Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06558916
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Comparison of the Analgesic Efficacy of Dexketoprofen Trometamol Meperidine and Paracetamol in Renal Colic
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of the Analgesic Efficacy of Dexketoprofen Trometamol Meperidine and Paracetamol in Patients Presenting With Renal Colic
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aimed to compare the effectiveness of intravenous IV dexketoprofen trometamol IV meperidine and IV paracetamol as analgesics for renal colic in patients at the Emergency Department of Erciyes University Medical School The double-blind randomized trial included 90 patients aged 18-65 years Patients were divided into three groups of 30 receiving 50 mg IV dexketoprofen trometamol 50 mg IV meperidine or 1000 mg IV paracetamol administered in 250 mL of saline over 15 minutes Pain intensity was measured at 15 30 and 60 minutes post-administration using a 100-mm visual analog scale VAS and a 4-point verbal rating scale VRS Successful treatment was defined as a 50 or greater reduction in VAS score at 30 minutes Patients with a VAS score of 40 mm or higher at the 30th minute were given fentanyl 1 mcgkg intravenously as a rescue drug
Detailed Description:
Study design
This clinical trial was conducted at a single center involving a prospective randomized double-blind study The main objective was to compare the analgesic effectiveness of three different medications-IV dexketoprofen trometamol IV meperidine and IV paracetamol in patients who arrived at the emergency department with renal colic
Selection of participants
Patients who had taken any analgesic medication in the six hours preceding their arrival those who had a regular medication schedule individuals under 18 years of age or over 65 hemodynamically unstable patients patients with renal hepatic cardiac or respiratory failure those allergic to the drugs used in the study pregnant or breastfeeding women those with a history of renal transplantation patients with only one kidney individuals with serum creatinine levels exceeding 2 mgdL those with a history of gastrointestinal bleeding and peptic ulcer and patients unable to fill out the pain scale due to vision problems were excluded from the study
The patients were randomized and numbered using a computer Ninety eligible patients diagnosed with renal colic and who agreed to participate in the study were included Thirty patients were assigned to each of the three groups-dexketoprofen trometamol meperidine and paracetamol
Interventions
All patients who presented to our emergency department with symptoms and signs indicative of renal colic were interviewed to gather information on their medical history A detailed physical examination was then performed and exclusion criteria were assessed The patients were informed about the study and consent was obtained Vascular access was established for all patients and Complete Blood Count CBC Blood Urea Nitrogen BUN Creatinine Sodium Potassium and Aspartate aminotransferase AST Alanine transaminase ALT and urinalysis tests were requested for diagnosis and differential diagnosis During the blood draw the physician who evaluated the patient ordered the analgesic X Before the evaluation the patients were informed about the pain scales to be used in the study namely the visual analog scale VAS and verbal rating scale VRS The patients then made VAS and VRS markings on the evaluation forms without looking at the previous marking location Neither the patients nor the physicians knew which study group they were in during the clinical practice phase as the study was double-blind
The study drugs were administered to patients suspected of having renal colic in random order dexketoprofen trometamol IV 50 mg ampoule containing Dexalgin 50 mg injectable solution meperidine IV 50 mg Aldolan 100 mg ampoule and paracetamol IV 1000 mg Perfalgan 10 mgmL infusion solution was prepared as a 250 mL solution in standard saline with the same appearance The nurse who administered the drug was informed about the study but the nurse who prepared the solution did not know which group the patient was in The drugs were given as a single dose over 15 minutes
Direct Urinary System X-ray and Urinary Ultrasound Sonography USG were conducted to detect stones and signs of urinary system obstruction in patients with renal colic In cases where the diagnosis of renal colic was unclear Computed Tomography was conducted for diagnosis and differential diagnosis The study included 90 patients of both genders aged between 18 and 65 who were diagnosed with renal colic after anamnesis physical examination laboratory and imaging tests and who gave their consent to participate in the research Statistical analyses were then performed
If any unexpected effect was observed in the patients during the study period the patient did not accept the treatment or wanted to leave the study such patients were excluded from the study in the preparation phase Fortunately no such situation was encountered during the follow-ups
Methods of measurements
The time at which treatment began was recorded as 0th minutes and pain levels were measured using the VAS scale which ranges from 0 mm no pain to 100 mm unbearable pain The pain levels were measured before treatment and at the 15th 30th and 60th minutes after the treatment Pain severity was evaluated using VRS and classified as none-mild-moderate-severe
A treatment was considered successful if there was a 50 or greater reduction in the VAS score at the 30th minute 8 If a patients VAS score was 40 mm at the 30th minute they were given 1 mcgkg of Fentanyl IV as a rescue medication All patients were monitored for at least 60 minutes and any side effects and vital signs were recorded during this period
