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Completed

NCT Number: NCT01465984

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

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.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

TUMS

Tehran, Tehran Province, 1417613151, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paracetamol

Drug

paracetamol , 1 gram Iv infusion Morphine Sulfate0.1 Mg/Kg Iv

Primary outcomes

  1. Change in pain severity/score

    Time frame: after 30 minutes

Secondary outcomes

  1. Need for rescue analgesia

    Time frame: After 30 minutes

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

Comparison of IV Paracetamol With Intravenous Morphine Sulfate in Treatment of Acute Pain Due to Limb Trauma

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 7, 2011
Registry last updated
Dec 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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