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NCT Number: NCT07176572

Analgesic Efficacy of Transcutaneous Electrical Nerve Stimulation and Dexketoprofen in Renal Colic

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Adiyaman University Medical Faculty

Adıyaman, Turkey (Türkiye)

Location contact

Ebru Kara

PRINCIPAL_INVESTIGATOR

Umut Gulacti, Prof.Dr.

CONTACT

+905355851900

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years or over with a definite diagnosis of renal colic

Exclusion criteria

  • Patients who refuse to participate in the study
  • 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.

Treatment and study plan

TENS

Device

Transcutaneous electrical nerve stimulation (TENS) treatment will be activated + NS IV Infusion 100 ml

Other names: Comfort plus TENS device

dexketoprofen trometamol

Drug

50 mg dexketoprofen trometamol in 100 ml normal saline solution + Transcutaneous electrical nerve stimulation treatment will not be activated.

Other names: Ketavel (dexketoprofen trometamol)

Primary outcomes

  1. Change of the intensity of pain

    Time frame: 15 minutes and 30 minutes after the administration of the study interventions

    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

Secondary outcomes

  1. Adverse events

    Time frame: 30 minutes after

    30 minutes after the administration of the study interventions

  2. need to rescue medication

    Time frame: 30 minutes after

    30 minutes after the administration of the study interventions

Study contacts

Contact information is provided by the study sponsor or research team.

Umut Gulacti, Prof.Dr.

CONTACT

[email protected]

+905355851900

Sponsors and collaborators

Lead sponsor

Adiyaman University Research Hospital

Other

Registry information

Official study title

Comparison of Analgesic Efficacy of Transcutaneous Electrical Nerve Stimulation and Dexketoprofen Trometamol in Patients Presenting to the Emergency Department With Renal Colic: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 16, 2025
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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