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Pain, AcuteNCT03420911

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

A study testing dexketoprofen trometamol and Midazolam in people with Pain, Acute and Anxiety, run by Derince Training and Research Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Acute, Anxiety
What is being tested?
dexketoprofen trometamol and Midazolam
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
No sites listed yet
Study dates
Jun 2013to Dec 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patients who presented to the emergency department with acute pain
  • Who accepted to include the study
  • Who were older than 18 years old

Who cannot join

  • 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

About this study

Official title: 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.

Read the 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".

Conditions
Pain, Acute, Anxiety
Being tested
dexketoprofen trometamol, Midazolam
Keywords
pain, anxiety, emergency department, pain management
Medical subject headings
Acute Pain, Anxiety Disorders, Pain, Emergencies, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03420911
Study groupRoleWhat they receive
dexketoprofen trometamol groupActive comparatorReceived the study drugs in 100 mL of normal saline within 5 minutes. The dexketoprofen trometamol dose was 50 mg
Receives: Drug: dexketoprofen trometamol
dexketoprofen trometamol plus midazolam groupActive comparatorReceived 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.
Receives: Drug: dexketoprofen trometamol; Drug: Midazolam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the change in pain levels

    the change in pain levels between groups on the 100mm visual analogue scale at 0-30th minutes

    Measured: 30 minutes

  2. the change in anxiety levels

    the change in anxiety levels between groups on the 100mm visual analogue scale at 0-30th minutes

    Measured: 30 minutes

Secondary outcomes (3)

  1. the need for rescue treatment

    the need for rescue treatment at 60th minute and at 120 th minute

    Measured: 120 minutes

  2. the rate of the request for the same treatment

    the rate of the request for the same treatment again on the Likert scale

    Measured: 120 minutes

  3. 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.

    Measured: 120 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2018
  2. Study startJun 2013
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03420911
Sponsor's protocol ID
2013/147
Status last verified
Feb 2018
First submitted
16 Jan 2018
Last updated
5 Feb 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: undecided

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.

    PubMed 10346837

  • 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.

    PubMed 16816586

  • 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.

    PubMed 22981626

  • 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.

    PubMed 20336798

  • 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.

    PubMed 20889289

  • 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.

    PubMed 24270933

  • 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.

    PubMed 12243307

  • 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.

    PubMed 18298508

  • 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.

    PubMed 19041612

Questions about this trial

What is this clinical trial studying?

A study testing dexketoprofen trometamol and Midazolam in people with Pain, Acute and Anxiety, run by Derince Training and Research Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the change in pain levels (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03420911, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.

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