Analgesic Efficacy of Transcutaneous Electrical Nerve Stimulation and Dexketoprofen in Renal Colic
NCT ID: NCT07176572
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
128 participants
INTERVENTIONAL
2026-03-01
2026-12-31
Brief Summary
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Detailed Description
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Study Design and Setting: A prospective, randomized, double-blind, single-center, clinical trial will be conducted in emergency department of a tertiary care university hospital.
Statistical Analysis:
Categorical variables will be presented as numbers and percentages. The Kolmogorov-Smirnov test will be used to evaluate the normality of the distribution of continuous variables. Continuous variables with a non-normal distribution will be expressed as the median and interquartile range (IQR), and those with a normal distribution will be expressed as the mean and standard deviation (SD). The Mann-Whitney U test will be used to analyse non-normally distributed variables to evaluate the differences in visual analog scale scores between the two groups; the Student's t-test will be used for normally distributed variables.
The sample size was calculated using the G\*Power 3.1.9.2 programme. According to the data obtained from the study of renal colic therapy with TENS, a difference of 18.4 mm in visual analogue scale score between the two groups with a standard deviation of 6 mm was assumed. It was calculated that 64 patients were required for each group with a two-sided critical value of α = 0.05, 95% power and an effect size of 0.5.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Real Transcutaneous electrical nerve stimulation (TENS)
Patients receiving the real transcutaneous electrical nerve stimulation (TENS) with 100 hertz, pulse width 200 microseconds, voltage 2 milliampere
TENS
Transcutaneous electrical nerve stimulation (TENS) treatment will be activated + NS IV Infusion 100 ml
dexketoprofen trometamol
50 mg dexketoprofen trometamol
Dexketoprofen Trometamol
50 mg dexketoprofen trometamol in 100 ml normal saline solution + Transcutaneous electrical nerve stimulation treatment will not be activated.
Interventions
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TENS
Transcutaneous electrical nerve stimulation (TENS) treatment will be activated + NS IV Infusion 100 ml
Dexketoprofen Trometamol
50 mg dexketoprofen trometamol in 100 ml normal saline solution + Transcutaneous electrical nerve stimulation treatment will not be activated.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnant women
* Breastfeeding women
* Haemodynamically unstable
* Evidence of peritoneal inflammation
* Patients who were taking analgesics at the time of initial presentation
* Unconsciousness or inability to communicate
* Contraindications to applying TENS or using the drug in the study.
18 Years
ALL
No
Sponsors
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Adiyaman University Research Hospital
OTHER
Responsible Party
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Umut Gulacti
Professor
Principal Investigators
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Umut Gulacti, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Adiyaman University of Medical Faculty
Locations
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Adiyaman University Medical Faculty
Adıyaman, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Umut Gulacti, Prof.Dr.
Role: primary
References
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Gulacti U, Algin A, Turgut K, Yavuz E, Aydin I, Buyukaslan H, Lok U, Arslan E, Gonel A. Transcutaneous Electrical Nerve Stimulation (TENS) for the Treatment of Renal Colic in the ED: A Randomized, Double-Blind, Placebo-Controlled Trial. Am J Emerg Med. 2022 Jun;56:127-132. doi: 10.1016/j.ajem.2022.02.044. Epub 2022 Mar 29.
Al B, Sunar MM, Zengin S, Sabak M, Bogan M, Can B, Kul S, Murat Oktay M, Eren SH. Comparison of IV dexketoprofen trometamol, fentanyl, and paracetamol in the treatment of renal colic in the ED: A randomized controlled trial. Am J Emerg Med. 2018 Apr;36(4):571-576. doi: 10.1016/j.ajem.2017.09.019. Epub 2017 Sep 14.
Hanna M, Moon JY. A review of dexketoprofen trometamol in acute pain. Curr Med Res Opin. 2019 Feb;35(2):189-202. doi: 10.1080/03007995.2018.1457016. Epub 2018 Apr 24.
Other Identifiers
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RK-TENSE-2025-AEAH
Identifier Type: -
Identifier Source: org_study_id
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