Comparison of Intravenous Ibuprofen and Paracetamol in Patients With Sciatica Presented to the Emergency Department
Keywords
Abstract
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.
Dates
| Last Verified: | 06/30/2016 |
| First Submitted: | 05/16/2016 |
| Estimated Enrollment Submitted: | 05/17/2016 |
| First Posted: | 05/18/2016 |
| Last Update Submitted: | 07/13/2016 |
| Last Update Posted: | 07/14/2016 |
| Actual Study Start Date: | 02/29/2016 |
| Estimated Primary Completion Date: | 07/31/2016 |
| Estimated Study Completion Date: | 08/31/2016 |
Condition or disease
Intervention/treatment
Drug: paracetamol group
Drug: Ibuprofen group
Phase
Arm Groups
| 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 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) |
| Experimental: Ibuprofen group Second Group: 400 mg Ibuprofen in 150 ml normal saline given as a slow intravenous infusion over 5 minutes | Drug: Ibuprofen group 400 mg Ibuprofen in 150 ml normal saline given as a slow intravenous infusion over 5 minutes |
Eligibility Criteria
| Ages Eligible for Study | 21 Years To 21 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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: - 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 |
Outcome
Primary Outcome Measures
1. Reduction of Sciatica pain in Visual Analog Scale İn 30 minutes. [Sciatica pain scores will be recorded at 0, 15, and 30 min.]
Secondary Outcome Measures
1. Adverse events [30 minutes after the drug administered.]
