Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-24 @ 3:37 PM
Study NCT ID:
NCT03482492
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2018-03-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tramadol vs.Tramadol With Paracetamol
Sponsor:
Yeditepe University Hospital
Organization:
Study Overview
Official Title:
Comparison of Tramadol vs. Tramadol With Paracetamol for Efficacy of Postoperative Pain Management in Lumbar Discectomy: A Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study focused on to determine postoperative analgesic efficacy of tramadol compared to tramadol with addition of paracetamol after a lumbar disc surgery.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: