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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|ClinicalTrials.gov Identifier: NCT01906762|
Recruitment Status : Completed
First Posted : July 24, 2013
Last Update Posted : July 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|Renal Colic||Drug: Acetaminophen Drug: Morphine||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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 Start Date :||July 2012|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||April 2013|
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.
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.
Other Name: Apotel
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.
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.
Other Name: Morphine Sulfate
- Pain [ Time Frame: 30 Minutes ]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.