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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02504996
Enrollment
300
Registered
2015-07-22
Start date
2015-01-31
Completion date
2016-03-31
Last updated
2015-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sciatica

Keywords

sciatalgia, emergency department, paracetamol, morphine

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.

Interventions

DRUGParacetamol

1 g paracetamol via intravenous route in 100 ml normal saline

DRUGmorphine

0.1 mg/kg morphine via intravenous route in 100 ml normal saline

DRUGPlacebo

Intravenous 100 ml normal saline

Sponsors

Pamukkale University
CollaboratorOTHER
Antalya Training and Research Hospital
CollaboratorOTHER_GOV
University of Gaziantep
CollaboratorOTHER
Ataturk University
CollaboratorOTHER
Akdeniz University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual Analogue Scale Score to measure pain reduction30 minutesVisual Analogue Scale Score at 30 minutes in order to measure pain reduction

Secondary

MeasureTime frameDescription
Rescue drug need questionnaire30 minutesThe rescue drug need will be recorded by asking the study patient at 30 minutes. yes/no
Adverse effects30 minutesAdverse effects occurred within the 30 minutes period

Countries

Turkey (Türkiye)

Contacts

Primary ContactCenker Eken, MD
cenkereken@gmail.com00905321593948
Backup ContactMustafa Serinken, MD
aserinken@hotmail.com00905052991497

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026