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Perioperative Administration of Pregabalin for Pain After Septoplasty

Information source: Samsung Medical Center
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Deviated Nasal Septum

Intervention: Pregabalin (Lyrica) (Drug); Vitamin complex (placebo) (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Samsung Medical Center

Official(s) and/or principal investigator(s):
Hun Jong Dhong, MD, PhD, Principal Investigator, Affiliation: Samsung Medical Center, Department of Otorhinolaryngoloty

Summary

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.

Clinical Details

Official title: Perioperative Administration of Pregabalin for Pain After Septoplasty

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Primary outcome: Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS)

Secondary outcome:

The number of patients with side effects including Nausea and vomiting, sedation, headache, dizziness

The number of patients who required additional analgesics during admission

Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS)

Detailed description: 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.

Eligibility

Minimum age: 20 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age 20 ≥ and ≤ 65 years

- Patients with nasal packing after septoplasty

Exclusion Criteria:

- previous septal surgery history

- postoperative complications including septal hematoma, bleeding ets.

- Current therapy with pregabalin, gabapentin, or any opioid

- Renal insufficiency

- History of seizure disorder

Locations and Contacts

Department of Otorhinolaryngology H&N surgery, Sungkyunkwan University College of Medicine, Samsung Seoul Hospital, Seoul 135-710, Korea, Republic of; Recruiting
JOON HO KIM, Phone: 82-2-3410-3579, Email: juno0077.kim@samsung.com
Additional Information

Starting date: September 2010
Last updated: June 9, 2011

Page last updated: February 07, 2013

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