randomized trial. Spine (Phila Pa 1976). 2014 Jan 1;39(1):17-22. doi: 10.1097/BRS.0000000000000038.
    Results Reference
    background
    PubMed Identifier
    12243307
    Citation
    Bonett DG, Price RM. Statistical inference for a linear function of medians: confidence intervals, hypothesis testing, and sample size requirements. Psychol Methods. 2002 Sep;7(3):370-83. doi: 10.1037/1082-989x.7.3.370.
    Results Reference
    background
    PubMed Identifier
    18298508
    Citation
    Mok LC, Lee IF. Anxiety, depression and pain intensity in patients with low back pain who are admitted to acute care hospitals. J Clin Nurs. 2008 Jun;17(11):1471-80. doi: 10.1111/j.1365-2702.2007.02037.x. Epub 2008 Feb 19.
    Results Reference
    background
    PubMed Identifier
    19041612
    Citation
    Oktay C, Eken C, Ozbek K, Ankun G, Eray O, Avci AB. Pain perception of patients predisposed to anxiety and depressive disorders in emergency department. Pain Manag Nurs. 2008 Dec;9(4):150-3, 153.e1-3. doi: 10.1016/j.pmn.2008.06.002.
    Results Reference
    background
    Links:
    URL
    http://www.iasp-pain.org/Taxonomy
    Description
    IASP Task Force on Taxonomy Part III: Pain Terms, A Current List with Definitions and Notes on Usage. IASP Task Force Taxon.

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    Determination of the Effects of Change in Anxiety Level on Pain Perception in Patients Who Present to Emergency Department

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