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

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01465984
• Other study ID #: ACET1390
• Secondary ID: TUMS Thesis 1389
• Status: Completed
• Phase: Phase 4
• First received: November 2, 2011
• Last updated: December 6, 2012
• Start date: November 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• Paracetamol
paracetamol , 1 gram Iv infusion Morphine Sulfate0.1 Mg/Kg Iv

Locations

Country	Name	City	State
Iran, Islamic Republic of	TUMS	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain severity/score		after 30 minutes	No
Secondary	Need for rescue analgesia		After 30 minutes	Yes