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
About this trial
This is an interventional treatment trial for Pain, Acute focused on measuring pain, anxiety, emergency department, pain management
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
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
NCT ID
NCT03420911
First Posted
January 16, 2018
Last Updated
February 1, 2018
Sponsor
Derince Training and Research Hospital
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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Citation
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Results Reference
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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
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Results Reference
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PubMed Identifier
20889289
Citation
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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
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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
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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
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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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