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

NCT ID: NCT01465984

Last Updated: 2012-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-12-31

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.

Conditions

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Acute Pain

Keywords

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Paracetamol Morphine sulfates Acute pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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IV Paracetamol

Group Type EXPERIMENTAL

Paracetamol

Intervention Type DRUG

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

IV Morphine Sulfate

Group Type ACTIVE_COMPARATOR

Paracetamol

Intervention Type DRUG

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

Interventions

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Paracetamol

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

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohammad Jalili, MD

Role: STUDY_DIRECTOR

TUMS

Locations

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TUMS

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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TUMS Thesis 1389

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ACET1390

Identifier Type: -

Identifier Source: org_study_id