Renal Colic
Conditions
Keywords
Transcutaneous electrical nerve stimulation, emergency medicine, Dexketoprofen Trometamol
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.
Interventions
DEVICETENS
Transcutaneous electrical nerve stimulation (TENS) treatment will be activated + NS IV Infusion 100 ml
50 mg dexketoprofen trometamol in 100 ml normal saline solution + Transcutaneous electrical nerve stimulation treatment will not be activated.
Sponsors
Adiyaman University Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Turkey (Türkiye)
Contacts
Primary ContactUmut Gulacti, Prof.Dr.
Outcome results
None listed