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Efficacy of Intravenous (IV) Paracetamol for Treatment of Acute Pain

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ClinicalTrials.gov Identifier: NCT01465984
Recruitment Status : Completed
First Posted : November 7, 2011
Last Update Posted : December 10, 2012
Information provided by (Responsible Party):
Tehran University of Medical Sciences

Brief Summary:
The purpose of this study is to determine whether Iv paracetamol is as effective as Iv Morphine sulfate on control of the acute pain in Patient with limb trauma.

Condition or disease Intervention/treatment Phase
Acute Pain Drug: Paracetamol Phase 4

Detailed Description:

Limb trauma is a painful condition that requires urgent analgesic treatment . Intravenous Opioids and NSAIDs are used extensively to control pain; both of them are with side effects. Paracetamol is a safe and effective analgesic that is used by oral or rectal routs for pain control, and in therapeutic doses has less side effects than Morphine and NSAIDs, and approved as a safe and effective analgesic in emergency department.

recently Iv Paracetamol has become available in European countries and also in Iran.

efficacy and safety of IV Paracetamol has been studied in post operation conditions and asserted but in emergency setting it has been studied only in renal colic situation.

Therefore, the investigators want to study the efficacy of IV Paracetamol in limb trauma and compare it with Iv Morphine sulfate.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of IV Paracetamol With Intravenous Morphine Sulfate in Treatment of Acute Pain Due to Limb Trauma
Study Start Date : November 2011
Primary Completion Date : September 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: IV Paracetamol Drug: Paracetamol
paracetamol , 1 gram Iv infusion Morphine Sulfate0.1 Mg/Kg Iv
Active Comparator: IV Morphine Sulfate Drug: Paracetamol
paracetamol , 1 gram Iv infusion Morphine Sulfate0.1 Mg/Kg Iv

Primary Outcome Measures :
  1. Change in pain severity/score [ Time Frame: after 30 minutes ]

Secondary Outcome Measures :
  1. Need for rescue analgesia [ Time Frame: After 30 minutes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of acute limb trauma
  • Age>=18 years
  • Acute pain of score 3 or greater on visual analogue scale

Exclusion Criteria:

  • Unstable hemodynamic (Systolic blood pressure under 90 mmHg)
  • Known sensitivity to opioids or paracetamol
  • Any other known contraindication to Morphine Sulfate or Iv Paracetamol (including severe allergy to these drugs, acute bronchial asthma, upper respiratory tract obstruction)
  • Previous administration of analgesic during 6 hours ago
  • Pregnant women
  • previous inclusion to the study
  • diagnosed heart failure
  • renal failure
  • pulmonary failure or hepatic failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01465984

Iran, Islamic Republic of
Tehran, Iran, Islamic Republic of, 1417613151
Sponsors and Collaborators
Tehran University of Medical Sciences
Study Director: Mohammad Jalili, MD TUMS

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01465984     History of Changes
Other Study ID Numbers: ACET1390
TUMS Thesis 1389 ( Other Grant/Funding Number: TUMS )
First Posted: November 7, 2011    Key Record Dates
Last Update Posted: December 10, 2012
Last Verified: December 2012

Keywords provided by Tehran University of Medical Sciences:
Morphine sulfates
Acute pain

Additional relevant MeSH terms:
Acute Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic