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Pregabalin is used for the treatment of neuropathic pain and has shown analgesic efficacy in postoperative pain. The aim of this randomized, double-blinded, placebo-controlled trial was to investigate the efficacy and safety of pregabalin for reducing postoperative pain in patients after septoplasty. Persons who scheduled for elective septoplasty under general anesthesia were randomly assigned to groups that received either pregabalin (150 mg twice) or placebo, one hour before surgery and 12 hours after the initial dose. Assessments of pain (verbal numerical rating scale) and side effects were performed at one, six, 12, and 24 hours postoperatively.
Pregabalin is used for the treatment of neuropathic pain and has shown analgesic efficacy in postoperative pain. The aim of this randomized, double-blinded, placebo-controlled trial was to investigate the efficacy and safety of pregabalin for reducing postoperative pain in patients after septoplasty. Patients will be randomly assigned to one of two groups to receive either pregabalin (Lyrica®, Pfizer, Inc.) or placebo (vitamin complex). According to their assigned study group, patients received either pregabalin (75 mg) or placebo twice, one hour before surgery and 12 hours after the initial dose. The assessment of pain and side effects, such as nausea and vomiting, headache, dizziness, sedation, and blurred vision, were made at one, six, 12, and 24 hours postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin | Experimental | Patients receive oral placebo 150 mg 1hour prior to septal surgery, and 12 hours later |
|
| Placebo | Placebo Comparator | Patients receive oral Placebo(Vitamin complex) 150 mg 1 hour before septal surgery, and 12 hours later |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin (Lyrica) | Drug | Patients receive oral Pregabalin 150 mg 1 hour before septal surgery, and 12 hours later |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS) | postoperative 24 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| The number of patients with side effects including Nausea and vomiting, sedation, headache, dizziness | postoperative 1, 6, 12, 24 hours | |
| The number of patients who required additional analgesics during admission | postoperative 1,6,12,24 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hun Jong Dhong, MD, PhD | Samsung Medical Center, Department of Otorhinolaryngoloty | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Otorhinolaryngology H&N surgery, Sungkyunkwan University College of Medicine, Samsung Seoul Hospital | Recruiting | Seoul | 135-710 | South Korea |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Vitamin complex (placebo) | Drug | Patients receive oral Placebo(Vitamin complex) 150 mg 1 hour before septal surgery, and 12 hours later |
|
|
| Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS) | postoperative 1, 6, 12 hours |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |