IV Paracetamol vs IV Morphine vs Placebo in Sciatalgia
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 2, 2015
CompletedFirst Posted
Study publicly available on registry
July 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedJuly 22, 2015
July 1, 2015
1.2 years
July 2, 2015
July 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Analogue Scale Score to measure pain reduction
Visual Analogue Scale Score at 30 minutes in order to measure pain reduction
30 minutes
Secondary Outcomes (2)
Rescue drug need questionnaire
30 minutes
Adverse effects
30 minutes
Study Arms (3)
Paracetamol
ACTIVE COMPARATOR1 g intravenous paracetamol (Perfalga, Bristol Myers) in 100 ml saline with a rapid infusion.
morphine
ACTIVE COMPARATOR0.1 mg/kg morphine in 100 ml saline with a rapid infusion.
placebo
PLACEBO COMPARATOR100 ml saline
Interventions
1 g paracetamol via intravenous route in 100 ml normal saline
0.1 mg/kg morphine via intravenous route in 100 ml normal saline
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Akdeniz Universitylead
- Pamukkale Universitycollaborator
- Antalya Training and Research Hospitalcollaborator
- University of Gaziantepcollaborator
- Ataturk Universitycollaborator
Study Sites (1)
Pamukkale University Hospital
Denizli, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mustafa Serinken, MD
Pamukkale University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Proffesor
Study Record Dates
First Submitted
July 2, 2015
First Posted
July 22, 2015
Study Start
January 1, 2015
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
July 22, 2015
Record last verified: 2015-07