Comparison of Intravenous Ibuprofen and Paracetamol in Patients With Low Back Pain Presented to the Emergency Department
|ClinicalTrials.gov Identifier: NCT02836509|
Recruitment Status : Unknown
Verified July 2016 by Mustafa Serinken, Pamukkale University.
Recruitment status was: Not yet recruiting
First Posted : July 19, 2016
Last Update Posted : July 19, 2016
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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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)
1000 mg Paracetamol in 150 ml normal saline given as a slow intravenous infusion over 5 minutes.
Experimental: Ibuprofen group
Second Group: 800 mg Ibuprofen in 150 ml normal saline given as a slow intravenous infusion over 5 minutes
800 mg Ibuprofen in 150 ml normal saline given as a slow intravenous infusion over 5 minutes
- 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 ]
- Adverse events [ Time Frame: 30th minutes after the study drug administered ]30th minutes after the study drug administered
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836509
|Contact: Mustafa SERINKEN, professor||505 firstname.lastname@example.org|
|Contact: hayri eliçabuk, medical Doctoremail@example.com|