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

NCT03420911 | Completed DMC

• 1 other identifier: 2013/147
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain, Acute; Anxiety

Keywords

pain; anxiety; emergency department; pain management

Outcome Measures

Primary Outcomes (2)

• the change in pain levels

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

  30 minutes

• the change in anxiety levels

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

  30 minutes

Secondary Outcomes (3)

• the need for rescue treatment

  120 minutes

• the rate of the request for the same treatment

  120 minutes

• the comparison of the pain and anxiety change on the visual analogue scale

  120 minutes

Study Arms (2)

dexketoprofen trometamol group

ACTIVE COMPARATOR

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

Drug: dexketoprofen trometamol

dexketoprofen trometamol plus midazolam group

ACTIVE COMPARATOR

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.

Drug: dexketoprofen trometamol; Drug: Midazolam

Interventions

dexketoprofen trometamol DRUG

dexketoprofen trometamol group; dexketoprofen trometamol plus midazolam group

Midazolam DRUG

dexketoprofen trometamol plus midazolam group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Derince Training and Research Hospital: lead

Related Publications (9)

• 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.

  PMID: 10346837 BACKGROUND

• 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.

  PMID: 16816586 BACKGROUND

• 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.

  PMID: 22981626 BACKGROUND

• 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.

  PMID: 20336798 BACKGROUND

• 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.

  PMID: 20889289 BACKGROUND

• 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.

  PMID: 24270933 BACKGROUND

• 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.

  PMID: 12243307 BACKGROUND

• 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.

  PMID: 18298508 BACKGROUND

• 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.

  PMID: 19041612 BACKGROUND

Related Links

• Pain clinical manual / Margo McCaffery, Chris Pasero.
• IASP Task Force on Taxonomy Part III: Pain Terms, A Current List with Definitions and Notes on Usage. IASP Task Force Taxon.

MeSH Terms

Conditions

Acute Pain; Anxiety Disorders; Pain; Emergencies; Agnosia

Interventions

dexketoprofen trometamol; Midazolam

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Disease Attributes; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sequenced study medications were prepared by a nurse, and another nurse administered the medications.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: February 5, 2018
• Study Start: June 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 5, 2018

Record last verified: 2018-02