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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

Primary Purpose

Renal Colic

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Acetaminophen
Morphine
Sponsored by
Seyed Mehdi Pourafzali
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Colic focused on measuring Morphine, Acetaminophen, Renal colic, Emergency treatment

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 20, 2013
    Last Updated
    July 20, 2013
    Sponsor
    Seyed Mehdi Pourafzali
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    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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