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Status unknownNCT02777320Updated Jul 15, 2016

Comparison of Intravenous Ibuprofen and Paracetamol in Patients With Sciatica Presented to the Emergency Department

A Phase 4 interventional study of paracetamol and Ibuprofen in Sciatica, sponsored by Pamukkale University. Status unknown at 1 site in Turkey. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-07-15.

Sponsored by Pamukkale University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
01

Study summary

Currently, Paracetamol and Ibuprofen are widely used by emergency physicians in Turkey for the pain treatments.

The objective of the study was to assess whether intravenous Paracetamol has superior Sciatica pain reduction will compare with Ibuprofen in emergency department (ED) adults.

Half of the participants will receive Paracetamol and the other half will receive Ibuprofen.

Read the detailed description

Paracetamol and Ibuprofen each relieve pain witf different mechanisms.

Paracetamol is termed a simple analgesic and an antipyretic. Despite enduring assertions that it acts by inhibition of cyclooxygenase (COX)-mediated production of prostaglandins, unlike non-steroidal anti-inflammatory drugs (NSAIDs).

Ibuprofen is the most commonly used and most frequently prescribed NSAID. It is a non-selective inhibitor of cyclo-oxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2).4 Although its anti inflammatory properties may be weaker than those of some other NSAIDs, it has a prominent analgesic and antipyretic role.

In our trial; The investigators aimed to compare intravenous Paracetamol and Ibuprofen in patient with Sciatica

  • All patients eligible for the study(Approximately 200 patient with sciatica) were randomized to one of two groups:
  • First Group: 1000 mg Paracetamol in 150 ml normal saline given as a slow intravenous infusion over 5 minutes.
  • 100 ml of saline is removed before the addition of the 100 ml paracetamol to be the same volume.
  • Second Group: 400 mg Ibuprofen in 150 ml normal saline given as a slow intravenous infusion over 5 minutes.
  • Drug packs were prepared according to the computer-generated random number sequence to assign treatment allocations
  • The allocation list was kept by the emergency nurse. Patients received the paracetamol or Ibuprofen medication schemes according to their random allocations.
  • After enrollment and recording of baseline information, the next numbered study drug pack was obtained, and administered as a infusion over 5 minutes.
  • Randomization was achieved by using computer software to generate random numbers.
  • One researcher blinded to patient allocation observed the whole procedure and recorded the Sciatica pain scores.
  • Patients in both groups received two types of medication in a similar manner (for example, 150 ml normal saline given as a slow intravenous infusion over 5 minutes), thus ensuring double blinding.
  • Sciatica pain scores were recorded at 0, 15, and 30 min on a VAS of 1 to 10
  • Rescue medication is given patients If the clinician think it's necessary within 30 minutes after study drug administration.
  • All other medications required during the study also were recorded.
02

Conditions studied

  • Sciatica

Keywords

  • Sciatica
  • Ibuprofen
  • Paracetamol
  • Emergency Medicine
03

In context

Sciatica

139 studies on the registry are indexed under Sciatica; 29 are open to participants now.

This study's planned enrollment of 120 is above the median of 66 across 111 interventional studies indexed under Sciatica.

Browse Sciatica studies →

Lead sponsor

Pamukkale University is the lead sponsor of 331 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients who presented with complaints of leg pain radiating the sciatic nerve tracings to the emergency services (Which may or may not be accompanied back pain),
  • Positive Laseque test identified patients in physical examination,
  • Patients whose complaints have started in the last week,
  • Younger than 21 years old,
  • Older than 65 years old.

Exclusion criteria

Exclusion Criteria:

  • Patients who have a leg or low back pain longer than a week Have a direct blunt trauma to the legs or lumbar area in the last week,
  • Pretreatment linear 100-mm visual analog scale (VAS) pain score less than 40 mm,
  • Patients who have drop foot, paralysis and other neurological symptoms in physical examination.
  • Patients with blood pressure less than 90mmHg in the arrival of emergency services.
  • Patients with malignancy, cauda equina syndrome, ankylosing spondylitis, rheumatoid arthritis or inflammatory arthritis contain any of the disease in his/her CV.
  • Patients with any history of chronic pain syndrome.
  • Patients who receive pain killers, antidepressants, anticonvulsants, muscle relaxants, steroids within 6 hours before the ED visit,
  • Patients with a history of Substance Dependence or alcohol abuse
  • Patients had a fever (>37.9)
  • Allergy or previous adverse reaction to the studied drugs(Ibuprofen, Paracetamol), received agents to inhibit the secretion of acid (PPIs or histamine-2 receptor antagonists), antispasmodics, or nonsteroidal anti-inflammatory drugs
  • were pregnant or breast-feeding,
  • inability to comprehend the VAS evaluation,
  • or refused to participate in the study
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    paracetamol group

    First Group: 1000 mg Paracetamol in 150 ml normal saline given as a slow intravenous infusion over 5 minutes. (100 ml of saline is removed before the addition of the 100 ml paracetamol to be the same volume)

    Drug: paracetamol

  • Experimental
    Ibuprofen group

    Second Group: 400 mg Ibuprofen in 150 ml normal saline given as a slow intravenous infusion over 5 minutes

    Drug: Ibuprofen

Interventions

  • Drugparacetamol

    1000 mg Paracetamol in 150 ml normal saline given as a slow intravenous infusion over 5 minutes (100 ml of saline is removed before the addition of the 100 ml paracetamol to be the same volume)

    Also known as: Perfalgan, Partemol, Parol

  • DrugIbuprofen

    400 mg Ibuprofen in 150 ml normal saline given as a slow intravenous infusion over 5 minutes

    Also known as: Intrafen, Caldolon

06

What researchers measure

Primary outcomes

  1. Reduction of Sciatica pain in Visual Analog Scale İn 30 minutes.

    this work tooks 6 mounts

    Time frame: Sciatica pain scores will be recorded at 0, 15, and 30 min.

Secondary outcomes

  1. Adverse events

    30 minutes after the study drug administered

    Time frame: 30 minutes after the drug administered.

07

Study locations

1 of 1 sites recruiting
  • Pamukkale University
    Denizli, 20070, Turkey
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02777320
Lead sponsor
Pamukkale University
Responsible party
Mustafa Serinken (professor, Pamukkale University) — Principal investigator
First posted
May 19, 2016
Start date
Mar 2016
Primary completion
Aug 2016 (estimated)
Completion
Sep 2016 (estimated)
Last update
Jul 15, 2016

Study contacts

Mustafa SERINKEN, professor
Contact
aserinken@hotmail.com
+905052991497
Hayri ELICABUK, MD
Contact
hayrielicabuk@hotmail.com
+905385079500
Mustafa SERINKEN, professor
study director · Pamukkale University
Cenker EKEN, associate professor
study director · Akdeniz University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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