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

Study Overview
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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.

Official Title
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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

Conditions
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Pain, Acute, Anxiety

Intervention / Treatment
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* Drug: dexketoprofen trometamol
* Drug: Midazolam


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dexketoprofen trometamol group<br>Received the study drugs in 100 mL of normal saline within 5 minutes. The dexketoprofen trometamol dose was 50 mg | Drug: dexketoprofen trometamol<br> <br> |
| Active Comparator: dexketoprofen trometamol plus midazolam group<br>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<br> <br> Drug: Midazolam<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, anxiety, emergency department, pain management