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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01465984
First received: November 2, 2011
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention Phase
Acute Pain
 Drug: Paracetamol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Injuries Wounds
U.S. FDA Resources

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Change in pain severity/score [ Time Frame: after 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Need for rescue analgesia [ Time Frame: After 30 minutes ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: November 2011
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465984

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

No publications provided

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01465984     History of Changes
Other Study ID Numbers: ACET1390, TUMS Thesis 1389
Study First Received: November 2, 2011
Last Updated: December 6, 2012
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

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

Additional relevant MeSH terms:
Acetaminophen
Morphine
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on May 16, 2013