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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real Transcutaneous electrical nerve stimulation (TENS) | Experimental | Patients receiving the real transcutaneous electrical nerve stimulation (TENS) with 100 hertz, pulse width 200 microseconds, voltage 2 milliampere |
|
| dexketoprofen trometamol | Active Comparator | 50 mg dexketoprofen trometamol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TENS | Device | Transcutaneous electrical nerve stimulation (TENS) treatment will be activated + NS IV Infusion 100 ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 15 minutes and 30 minutes after the administration of the study interventions |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | 30 minutes after the administration of the study interventions | 30 minutes after |
| need to rescue medication | 30 minutes after the administration of the study interventions |
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Inclusion Criteria:
- Aged 18 years or over with a definite diagnosis of renal colic
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Umut Gulacti, Prof.Dr. | Contact | +905355851900 | umutgulacti@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Umut Gulacti, Prof.Dr. | Adiyaman University of Medical Faculty | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adiyaman University Medical Faculty | Adıyaman | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35397352 | Background | 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. | |
| 29029797 |
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| ID | Term |
|---|---|
| D056844 | Renal Colic |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| C118296 | dexketoprofen trometamol |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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|
| Dexketoprofen Trometamol | Drug | 50 mg dexketoprofen trometamol in 100 ml normal saline solution + Transcutaneous electrical nerve stimulation treatment will not be activated. |
|
|
| 30 minutes after |
| 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. |
| 29569951 | Background | 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. |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |