Pain, Acute, Anxiety
Conditions
Keywords
pain, anxiety, emergency department, pain management
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.
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.
Interventions
DRUGMidazolam
Sponsors
Derince Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Sequenced study medications were prepared by a nurse, and another nurse administered the medications.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the change in anxiety levels | 30 minutes | the change in anxiety levels between groups on the 100mm visual analogue scale at 0-30th minutes |
| the change in pain levels | 30 minutes | the change in pain levels between groups on the 100mm visual analogue scale at 0-30th minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the need for rescue treatment | 120 minutes | the need for rescue treatment at 60th minute and at 120 th minute |
| the rate of the request for the same treatment | 120 minutes | the rate of the request for the same treatment again on the Likert scale |
| the comparison of the pain and anxiety change on the visual analogue scale | 120 minutes | the comparison of the pain and anxiety change on the visual analogue scale in patients who have a greater anxiety score. |
Outcome results
None listed