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

NCT ID: NCT05630222

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2023-03-15

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.

Conditions

Multiple Trauma; Acute Pain Due to Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ibuprofen

Ibuprofen 800 mg IV infusion over 20 min.

Group Type: ACTIVE_COMPARATOR

Ibuprofen 800 mg

Intervention Type: DRUG

Ibuprofen from Caspian Taamin Company

Morphine

Morphine Sulfate 0.1 mg/kg IV

Group Type: ACTIVE_COMPARATOR

Morphine Sulfate

Intervention Type: DRUG

Morphine Sulfate from Darupakhsh Company

Ibuprofen plus Acetaminophen

Ibuprofen 400 mg plus Acetaminophen 1000 mg IV infusion over 20 min.

Group Type: ACTIVE_COMPARATOR

Ibuprofen 400 mg plus Acetaminophen 1000 mg

Intervention Type: DRUG

Both from Caspian Taamin Company

Interventions

Ibuprofen 800 mg

Ibuprofen from Caspian Taamin Company

Intervention Type: DRUG

Morphine Sulfate

Morphine Sulfate from Darupakhsh Company

Intervention Type: DRUG

Ibuprofen 400 mg plus Acetaminophen 1000 mg

Both from Caspian Taamin Company

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Isfahan University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Mehdi Nasr Isfahani

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Al-Zahra University Hospital

Isfahan, , Iran

Countries

Iran

References

Nasr Isfahani M, Etesami H, Ahmadi O, Masoumi B. Comparing the efficacy of intravenous morphine versus ibuprofen or the combination of ibuprofen and acetaminophen in patients with closed limb fractures: a randomized clinical trial. BMC Emerg Med. 2024 Jan 25;24(1):15. doi: 10.1186/s12873-024-00933-y.

Reference Type: DERIVED

PMID: 38273252 (View on PubMed)

Other Identifiers

3401308

Identifier Type: -

Identifier Source: org_study_id