Comparing the Analgesic Effect of Intravenous Acetaminophen and Morphine on Patients With Renal Colic Pain Reffering to the Emergency Department: A Randomized Controlled Trial
Primary Purpose
Renal Colic
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Acetaminophen
Morphine
Sponsored by
About this trial
This is an interventional treatment trial for Renal Colic focused on measuring Morphine, Acetaminophen, Renal colic, Emergency treatment
Eligibility Criteria
Inclusion Criteria:
- aged 15 to 80 years
- weight of 60 to 80 kilograms
- known case of renal colic based on physical examination and Ultrasonography
Exclusion Criteria:
- Addiction
- allergic to Opioids and Acetaminophen
- receiving any types of analgesic drugs within previous 6 hours
- known cases of Kidney transplantation
- Patients with known heart failure
- Patients with known Liver failure
- Patients with known Respiratory failure
- Patients with known Renal failure
- cases of Blindness and physical disabilities not able to communicate
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Acetaminophen
Morphine
Arm Description
Specified dosage for Acetaminophen was 15 mg/kg. so based on the patient's weight(averagely 70 kg), about 1gr Acetaminophen (one complete Apotel Ampule) was used.
Specified dosage for Morphine was 0.1 mg/kg. so based on the patient's weight(averagely 70 kg), about 7 mg Morphine was used.
Outcomes
Primary Outcome Measures
Pain
patient's pain was assessed by using a Visual Analog Scale Ruler, that rates the amount of pain from 0 to 10 based on patient's confession. Patient's pain was checked out twice: exactly before receiving the pain reliever, and 30 minutes later.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01906762
Brief Title
Comparing the Analgesic Effect of Intravenous Acetaminophen and Morphine on Patients With Renal Colic Pain Reffering to the Emergency Department: A Randomized Controlled Trial
Official Title
Comparing the Effect of Intravenous Morphine and Injectable Acetaminophen on Renal Colic Patients Presenting to the Emergency Department: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seyed Mehdi Pourafzali
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Kidney stone is one of the most common diseases in every human society and also Iran. What is normally used to treat renal colic pain is Intravenous Opioid with a variety of side effects including hypotension, respiratory depression and apnea, nausea and vomiting. Regarding less complications of Intravenous Acetaminophen, we aimed to compare it with Intravenous Morphine in management of renal colic pain.
Detailed Description
Kidney stone is one of the common diseases of human society which is demonstrated in the form of renal colic. Evidences indicate that renal colic is one of the mot painful conditions that require urgent pain relief treatment.
Patients suffering from renal colic do not usually recover from pain by using oral pain killers or rectal suppositories. Hence, a considerable percentage of these patients are admitted to the emergency department. A bothering and sharp pain is the most common characteristics of renal colic pain that wakes the patient up in the middle of the night. To achieve more relief, patients somehow take unusual positions such as squatting.
What are normally used as pain relievers in emergency department are Non-steroidal anti-inflammatory drugs (NSAIDs) and intravenous Opioids. However, both of these classes of drugs have many side effects.
Another point in this regard which is worthy to be mentioned is that some patients with renal colic complaint are drug addicted, so we have to administer higher dosage of analgesic drugs. According to the statistics provided by the US National Library website, the prevalence of kidney stones around the world in 2005 has been averagely around 140.1% which is considerable. This issue suggests more attention to the field of prevention and treatment.
According to the statistics of kidney stones incidence in Iran, 2.4 out of every 1000 people suffer from this pathologic condition whereas it differs from 0.5 to 2 in every 1000 ones in other countries.
Intravenous Acetaminophen has been imported to our country and introduced with the brand of Apotel. In this regard, we decided to compare the effect of Intravenous Acetaminophen and Morphine on renal colic pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Colic
Keywords
Morphine, Acetaminophen, Renal colic, Emergency treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acetaminophen
Arm Type
Experimental
Arm Description
Specified dosage for Acetaminophen was 15 mg/kg. so based on the patient's weight(averagely 70 kg), about 1gr Acetaminophen (one complete Apotel Ampule) was used.
Arm Title
Morphine
Arm Type
Experimental
Arm Description
Specified dosage for Morphine was 0.1 mg/kg. so based on the patient's weight(averagely 70 kg), about 7 mg Morphine was used.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Apotel
Intervention Description
This protocol prepared by a nurse and labeled as Drug A. Since the rapid injection of Acetaminophen can result in hypotension, therefore based on the Apotel Injection Instruction, it must be infused slowly within 15 minutes.
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
Morphine Sulfate
Intervention Description
This protocol was prepared by a nurse and labeled as Drug B. Since the rapid injection of Morphine can result in histamine release, therefore it must be infused slowly within 15 minutes. The nurse, who was in charge of infusing pain reliever, was unaware of the type of injected drug.
Primary Outcome Measure Information:
Title
Pain
Description
patient's pain was assessed by using a Visual Analog Scale Ruler, that rates the amount of pain from 0 to 10 based on patient's confession. Patient's pain was checked out twice: exactly before receiving the pain reliever, and 30 minutes later.
Time Frame
30 Minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged 15 to 80 years
weight of 60 to 80 kilograms
known case of renal colic based on physical examination and Ultrasonography
Exclusion Criteria:
Addiction
allergic to Opioids and Acetaminophen
receiving any types of analgesic drugs within previous 6 hours
known cases of Kidney transplantation
Patients with known heart failure
Patients with known Liver failure
Patients with known Respiratory failure
Patients with known Renal failure
cases of Blindness and physical disabilities not able to communicate
12. IPD Sharing Statement
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Comparing the Analgesic Effect of Intravenous Acetaminophen and Morphine on Patients With Renal Colic Pain Reffering to the Emergency Department: A Randomized Controlled Trial
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