Data analysis
Statistical analysis conducted in this study involved the use of various methods such as t-test independent samples one-way variance analysis and variance analysis in repeated measurements The categorical variables were analyzed using the chi-square test The numerical variables were expressed as arithmetic mean standard deviation mean SD Any p-value less than 005 was considered statistically significant The statistical analysis was performed using version 22 of the SPSS for Windows package program IBM Armonk NY United States
This clinical trial was conducted at a single center involving a prospective randomized double-blind study The main objective was to compare the analgesic effectiveness of three different medications-IV dexketoprofen trometamol IV meperidine and IV paracetamol in patients who arrived at the emergency department with renal colic
Selection of participants
Patients who had taken any analgesic medication in the six hours preceding their arrival those who had a regular medication schedule individuals under 18 years of age or over 65 hemodynamically unstable patients patients with renal hepatic cardiac or respiratory failure those allergic to the drugs used in the study pregnant or breastfeeding women those with a history of renal transplantation patients with only one kidney individuals with serum creatinine levels exceeding 2 mgdL those with a history of gastrointestinal bleeding and peptic ulcer and patients unable to fill out the pain scale due to vision problems were excluded from the study
The patients were randomized and numbered using a computer Ninety eligible patients diagnosed with renal colic and who agreed to participate in the study were included Thirty patients were assigned to each of the three groups-dexketoprofen trometamol meperidine and paracetamol
Interventions
All patients who presented to our emergency department with symptoms and signs indicative of renal colic were interviewed to gather information on their medical history A detailed physical examination was then performed and exclusion criteria were assessed The patients were informed about the study and consent was obtained Vascular access was established for all patients and Complete Blood Count CBC Blood Urea Nitrogen BUN Creatinine Sodium Potassium and Aspartate aminotransferase AST Alanine transaminase ALT and urinalysis tests were requested for diagnosis and differential diagnosis During the blood draw the physician who evaluated the patient ordered the analgesic X Before the evaluation the patients were informed about the pain scales to be used in the study namely the visual analog scale VAS and verbal rating scale VRS The patients then made VAS and VRS markings on the evaluation forms without looking at the previous marking location Neither the patients nor the physicians knew which study group they were in during the clinical practice phase as the study was double-blind
The study drugs were administered to patients suspected of having renal colic in random order dexketoprofen trometamol IV 50 mg ampoule containing Dexalgin 50 mg injectable solution meperidine IV 50 mg Aldolan 100 mg ampoule and paracetamol IV 1000 mg Perfalgan 10 mgmL infusion solution was prepared as a 250 mL solution in standard saline with the same appearance The nurse who administered the drug was informed about the study but the nurse who prepared the solution did not know which group the patient was in The drugs were given as a single dose over 15 minutes
Direct Urinary System X-ray and Urinary Ultrasound Sonography USG were conducted to detect stones and signs of urinary system obstruction in patients with renal colic In cases where the diagnosis of renal colic was unclear Computed Tomography was conducted for diagnosis and differential diagnosis The study included 90 patients of both genders aged between 18 and 65 who were diagnosed with renal colic after anamnesis physical examination laboratory and imaging tests and who gave their consent to participate in the research Statistical analyses were then performed
If any unexpected effect was observed in the patients during the study period the patient did not accept the treatment or wanted to leave the study such patients were excluded from the study in the preparation phase Fortunately no such situation was encountered during the follow-ups
Methods of measurements
The time at which treatment began was recorded as 0th minutes and pain levels were measured using the VAS scale which ranges from 0 mm no pain to 100 mm unbearable pain The pain levels were measured before treatment and at the 15th 30th and 60th minutes after the treatment Pain severity was evaluated using VRS and classified as none-mild-moderate-severe
A treatment was considered successful if there was a 50 or greater reduction in the VAS score at the 30th minute 8 If a patients VAS score was 40 mm at the 30th minute they were given 1 mcgkg of Fentanyl IV as a rescue medication All patients were monitored for at least 60 minutes and any side effects and vital signs were recorded during this period
Data analysis
Statistical analysis conducted in this study involved the use of various methods such as t-test independent samples one-way variance analysis and variance analysis in repeated measurements The categorical variables were analyzed using the chi-square test The numerical variables were expressed as arithmetic mean standard deviation mean SD Any p-value less than 005 was considered statistically significant The statistical analysis was performed using version 22 of the SPSS for Windows package program IBM Armonk NY United States
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None