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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.
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".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexketoprofen trometamol | Drug |
| ||
| Midazolam |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10346837 | Background | 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. | |
| 16816586 | 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. |
| Label | URL |
|---|---|
| Pain clinical manual / Margo McCaffery, Chris Pasero. | View source |
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undecided
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| D004630 | Emergencies |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C118296 | dexketoprofen trometamol |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Participants were randomly assigned into two groups with a 1:1 allocation following simple randomization procedures by a program generating an online random number
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Sequenced study medications were prepared by a nurse, and another nurse administered the medications.
| Drug |
|
| 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 |
| 22981626 | 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. |
| 20336798 | 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. |
| 20889289 | 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. |
| 24270933 | 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. |
| 12243307 | 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. |
| 18298508 | 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. |
| 19041612 | 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. |
| IASP Task Force on Taxonomy Part III: Pain Terms, A Current List with Definitions and Notes on Usage. IASP Task Force Taxon. | View source |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D006571 | Heterocyclic Compounds |