Adiyaman University Medical Faculty
Adıyaman, Turkey (Türkiye)
NCT Number: NCT07176572
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 4
Adıyaman, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Transcutaneous electrical nerve stimulation (TENS) treatment will be activated + NS IV Infusion 100 ml
Other names: Comfort plus TENS device
50 mg dexketoprofen trometamol in 100 ml normal saline solution + Transcutaneous electrical nerve stimulation treatment will not be activated.
Other names: Ketavel (dexketoprofen trometamol)
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
Time frame: 30 minutes after
30 minutes after the administration of the study interventions
Time frame: 30 minutes after
30 minutes after the administration of the study interventions
Contact information is provided by the study sponsor or research team.
Adiyaman University Research Hospital
Other
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
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.
Published trials that share one or more normalized conditions with this study.
NCT06980727
Neurologic Manifestations, Pain
Monastir, Monastir Governorate, Tunisia
View Trial DetailsNCT07536594
Calculi, Female Urogenital Diseases
View Trial DetailsNCT04490343
Calculi, Deep Learning Reconstruction
Amiens, France
View Trial DetailsNCT05323175
Neurologic Manifestations, Pain
Stony Brook, New York, United States
View Trial Details