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

NCT ID: NCT03420911

Last Updated: 2018-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-12-31

Brief Summary

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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

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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".

Conditions

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Pain, Acute Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants were randomly assigned into two groups with a 1:1 allocation following simple randomization procedures by a program generating an online random number
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Sequenced study medications were prepared by a nurse, and another nurse administered the medications.

Study Groups

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dexketoprofen trometamol group

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

Group Type ACTIVE_COMPARATOR

dexketoprofen trometamol

Intervention Type DRUG

dexketoprofen trometamol plus midazolam group

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.

Group Type ACTIVE_COMPARATOR

dexketoprofen trometamol

Intervention Type DRUG

Midazolam

Intervention Type DRUG

Interventions

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dexketoprofen trometamol

Intervention Type DRUG

Midazolam

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Derince Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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ASIM ENES ÖZBEK

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 10346837 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16816586 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22981626 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20336798 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20889289 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24270933 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12243307 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18298508 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19041612 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/nlmcatalog/100889125

Pain clinical manual / Margo McCaffery, Chris Pasero.

http://www.iasp-pain.org/Taxonomy

IASP Task Force on Taxonomy Part III: Pain Terms, A Current List with Definitions and Notes on Usage. IASP Task Force Taxon.

Other Identifiers

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2013/147

Identifier Type: -

Identifier Source: org_study_id

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