SciaticaPhase 4NCT02504996
IV Paracetamol vs IV Morphine vs Placebo in Sciatalgia
A Phase 4 study testing Paracetamol and morphine in people with Sciatica, run by Akdeniz University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Sciatica
- What is being tested?
- Paracetamol and morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2015to Mar 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Pamukkale University Hospital
Denizli
Aysel Özkan, 00902582961758, karek@pau.edu.tr
Mustafa Serinken, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Sciatica
- Being tested
- Paracetamol, morphine, Placebo
- Keywords
- sciatalgia, emergency department, paracetamol, morphine
- Medical subject headings
- Sciatica, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Also called Perfalgan
1 g paracetamol via intravenous route in 100 ml normal saline
morphineDrug
Also called Morfin
0.1 mg/kg morphine via intravenous route in 100 ml normal saline
PlaceboDrug
Intravenous 100 ml normal saline
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol | Active comparator | 1 g intravenous paracetamol (Perfalga, Bristol Myers) in 100 ml saline with a rapid infusion. Receives: Drug: Paracetamol |
| morphine | Active comparator | 0.1 mg/kg morphine in 100 ml saline with a rapid infusion. Receives: Drug: morphine |
| placebo | Placebo comparator | 100 ml saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale Score to measure pain reduction
Visual Analogue Scale Score at 30 minutes in order to measure pain reduction
Measured: 30 minutes
Secondary outcomes (2)
Rescue drug need questionnaire
The rescue drug need will be recorded by asking the study patient at 30 minutes. yes/no
Measured: 30 minutes
Adverse effects
Adverse effects occurred within the 30 minutes period
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SciaticaStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Collaborators
- Pamukkale University, Antalya Training and Research Hospital, University of Gaziantep, Ataturk University
- Responsible party
- Principal investigator, Cenker Eken, Akdeniz University
- Investigators
- Mustafa Serinken, MD, Study chair, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504996
- Sponsor's protocol ID
- 70178
- Status last verified
- Jul 2015
- First submitted
- 2 Jul 2015
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IV Paracetamol vs IV Morphine vs Placebo in Sciatalgia in Patients Presented With Sciatalgia to Emergency Department: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02504996
- Acronym / sponsor ID
- 70178
- Conditions
- Sciatica
- Keywords
- sciatalgia, emergency department, paracetamol, morphine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Collaborators
- Pamukkale University, Antalya Training and Research Hospital, University of Gaziantep, Ataturk University
- Study start
- Jan 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Paracetamol | Active comparator | Drug: Paracetamol1 g intravenous paracetamol (Perfalga, Bristol Myers) in 100 ml saline with a rapid infusion. |
| morphine | Active comparator | Drug: morphine0.1 mg/kg morphine in 100 ml saline with a rapid infusion. |
| placebo | Placebo comparator | Drug: Placebo100 ml saline |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParacetamolAlso: Perfalgan1 g paracetamol via intravenous route in 100 ml normal saline | Drug | Paracetamol |
| morphineAlso: Morfin0.1 mg/kg morphine via intravenous route in 100 ml normal saline | Drug | morphine |
| PlaceboIntravenous 100 ml normal saline | Drug | placebo |
Primary outcome
Visual Analogue Scale Score to measure pain reduction
Time frame: 30 minutes
Visual Analogue Scale Score at 30 minutes in order to measure pain reduction
2 secondary outcomes
Rescue drug need questionnaire
Time frame: 30 minutes
Adverse effects
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mustafa Serinken, MD study chair
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paracetamol and morphine in people with Sciatica, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cenker Eken, MD (00905321593948, cenkereken@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale Score to measure pain reduction (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2015.