A Phase 4 interventional study of TENS and Dexketoprofen Trometamol in Renal Colic, sponsored by Adiyaman University Research Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-02.
Sponsored by Adiyaman University Research Hospital · Phase 4, Interventional, and Treatment
The aim of this study was to compare the analgesic efficacy of transcutaneous electrical nerve stimulation (TENS) and dexketoprofen trometamol in patients presenting to the emergency department due to renal colic.
Renal colic is a common presenting complaint to the emergency department and is an intensely painful condition. Parenteral opioids, non-steroidal anti-inflammatory drugs (NSAIDs) and paracetamol are commonly used to relieve the pain of renal colic. Dexketoprofen trometamol is a non-steroidal anti-inflammatory drug that is frequently used in the management of acute pain. Common and known side effects of nonsteroidal anti-inflammatory drugs include gastrointestinal system problems and allergic reactions. Transcutaneous electrical nerve stimulation is a non-invasive, non-pharmacological and low-risk treatment method. This study aimed to compare the analgesic efficacy of Transcutaneous electrical nerve stimulation and dexketoprofen trometamol in patients presenting to the emergency department with renal colic.
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.
79 studies on the registry are indexed under Renal Colic; 10 are open to participants now.
This study's planned enrollment of 128 is close to the median of 118 across 60 interventional studies indexed under Renal Colic.
Browse Renal Colic studies →Adiyaman University Research Hospital is the lead sponsor of 51 studies on the registry; 11 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- Aged 18 years or over with a definite diagnosis of renal colic
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receiving the real transcutaneous electrical nerve stimulation (TENS) with 100 hertz, pulse width 200 microseconds, voltage 2 milliampere
Device: TENS
50 mg dexketoprofen trometamol
Drug: Dexketoprofen Trometamol
Transcutaneous electrical nerve stimulation (TENS) treatment will be activated + NS IV Infusion 100 ml
Also known as: Comfort plus TENS device
50 mg dexketoprofen trometamol in 100 ml normal saline solution + Transcutaneous electrical nerve stimulation treatment will not be activated.
Also known as: Ketavel (dexketoprofen trometamol)
Change of the intensity of pain
Pain intense will be measured by 100 mm visual analog scale (Zero; no pain and 100 mm; the worst pain) after 15th and 30th minutes later the administration of the study interventions
Time frame: 15 minutes and 30 minutes after the administration of the study interventions
Adverse events
30 minutes after the administration of the study interventions
Time frame: 30 minutes after
need to rescue medication
30 minutes after the administration of the study interventions
Time frame: 30 minutes after
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Adiyaman University Research Hospital