IV Paracetamol vs IV Morphine vs Placebo in Sciatalgia

Phase 4

• Conditions: Sciatica
• Interventions: Drug: Paracetamol; Drug: morphine; Drug: Placebo

• Registration Number: NCT02504996
• Lead Sponsor: Akdeniz University

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 Timeline

• Study Start: 2015-01
• Status Verified: 2015-07
• Study First Submitted: 2015-07-02
• Study First Submitted QC: 2015-07-21
• Last Update Submitted: 2015-07-21
• Study First Posted: 2015-07-22
• Last Update Posted: 2015-07-22
• Primary Completion: 2016-03
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paracetamol	Paracetamol	1 g intravenous paracetamol (Perfalga, Bristol Myers) in 100 ml saline with a rapid infusion.
morphine	morphine	0.1 mg/kg morphine in 100 ml saline with a rapid infusion.
placebo	Placebo	100 ml saline

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale Score to measure pain reduction	30 minutes	Visual Analogue Scale Score at 30 minutes in order to measure pain reduction

Secondary Outcome Measures

Name	Time	Method
Adverse effects	30 minutes	Adverse effects occurred within the 30 minutes period
Rescue drug need questionnaire	30 minutes	The rescue drug need will be recorded by asking the study patient at 30 minutes. yes/no

Trial Locations

Locations (1)

Pamukkale University Hospital; 🇹🇷 Denizli, Turkey