IV Paracetamol vs IV Morphine vs Placebo in Sciatalgia

Sciatica Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02504996
• Other study ID #: 70178
• Status: Recruiting
• Phase: Phase 4
• First received: July 2, 2015
• Last updated: July 21, 2015
• Start date: January 2015
• Est. completion date: March 2016

Study information

• Verified date: July 2015
• Source: Akdeniz University
• Contact: Cenker Eken, MD
• Phone: 00905321593948
• Email: cenkereken[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Drug and Medical Device Institution
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sciatica

Intervention

Drug:
• Paracetamol
1 g paracetamol via intravenous route in 100 ml normal saline
• morphine
0.1 mg/kg morphine via intravenous route in 100 ml normal saline
• Placebo
Intravenous 100 ml normal saline

Locations

Country	Name	City	State
Turkey	Pamukkale University Hospital	Denizli

Sponsors (5)

Lead Sponsor	Collaborator
Akdeniz University	Antalya Training and Research Hospital, Ataturk University, Pamukkale University, University of Gaziantep

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale Score to measure pain reduction	Visual Analogue Scale Score at 30 minutes in order to measure pain reduction	30 minutes	No
Secondary	Rescue drug need questionnaire	The rescue drug need will be recorded by asking the study patient at 30 minutes. yes/no	30 minutes	No
Secondary	Adverse effects	Adverse effects occurred within the 30 minutes period	30 minutes	Yes