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Status unknownNCT02836509Updated Jul 19, 2016

Comparison of Intravenous Ibuprofen and Paracetamol in Patients With Low Back Pain Presented to the Emergency Department

A Phase 4 interventional study of Paracetamol and Ibuprofen in Low Back Pain, sponsored by Pamukkale University. Status unknown. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-07-19.

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verified this record recently (last verified Jul 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
21 Years to 80 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 Low Back 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 with 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 the investigators trial; The investigators aimed to compare intravenous Paracetamol and Ibuprofen in patient with Low Back Pain

  • All patients eligible for the study 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 (Perfalgan, Bristol Myers, Italy) to be the same volume.
  • Second Group: 800mg Ibuprofen (Intrafen Flk, Gen drug, Turkey) 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 Low Back 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.
  • Low Back Pain scores were recorded at 0, 15, and 30 min on a VAS of 1 to 10
  • Rescue medication is given within 30 minutes after study drug administration if the patients say yes that question "Do you need any additional analgesic requirement".
  • All other medications required during the study also were recorded.
02

Conditions studied

  • Low Back Pain

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Keywords

  • Low Back Pain
  • Ibuprofen
  • Paracetamol
  • Emergency Medicine
03

In context

Low Back Pain

2,875 studies on the registry are indexed under Low Back Pain; 484 are open to participants now.

This study's planned enrollment of 200 is above the median of 60 across 2,315 interventional studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

Pamukkale University is the lead sponsor of 340 studies on the registry; 62 are open to participants now.

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

04

Who can participate

Ages eligible
21 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients who presented with complaints of low back pain to the emergency services ,
  • Patients whose complaints have started in the last week,
  • Younger than 21 years old,
  • older than 80 years old,

Exclusion criteria

Exclusion Criteria:

  • 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 have a history of active peptic ulcer disease,
  • Patients who have signs of peritoneal irritation,
  • 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
200 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: 800 mg Ibuprofen in 150 ml normal saline given as a slow intravenous infusion over 5 minutes

    Drug: Ibuprofen

Interventions

  • 1000 mg Paracetamol in 150 ml normal saline given as a slow intravenous infusion over 5 minutes.

    Also known as: PERFALGAN, PARTEMOL, PAROL

  • 800 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 Low Back Pain on the Visual Analog Scale

    Time frame: Low Back Pain scores will be recorded at 0, 15, and 30 min on a VAS of 1 to 10

Secondary outcomes

  1. Adverse events

    30th minutes after the study drug administered

    Time frame: 30th minutes after the study drug administered

07

Study locations

No study locations are listed for this record.

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 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02836509
Responsible party
Mustafa Serinken (professor, Pamukkale University) — Principal investigator
First posted
Jul 19, 2016
Start date
Sep 2016
Primary completion
Dec 2016 (estimated)
Completion
Mar 2017 (estimated)
Last update
Jul 19, 2016

Study contacts

Mustafa SERINKEN, professor
Contact
aserinken@hotmail.com
505 2991497
hayri eliçabuk, medical Doctor
Contact
hayrielicabuk@hotmail.com
5385079500

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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Studies of the drugs tested here: Acetaminophen · Ibuprofen

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