IV Paracetamol vs IV Morphine vs Placebo in Sciatalgia

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

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.

Study Overview

• Status: Unknown
• Conditions: Sciatica
• Intervention / Treatment: Drug: Paracetamol; Drug: morphine; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Denizli, Turkey
    • Recruiting
    • Pamukkale University Hospital
    • Principal Investigator: Mustafa Serinken, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Akdeniz University
• Collaborators: Pamukkale University; Ataturk University; Antalya Training and Research Hospital; University of Gaziantep

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: July 2, 2015
• First Submitted That Met QC Criteria: July 21, 2015
• First Posted (Estimate): July 22, 2015

Study Record Updates

• Last Update Posted (Estimate): July 22, 2015
• Last Update Submitted That Met QC Criteria: July 21, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: morphine; emergency department; paracetamol; sciatalgia
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuralgia; Sciatica; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Analgesics, Opioid; Narcotics; Acetaminophen; Morphine
• Other Study ID Numbers: 70178