IV Paracetamol vs IV Morphine vs Placebo in Sciatalgia

Akdeniz University

Status and phase: Unknown; Phase 4

Conditions: Sciatica

Treatments: Drug: Paracetamol; Drug: Placebo; Drug: morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT02504996

70178

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 3 patient groups, including a placebo group

Paracetamol

Active Comparator group

Description:

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

Treatment:

Drug: Paracetamol

morphine

Active Comparator group

Description:

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

Treatment:

Drug: morphine

placebo

Placebo Comparator group

Description:

100 ml saline

Treatment:

Drug: Placebo