Evaluation of Effect of Intravenous Morphine vs Intravenous Ibuprofen and Acetaminophen vs Intravenous Ibuprofen

Evaluation of Effect of Intravenous Morphine vs Intravenous Ibuprofen and Acetaminophen vs Intravenous Ibuprofen on Pain Relief in Patients With Closed Extremity Fracture Admitted in Alzahra and Ayatollah Kashani Hospitals in 2022

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.

Study Overview

• Status: Completed
• Conditions: Multiple Trauma; Acute Pain Due to Trauma
• Intervention / Treatment: Drug: Ibuprofen 800 mg; Drug: Morphine Sulfate; Drug: Ibuprofen 400 mg plus Acetaminophen 1000 mg

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Isfahan, Iran, Islamic Republic of, 81389387
    • Al-Zahra University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ibuprofen; Ibuprofen 800 mg IV infusion over 20 min.	Drug: Ibuprofen 800 mg; Ibuprofen from Caspian Taamin Company
Active Comparator: Morphine; Morphine Sulfate 0.1 mg/kg IV	Drug: Morphine Sulfate; Morphine Sulfate from Darupakhsh Company
Active Comparator: Ibuprofen plus Acetaminophen; Ibuprofen 400 mg plus Acetaminophen 1000 mg IV infusion over 20 min.	Drug: Ibuprofen 400 mg plus Acetaminophen 1000 mg; Both from Caspian Taamin Company

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue score (VAS)	a scale for measuring the extent of pain relief	Change from baseline at 60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HR	Heart rate	Change from baseline at 60 minutes
RR	Respiratory rate	Change from baseline at 60 minutes
SpO2	Blood oxygen saturation	Change from baseline at 60 minut
BP	Blood Pressure	Change from baseline at 60 minut

Collaborators and Investigators

• Sponsor: Isfahan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Actual): February 15, 2023
• Study Completion (Actual): March 15, 2023

Study Registration Dates

• First Submitted: November 18, 2022
• First Submitted That Met QC Criteria: November 18, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Acute Pain; Multiple Trauma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Acetaminophen; Morphine; Ibuprofen
• Other Study ID Numbers: 3401308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It will be possible to share data if requeste
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No