Comparison of Intravenous Ibuprofen and Paracetamol in Patients With Sciatica Presented to the Emergency Department
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|ClinicalTrials.gov Identifier: NCT02777320|
Recruitment Status : Unknown
Verified July 2016 by Mustafa Serinken, Pamukkale University.
Recruitment status was: Recruiting
First Posted : May 19, 2016
Last Update Posted : July 15, 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 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.
|Condition or disease||Intervention/treatment||Phase|
|Sciatica||Drug: paracetamol Drug: Ibuprofen||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Comparison of Intravenous Ibuprofen and Paracetamol in Patients With Sciatica Presented to the Emergency Department: A Randomized, Double-Blind, Controlled Trial.|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||September 2016|
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 (100 ml of saline is removed before the addition of the 100 ml paracetamol to be the same volume)
Experimental: Ibuprofen group
Second Group: 400 mg Ibuprofen in 150 ml normal saline given as a slow intravenous infusion over 5 minutes
400 mg Ibuprofen in 150 ml normal saline given as a slow intravenous infusion over 5 minutes
- Reduction of Sciatica pain in Visual Analog Scale İn 30 minutes. [ Time Frame: Sciatica pain scores will be recorded at 0, 15, and 30 min. ]this work tooks 6 mounts
- Adverse events [ Time Frame: 30 minutes after the drug administered. ]30 minutes after the study drug administered
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02777320
|Contact: Mustafa SERINKEN, email@example.com|
|Contact: Hayri ELICABUK, MDfirstname.lastname@example.org|
|Denizli, Turkey, 20070|
|Contact: Mustafa SERINKEN, Professor +905052991497 email@example.com|
|Contact: Hayri ELİÇABUK, MD +905385079500 firstname.lastname@example.org|
|Principal Investigator: Cenker Eken, associate professor|
|Study Director:||Mustafa SERINKEN, professor||Pamukkale University|
|Study Director:||Cenker EKEN, associate professor||Akdeniz University|