Comparison of the Analgesic Efficacy of Dexketoprofen Trometamol, Meperidine, and Paracetamol in Renal Colic

NCT06558916 | Completed Phase 4

• 1 other identifier: ErciyesUniversity-IT01
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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 mcg/kg, intravenously) as a rescue drug.

Conditions

Analgesia; Renal Colic

Keywords

Analgesic efficacy; Dexketoprofen trometamol; Emergency department; Meperidine; Paracetamol; Renal colic

Outcome Measures

Primary Outcomes (1)

• VAS score change at the 30th minute

  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.

  0th minute and 30th minute

Study Arms (3)

Dexketoprofen trometamol

EXPERIMENTAL

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) was prepared as a 250 mL solution in standard saline, with the same appearance. The drugs were given as a single dose over 15 minutes.

Drug: Dexketoprofen Trometamol; Drug: Fentanyl

Meperidine

EXPERIMENTAL

The study drugs were administered to patients suspected of having renal colic in random order: meperidine IV 50 mg (Aldolan 100 mg ampoule) was prepared as a 250 mL solution in standard saline, with the same appearance. The drugs were given as a single dose over 15 minutes.

Drug: Meperidine Injectable Solution; Drug: Fentanyl

Paracetamol

EXPERIMENTAL

The study drugs were administered to patients suspected of having renal colic in random order: paracetamol IV 1000 mg (Perfalgan 10 mg/mL infusion solution) was prepared as a 250 mL solution in standard saline, with the same appearance.The drugs were given as a single dose over 15 minutes.

Drug: Paracetamol; Drug: Fentanyl

Interventions

Dexketoprofen Trometamol DRUG

Also known as: Arveles, Dexalgin

Dexketoprofen trometamol

Meperidine Injectable Solution DRUG

Also known as: Pethidine, Aldolan

Meperidine

Paracetamol DRUG

Also known as: Acetaminophen, Parol

Paracetamol

Fentanyl DRUG

Patients with a VAS score of 40 mm or higher at the 30th minute were given fentanyl (1 mcg/kg, intravenously) as a rescue drug.

Also known as: Sublimaze

Dexketoprofen trometamol; Meperidine; Paracetamol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 65.
• Diagnosed with renal colic via anamnesis, physical examination, laboratory, and imaging tests.
• Provided informed consent to participate in the research.
• Both genders.

You may not qualify if:

• Recent intake of any analgesic medication within six hours prior to arrival.
• Regular medication schedule.
• Age under 18 or over 65.
• Hemodynamically unstable patients.
• Renal, hepatic, cardiac, or respiratory failure.
• Allergies to study drugs.
• Pregnant or breastfeeding women.
• History of renal transplantation.
• Presence of only one kidney.
• Serum creatinine levels exceeding 2 mg/dL.
• History of gastrointestinal bleeding or peptic ulcer.
• Inability to complete the pain scale due to vision problems.

Sponsors & Collaborators

• Ismail Tekin: lead
• TC Erciyes University: collaborator

MeSH Terms

Conditions

Agnosia; Renal Colic; Emergencies

Interventions

dexketoprofen trometamol; Meperidine; Acetaminophen; Fentanyl

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Isonipecotic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ismail Tekin

  Primary Health Care Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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 with the same appearance. The nurse who prepared the solution was informed about the study, but the nurse who administered the drug did not know which group the patient was in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.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 mg/mL infusion solution) was prepared as a 250 mL solution in standard saline, with the same appearance. The drugs were given as a single dose over 15 minutes.

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 19, 2024
• Study Start: October 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share