IV Paracetamol vs IV Morphine vs Placebo in Sciatalgia in Patients Presented With Sciatalgia to Emergency Department: A Randomized Controlled Trial
Overview
- Phase
- Phase 4
- Sponsor
- Akdeniz University
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Visual Analogue Scale Score to measure pain reduction
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Paracetamol
1 g intravenous paracetamol (Perfalga, Bristol Myers) in 100 ml saline with a rapid infusion.
Intervention: Paracetamol (Drug)
morphine
0.1 mg/kg morphine in 100 ml saline with a rapid infusion.
Intervention: morphine (Drug)
placebo
100 ml saline
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Visual Analogue Scale Score to measure pain reduction
Time Frame: 30 minutes
Visual Analogue Scale Score at 30 minutes in order to measure pain reduction
Secondary Outcomes
- Adverse effects(30 minutes)
- Rescue drug need questionnaire(30 minutes)
Investigators
Cenker Eken
Associate Proffesor
Akdeniz University