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Tramadol vs.Tramadol With Paracetamol

Y

Yeditepe University Hospital

Status

Completed

Conditions

Lumbar Disc Herniation

Treatments

Drug: Paracetamol
Drug: Tramadol

Study type

Interventional

Funder types

Other

Identifiers

NCT03482492
11.03.2014-397

Details and patient eligibility

About

This study focused on to determine postoperative analgesic efficacy of tramadol compared to tramadol with addition of paracetamol after a lumbar disc surgery.

Full description

Background:

Despite developments in treatment of pain, the availability of new drugs or increased knowledge of pain management, postoperative pain control after different surgeries still remains inadequate.

Aims:

This study focused on to determine postoperative analgesic efficacy of tramadol compared to tramadol with addition of paracetamol after a lumbar disc surgery.

Study Design:

In this study we have randomized 60 patients into two treatment groups. In Group Tramadol patients received tramadol, In Group TramadolParacetamol patients received paracetamol 1 gr iv in addition to tramadol 30 minutes before the operation ends and 1 g at 6 hour intervals.

Methods:

Severity of the pain, total tramadol consumption, adverse effects, ramsay sedation scale score, nausea/vomiting scores, patient satisfaction score were recorded in the postoperative period.

Enrollment

60 patients

Sex

All

Ages

30 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

American Society of Anesthesiologists (ASA) 1 or 2 status patients with single level lumbar disc herniation.

Exclusion criteria

Patients who could not use a patient controlled analgesia (PCA) device, known allergies to any of the drugs used in this study,hepatic and renal dysfunction, herniated disc with neurological deficit or intense pain justifying emergency surgery and the patients whose body mass index is ≥30 kg/m2 were excluded from the study.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Tramadol
Active Comparator group
Description:
Group Tramadol patients received tramadol 1 mg kg-1 iv
Treatment:
Drug: Tramadol
Tramadol-Paracetamol
Active Comparator group
Description:
Group Tramadol-Paracetamol patients received paracetamol 1 gr iv in addition to tramadol 1 mg kg-1 iv 30 minutes before the end of the operation and after the operation at 6 hour intervals for 24 hours
Treatment:
Drug: Tramadol
Drug: Paracetamol

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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