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

NCT05630222 | Completed Phase 3

• 1 other identifier: 3401308
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Trauma; Acute Pain Due to Trauma

Outcome Measures

Primary Outcomes (1)

• Visual analogue score (VAS)

  a scale for measuring the extent of pain relief

  Change from baseline at 60 minutes

Secondary Outcomes (4)

• HR

  Change from baseline at 60 minutes

• RR

  Change from baseline at 60 minutes

• SpO2

  Change from baseline at 60 minut

• BP

  Change from baseline at 60 minut

Study Arms (3)

Ibuprofen

ACTIVE COMPARATOR

Ibuprofen 800 mg IV infusion over 20 min.

Drug: Ibuprofen 800 mg

Morphine

ACTIVE COMPARATOR

Morphine Sulfate 0.1 mg/kg IV

Drug: Morphine Sulfate

Ibuprofen plus Acetaminophen

ACTIVE COMPARATOR

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

Drug: Ibuprofen 400 mg plus Acetaminophen 1000 mg

Interventions

Ibuprofen 800 mg DRUG

Ibuprofen from Caspian Taamin Company

Ibuprofen

Morphine Sulfate DRUG

Morphine Sulfate from Darupakhsh Company

Morphine

Ibuprofen 400 mg plus Acetaminophen 1000 mg DRUG

Both from Caspian Taamin Company

Ibuprofen plus Acetaminophen

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Al-Zahra University Hospital

Isfahan, 81389387, Iran

Location

Related Publications (1)

• 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.

  PMID: 38273252 DERIVED

MeSH Terms

Conditions

Multiple Trauma

Interventions

Ibuprofen; Morphine; Acetaminophen

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: November 29, 2022
• Study Start: March 15, 2022
• Primary Completion: February 15, 2023
• Study Completion: March 15, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

IR (1)