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

Phase 4

Completed

• Conditions: Acute Pain
• Interventions: Drug: Paracetamol

• Registration Number: NCT01465984
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-02
• Study First Submitted QC: 2011-11-04
• Study First Posted: 2011-11-06
• Primary Completion: 2012-09
• Status Verified: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-06
• Last Update Posted: 2012-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV Paracetamol	Paracetamol	-
IV Morphine Sulfate	Paracetamol	-

Primary Outcome Measures

Name	Time	Method
Change in pain severity/score	after 30 minutes

Secondary Outcome Measures

Name	Time	Method
Need for rescue analgesia	After 30 minutes

Trial Locations

Locations (1)

TUMS; 🇮🇷 Tehran, Iran, Islamic Republic of