An interventional study of dexketoprofen trometamol and Midazolam in Pain, Acute and Anxiety, sponsored by Derince Training and Research Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-05.
Sponsored by Derince Training and Research Hospital · Not applicable, Interventional, and Treatment
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".
1,073 studies on the registry are indexed under Acute Pain; 166 are open to participants now.
This study's enrollment of 180 is above the median of 86 across 902 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →Derince Training and Research Hospital is the lead sponsor of 39 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Received the study drugs in 100 mL of normal saline within 5 minutes. The dexketoprofen trometamol dose was 50 mg
Drug: dexketoprofen trometamol
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
the change in pain levels
the change in pain levels between groups on the 100mm visual analogue scale at 0-30th minutes
Time frame: 30 minutes
the change in anxiety levels
the change in anxiety levels between groups on the 100mm visual analogue scale at 0-30th minutes
Time frame: 30 minutes
the need for rescue treatment
the need for rescue treatment at 60th minute and at 120 th minute
Time frame: 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
Time frame: 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.
Time frame: 120 minutes
No study locations are listed for this record.
Plan to share: Undecided — undecided
Ran from Jun 2013 to primary completion in Dec 2013, 6 months.
Of 424 non-industry interventional studies with no phase under Acute Pain, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 23. This study's 6 months is below that.
Counting every sponsor, half of 430 studies reached it within 11 months; a quarter within 5 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Midazolam
Derince Training and Research Hospital