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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02777320
Other study ID # Sciatica-IvsP
Secondary ID
Status Recruiting
Phase Phase 4
First received May 17, 2016
Last updated July 14, 2016
Start date March 2016
Est. completion date September 2016

Study information

Verified date July 2016
Source Pamukkale University
Contact Mustafa SERINKEN, professor
Phone +905052991497
Email aserinken@hotmail.com
Is FDA regulated No
Health authority Turkey: Drug and Medical Device Institution
Study type Interventional

Clinical Trial 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date September 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Both
Age group 21 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
paracetamol
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)
Ibuprofen
400 mg Ibuprofen in 150 ml normal saline given as a slow intravenous infusion over 5 minutes

Locations

Country Name City State
Turkey Pamukkale University Denizli

Sponsors (1)

Lead Sponsor Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction of Sciatica pain in Visual Analog Scale In 30 minutes. this work tooks 6 mounts Sciatica pain scores will be recorded at 0, 15, and 30 min. No
Secondary Adverse events 30 minutes after the study drug administered 30 minutes after the drug administered. No
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