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

Not Applicable

Not yet recruiting

• Conditions: Renal Colic
• Interventions: Device: TENS; Drug: Dexketoprofen Trometamol

• Registration Number: NCT07176572
• Lead Sponsor: Adiyaman University Research Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-10
• Study First Submitted QC: 2025-09-10
• Last Update Submitted: 2025-09-10
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16
• Study Start: 2026-03-01
• Primary Completion: 2026-09-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

Patients aged 18 and over with acute renal colic due to urinary system stones who definitively diagnosed using unenhanced computed abdominopelvic tomography.

Exclusion Criteria

Patients who did not sign the informed consent form and agreed to participate in the study.

Pregnant or breastfeeding women Patients who were haemodynamically unstable. Patients with evidence of peritoneal inflammation. Patients who received opioids or other analgesics at the time of initial presentation.

Patients with impaired consciousness or those unable to communicate. Patients with conditions that contraindicate TENS application or the drug used in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Real Transcutaneous electrical nerve stimulation (TENS)	TENS	Patients receiving the real transcutaneous electrical nerve stimulation (TENS) with 100 hertz, pulse width 200 microseconds, voltage 2 milliampere
dexketoprofen trometamol	Dexketoprofen Trometamol	50 mg dexketoprofen trometamol

Primary Outcome Measures

Name	Time	Method
Change of the intensity of pain	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 Outcome Measures

Name	Time	Method
Adverse events	30 minutes after	30 minutes after the administration of the study interventions
need to rescue medication	30 minutes after	30 minutes after the administration of the study interventions

Trial Locations

Locations (1)

Adiyaman University Medical Faculty; Adıyaman, Turkey (Türkiye)