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

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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Pain, Acute
• Intervention / Treatment: Drug: Midazolam; Drug: dexketoprofen trometamol

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".

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: dexketoprofen trometamol group; Received the study drugs in 100 mL of normal saline within 5 minutes. The dexketoprofen trometamol dose was 50 mg	Drug: dexketoprofen trometamol
ACTIVE_COMPARATOR: 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.	Drug: Midazolam; Drug: dexketoprofen trometamol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the need for rescue treatment	the need for rescue treatment at 60th minute and at 120 th minute	120 minutes
the rate of the request for the same treatment	the rate of the request for the same treatment again on the Likert scale	120 minutes
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.	120 minutes

Collaborators and Investigators

• Sponsor: Derince Training and Research Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2013
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: January 16, 2018
• First Submitted That Met QC Criteria: February 1, 2018
• First Posted (ACTUAL): February 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2018
• Last Update Submitted That Met QC Criteria: February 1, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: pain; anxiety; emergency department; pain management
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Emergencies; Anxiety Disorders; Acute Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Dexketoprofen trometamol
• Other Study ID Numbers: 2013/147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No