IV Paracetamol vs IV Morphine vs Placebo in Sciatalgia

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-03-31

Brief Summary

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Siatalgia is one of the main symptoms related to emergency department presentations. Patients with sciatalgia are seeking for immediate pain relief and little known regarding the pain management of these patients in emergency department. This study aim to trial the effect of intravenous paracetamol and morphine in patients presented with sciatalgia to emergency department.

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Detailed Description

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Siatalgia is one of the main symptoms related to emergency department presentations. Patients with sciatalgia are seeking for immediate pain relief and little known regarding the pain management of these patients in emergency department. Neuronal compression is the main cause of pain in sciatalgia rather than inflammation which also differ sciatalgia from the other type of pains in emergency department. Sciatalgia is a kind of neuralgia and there is not so much option in the pain management of these patients. Intravenous paracetamol and morphine is commonly used analgesics in various kind of pain in emergency department. So, this study aim to trial the effect of intravenous paracetamol and morphine in patients presented with sciatalgia to emergency department.

Conditions

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Sciatica

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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Paracetamol

1 g intravenous paracetamol (Perfalga, Bristol Myers) in 100 ml saline with a rapid infusion.

Group Type ACTIVE_COMPARATOR

Paracetamol

Intervention Type DRUG

1 g paracetamol via intravenous route in 100 ml normal saline

morphine

0.1 mg/kg morphine in 100 ml saline with a rapid infusion.

Group Type ACTIVE_COMPARATOR

morphine

Intervention Type DRUG

0.1 mg/kg morphine via intravenous route in 100 ml normal saline

placebo

100 ml saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intravenous 100 ml normal saline

Interventions

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Paracetamol

1 g paracetamol via intravenous route in 100 ml normal saline

Intervention Type DRUG

morphine

0.1 mg/kg morphine via intravenous route in 100 ml normal saline

Intervention Type DRUG

Placebo

Intravenous 100 ml normal saline

Intervention Type DRUG

Other Intervention Names

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Perfalgan Morfin

Eligibility Criteria

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Inclusion Criteria

* Patients with pain radiating to the sciatic nerve path
* Pain within the last one week
* Patients with positive straight leg raise
* Patients over 21 and lower than 65 years old

Exclusion Criteria

* Pain score lower than 40 mm in visual analogue scale score
* Neurological deficit
* Allergy to the study drugs
* Unstable vital signs
* History of malignancy or rheumatological diseases or arthritis
* History of chronic pain syndrome
* Receiving pain killer, steroid, anti-depressant, anti-convulsant and musculorelaxant within the last six hours.
* Drug or alcohol addiction
* Pregnancy or breast feeding
* Fewer more than 37.9 Celsius degrees.

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No