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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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

November 2, 2011
November 7, 2011
December 10, 2012
November 2011
September 2012   (Final data collection date for primary outcome measure)
Change in pain severity/score [ Time Frame: after 30 minutes ]
Same as current
Complete list of historical versions of study NCT01465984 on Archive Site
Need for rescue analgesia [ Time Frame: After 30 minutes ]
Same as current
Not Provided
Not Provided
Efficacy of Intravenous (IV) Paracetamol for Treatment of Acute Pain
Comparison of IV Paracetamol With Intravenous Morphine Sulfate in Treatment of Acute Pain Due to Limb Trauma
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.

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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Pain
Drug: Paracetamol
paracetamol , 1 gram Iv infusion Morphine Sulfate0.1 Mg/Kg Iv
  • Experimental: IV Paracetamol
    Intervention: Drug: Paracetamol
  • Active Comparator: IV Morphine Sulfate
    Intervention: Drug: Paracetamol
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2012
September 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
TUMS Thesis 1389 ( Other Grant/Funding Number: TUMS )
Not Provided
Not Provided
Tehran University of Medical Sciences
Tehran University of Medical Sciences
Not Provided
Study Director: Mohammad Jalili, MD TUMS
Tehran University of Medical Sciences
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP