IV Paracetamol vs IV Morphine vs Placebo in Sciatalgia

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
IV Paracetamol vs IV Morphine vs Placebo in Sciatalgia in Patients Presented With Sciatalgia to Emergency Department: A Randomized Controlled Trial

Conditions
-----------------
Sciatica

Intervention / Treatment
-----------------
* Drug: Paracetamol
* Drug: morphine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paracetamol<br>1 g intravenous paracetamol (Perfalga, Bristol Myers) in 100 ml saline with a rapid infusion. | Drug: Paracetamol<br>* 1 g paracetamol via intravenous route in 100 ml normal saline<br>* Other names: Perfalgan;|
| Active Comparator: morphine<br>0.1 mg/kg morphine in 100 ml saline with a rapid infusion. | Drug: morphine<br>* 0.1 mg/kg morphine via intravenous route in 100 ml normal saline<br>* Other names: Morfin;|
| Placebo Comparator: placebo<br>100 ml saline | Drug: Placebo<br>* Intravenous 100 ml normal saline<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale Score to measure pain reduction | Visual Analogue Scale Score at 30 minutes in order to measure pain reduction | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rescue drug need questionnaire | The rescue drug need will be recorded by asking the study patient at 30 minutes. yes/no | 30 minutes | 
| Adverse effects | Adverse effects occurred within the 30 minutes period | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
paracetamol, sciatalgia, emergency department, morphine