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

Primary Purpose

Multiple Trauma, Acute Pain Due to Trauma

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Ibuprofen 800 mg
Morphine Sulfate
Ibuprofen 400 mg plus Acetaminophen 1000 mg
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Trauma

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Al-Zahra University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Ibuprofen

Morphine

Ibuprofen plus Acetaminophen

Arm Description

Ibuprofen 800 mg IV infusion over 20 min.

Morphine Sulfate 0.1 mg/kg IV

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

Outcomes

Primary Outcome Measures

Visual analogue score (VAS)
a scale for measuring the extent of pain relief

Secondary Outcome Measures

HR
Heart rate
RR
Respiratory rate
SpO2
Blood oxygen saturation
BP
Blood Pressure

Full Information

First Posted
November 18, 2022
Last Updated
September 5, 2023
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05630222
Brief Title
Evaluation of Effect of Intravenous Morphine vs Intravenous Ibuprofen and Acetaminophen vs Intravenous Ibuprofen
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
February 15, 2023 (Actual)
Study Completion Date
March 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Trauma, Acute Pain Due to Trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ibuprofen
Arm Type
Active Comparator
Arm Description
Ibuprofen 800 mg IV infusion over 20 min.
Arm Title
Morphine
Arm Type
Active Comparator
Arm Description
Morphine Sulfate 0.1 mg/kg IV
Arm Title
Ibuprofen plus Acetaminophen
Arm Type
Active Comparator
Arm Description
Ibuprofen 400 mg plus Acetaminophen 1000 mg IV infusion over 20 min.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen 800 mg
Intervention Description
Ibuprofen from Caspian Taamin Company
Intervention Type
Drug
Intervention Name(s)
Morphine Sulfate
Intervention Description
Morphine Sulfate from Darupakhsh Company
Intervention Type
Drug
Intervention Name(s)
Ibuprofen 400 mg plus Acetaminophen 1000 mg
Intervention Description
Both from Caspian Taamin Company
Primary Outcome Measure Information:
Title
Visual analogue score (VAS)
Description
a scale for measuring the extent of pain relief
Time Frame
Change from baseline at 60 minutes
Secondary Outcome Measure Information:
Title
HR
Description
Heart rate
Time Frame
Change from baseline at 60 minutes
Title
RR
Description
Respiratory rate
Time Frame
Change from baseline at 60 minutes
Title
SpO2
Description
Blood oxygen saturation
Time Frame
Change from baseline at 60 minut
Title
BP
Description
Blood Pressure
Time Frame
Change from baseline at 60 minut

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Al-Zahra University Hospital
City
Isfahan
ZIP/Postal Code
81389387
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
It will be possible to share data if requeste

Learn more about this trial

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

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