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

• ClinicalTrials.gov Identifier: NCT02836509
• Recruitment Status: Unknown
• First Posted: July 19, 2016
• Last Update Posted: July 19, 2016
• Sponsor: Pamukkale University
• Information provided by (Responsible Party): Mustafa Serinken, Pamukkale University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Low Back Pain	Drug: Paracetamol; Drug: Ibuprofen	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Comparison of Intravenous Ibuprofen and Paracetamol in Patients With Low Back Pain Presented to the Emergency Department: A Randomized, Double-Blind, Controlled Trial
• Study Start Date: September 2016
• Estimated Primary Completion Date: December 2016
• Estimated Study Completion Date: March 2017

Arms and Interventions

Arm	Intervention/treatment
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; 1000 mg Paracetamol in 150 ml normal saline given as a slow intravenous infusion over 5 minutes.; Other Names: PERFALGAN; PARTEMOL; PAROL
Experimental: Ibuprofen group; Second Group: 800 mg Ibuprofen in 150 ml normal saline given as a slow intravenous infusion over 5 minutes	Drug: Ibuprofen; 800 mg Ibuprofen in 150 ml normal saline given as a slow intravenous infusion over 5 minutes; Other Names: intrafen; Caldolon

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

1. Adverse events [ Time Frame: 30th minutes after the study drug administered ]
   30th minutes after the study drug administered

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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:

• 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

Contacts and Locations

Contacts

Contact: Mustafa SERINKEN, professor; 505 2991497; aserinken@hotmail.com

Contact: hayri eliçabuk, medical Doctor; 5385079500; hayrielicabuk@hotmail.com

Sponsors and Collaborators

Pamukkale University

More Information

• Responsible Party: Mustafa Serinken, professor, Pamukkale University
• ClinicalTrials.gov Identifier: NCT02836509
• Other Study ID Numbers: LBPainIvsP
• First Posted: July 19, 2016
• Last Update Posted: July 19, 2016
• Last Verified: July 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Mustafa Serinken, Pamukkale University:

Low Back Pain; Ibuprofen; Paracetamol; Emergency Medicine

Additional relevant MeSH terms:

Back Pain; Emergencies; Low Back Pain; Pain; Neurologic Manifestations; Disease Attributes; Pathologic Processes; Acetaminophen; Ibuprofen; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antipyretics