Tramadol vs.Tramadol With Paracetamol
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|ClinicalTrials.gov Identifier: NCT03482492|
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : March 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lumbar Disc Herniation||Drug: Tramadol Drug: Paracetamol||Not Applicable|
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.
This study focused on to determine postoperative analgesic efficacy of tramadol compared to tramadol with addition of paracetamol after a lumbar disc surgery.
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Tramadol vs. Tramadol With Paracetamol for Efficacy of Postoperative Pain Management in Lumbar Discectomy: A Randomised Controlled Trial|
|Actual Study Start Date :||March 20, 2014|
|Actual Primary Completion Date :||January 12, 2015|
|Actual Study Completion Date :||April 3, 2015|
Active Comparator: Tramadol
Group Tramadol patients received tramadol 1 mg kg-1 iv
Active Comparator: Tramadol-Paracetamol
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
- Severity of pain [ Time Frame: 2 hours ]Self reported pain intensity
- Tramadol consumption [ Time Frame: 2 hours ]Total tramadol consumption during time frame
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): NCT03482492
|Principal Investigator:||Neslihan Uztüre, MD||Yeditepe University|