Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05630222
Other study ID # 3401308
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 15, 2022
Est. completion date March 15, 2023

Study information

Verified date September 2023
Source Isfahan University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Pain is an inseparable symptom of fractures and is the most important and common symptom that brings patients to medical centers; Therefore, paying attention to pain and its control is very important in the examination and treatment of fractures, and painkillers are usually needed for effective pain control. About 70-90% of the patients who go to the emergency room due to injuries have organ injuries. Among these patients, those who suffer from fractures endure severe pain, and since only 10% of patients have open fractures, the pain management of patients with closed fractures is particularly important. Various medicinal compounds have been used so far to control the pain of fractured patients, including opioid compounds such as morphine, non-steroidal anti-inflammatory drugs such as ibuprofen and acetaminophen. Opioids are the main drug class for pain control in fractures, but since they have significant side effects, various studies have been conducted in the field of comparing the anti-inflammatory effect of different drugs in fractures, and the effect of various combinations compared to opioids has been investigated. Non-steroidal anti-inflammatories are always considered as an alternative to opioids and acetaminophen has also been considered to reduce the dosage of opioids, so in this study the effect of three combinations of intravenous morphine and ibuprofen plus intravenous acetaminophen and intravenous ibuprofen on pain levels in patients with a closed limb fracture will be investigated. This study is a blind randomized clinical trial, which investigates and compares the effect of intravenous morphine (Daropakhsh Company) with intravenous ibuprofen (Caspian Taamin Company) and intravenous acetaminophen (Caspian Taamin Company) with intravenous ibuprofen (Caspian Taamin Company) in reducing the pain of patients with closed limb fractures. The population investigated in this study will include all patients referred to the emergency room of Al-Zahra and Ayatollah Kashani educational centers in Isfahan city in 2022-2023.


Description:

The study subjects are classified into 3 groups by computerized random allocation method, the first group will receive 0.1 mg/kg of intravenous morphine (Daropakhsh company) and the second group will take 400 mg of intravenous ibuprofen (Caspian Taamin company) plus 1 gram of intravenous acetaminophen (Caspian company). Tamin) and the third group receives 800 mg of intravenous ibuprofen (Caspian Taamin Company).This study is a blind randomized clinical trial, which investigates and compares the effect of intravenous morphine with intravenous ibuprofen and intravenous acetaminophen with intravenous ibuprofen.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date March 15, 2023
Est. primary completion date February 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Diagnosing a closed fracture of any of the bones of the body by an emergency medicine specialist - Informed consent of the patient or his family to participate in the study - Age 18 to 55 years - Pain score of higher than or equal to 6 on the VAS scale - Informed consent of the patient or family during the study - No history of liver or kidney failure - No history of gastrointestinal bleeding - No history of heart failure - No history of allergy to study drugs - Absence of addiction (the patient is asked) - Not decreased level of consciousness - Lack of evidence of increased intra-cerebral pressure - Not having an open fracture - Absence of breathing disorders and respiratory problems - No history of asthma - Lack of history of frequent use of painkillers - Not receiving any form of pain killer in the last few hours Exclusion Criteria: - Occurrence of any type of drug reaction or unusual complication during the study period - Simultaneous Head trauma - Simultaneous damage of nerves and blood vessels - Multiple fractures - Fracture other than limb - Evidence of increased intra-cerebral pressure - Decreased level of consciousness - Breathing disorders and respiratory problems

Study Design


Intervention

Drug:
Ibuprofen 800 mg
Ibuprofen from Caspian Taamin Company
Morphine Sulfate
Morphine Sulfate from Darupakhsh Company
Ibuprofen 400 mg plus Acetaminophen 1000 mg
Both from Caspian Taamin Company

Locations

Country Name City State
Iran, Islamic Republic of Al-Zahra University Hospital Isfahan

Sponsors (1)

Lead Sponsor Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual analogue score (VAS) a scale for measuring the extent of pain relief Change from baseline at 60 minutes
Secondary HR Heart rate Change from baseline at 60 minutes
Secondary RR Respiratory rate Change from baseline at 60 minutes
Secondary SpO2 Blood oxygen saturation Change from baseline at 60 minut
Secondary BP Blood Pressure Change from baseline at 60 minut
See also
  Status Clinical Trial Phase
Recruiting NCT02682550 - Danger Response in Polytrauma Patients N/A
Completed NCT03634215 - Estimation of Coagulation Factor XIII Activity Based on the Initial Plasma Fibrinogen Level in Trauma
Completed NCT01669577 - Independent Predictors of Mortality in Polytrauma Patients Phase 3
Completed NCT00872690 - Factors Affecting Return to Work Among OEF/OIF Veterans With Polytrauma N/A
Recruiting NCT04588311 - ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients Phase 3
Terminated NCT00613392 - Antioxidant Supplementation in Trauma Patients Phase 3
Completed NCT02917694 - A Feasibility Study to Assess Pre Admission Status and Six Month Outcomes After Major Trauma
Recruiting NCT05386199 - The Role of Serotonin in Intensive Care Patients
Recruiting NCT02727946 - Tissue Perfusion Indices as Predictor of Outcome in Poly Trauma Patients N/A
Completed NCT03480555 - Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients N/A
Recruiting NCT03368092 - Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe Trauma Phase 3
Recruiting NCT01240291 - The Clinical Role of Intravenous Glutamine in Trauma Patients Receiving Enteral Nutrition Phase 3
Not yet recruiting NCT01074112 - Keller Prehospital Ultrasound Study N/A
Completed NCT00163826 - Spinal Clearance Study: Expediting the Spinal Clearance Process in the Major Trauma Patient Phase 4
Terminated NCT03489577 - The Role of Post-traumatic Inhibition of the Innate and Adaptive Immune System in the Development of Infectious Complications in Severely Injured Patients
Terminated NCT01477697 - Effects of Omega-3 Fatty Acid Supplementation on Inflammatory Response in Multisystem Trauma Patients Phase 1/Phase 2
Completed NCT01373996 - Clinical Investigation of Wireless Transmission of Invasive Blood Pressure Signal N/A
Completed NCT03154424 - Dynamic External Fixation in Treatment Distal Radius Fractures - Elderly Patients N/A
Recruiting NCT00459160 - A Comparison of Two Target Mean Arterial Pressures in the Resuscitation of Hypotensive Trauma Patients N/A
Recruiting NCT00622934 - Relationship Between Erythropoietin Administration and Stress Responses in Trauma Patients Phase 2