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

Phase 3

Completed

• Conditions: Multiple Trauma; Acute Pain Due to Trauma
• Interventions: Drug: Ibuprofen 800 mg; Drug: Morphine Sulfate; Drug: Ibuprofen 400 mg plus Acetaminophen 1000 mg

• Registration Number: NCT05630222
• Lead Sponsor: Isfahan University of Medical Sciences

Brief 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.

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 Timeline

• Study Start: 2022-03-15
• Study First Submitted: 2022-11-18
• Study First Submitted QC: 2022-11-18
• Study First Posted: 2022-11-29
• Primary Completion: 2023-02-15
• Study Completion: 2023-03-15
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibuprofen	Ibuprofen 800 mg	Ibuprofen 800 mg IV infusion over 20 min.
Morphine	Morphine Sulfate	Morphine Sulfate 0.1 mg/kg IV
Ibuprofen plus Acetaminophen	Ibuprofen 400 mg plus Acetaminophen 1000 mg	Ibuprofen 400 mg plus Acetaminophen 1000 mg IV infusion over 20 min.

Primary Outcome Measures

Name	Time	Method
Visual analogue score (VAS)	Change from baseline at 60 minutes	a scale for measuring the extent of pain relief

Secondary Outcome Measures

Name	Time	Method
HR	Change from baseline at 60 minutes	Heart rate
RR	Change from baseline at 60 minutes	Respiratory rate
SpO2	Change from baseline at 60 minut	Blood oxygen saturation
BP	Change from baseline at 60 minut	Blood Pressure

Trial Locations

Locations (1)

Al-Zahra University Hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of