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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Pain

Intervention / Treatment
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* Drug: Paracetamol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV Paracetamol<br> | Drug: Paracetamol<br>* paracetamol , 1 gram Iv infusion Morphine Sulfate0.1 Mg/Kg Iv<br>|
| Active Comparator: IV Morphine Sulfate<br> | Drug: Paracetamol<br>* paracetamol , 1 gram Iv infusion Morphine Sulfate0.1 Mg/Kg Iv<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain severity/score |  | after 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for rescue analgesia |  | After 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paracetamol, Morphine sulfates, Acute pain