NCT03603626

Preemptive Pregabalin in Myringoplasty

Effect of Preemptive Pregabalin for Post-operative Pain Relief in Myringoplasty

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Dhulikhel Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to investigate the effect of preemptive pregabalin on post-operative pain reduction after myringoplasty.

Detailed description

Patient were randomly assigned to one of two groups with 30 participants each by lottery method. Pregabalin group received capsule Pregabalin 150mg and Placebo group were given Vitamin B capsule 1 hour prior to surgery. All patients underwent endoscopic myringoplasty with tragal cartilage and perichondrium graft. Surgical procedure was done under local anesthesia. 5ml of 2% xylocaine with 1:2,00,000 adrenalin was infiltrated in the four quadrants of external ear canal and on tragus. Around 2cm incision was given on canal surface of tragus and around 2cm x 1.5cm cartilage- perichondrium graft was obtained. The skin was closed with 4/0 prolene interrupted suture. Using rigid Hopkins II 0-degree endoscope (Karl Storz) with 4-millimeter diameter and 18 centimeters in length, margin of perforation was refreshed. Gelatin sponge was kept in the middle ear and cartilage perichondrium graft placed. Canal was then packed with gelatin soaked in ciprofloxacin ear drops followed by ribbon pack medicated with soframycin. Small dressing was applied over it. Post-operative pain severity was assessed with VAS scale at 6, 12, 24, 48 hours. Rescue analgesia is given with Injection Ketorolac (30mg IV) or Tab Flexon (Ibuprofen 400mg + Paracetamol 500mg) whenever the patient required.

Conditions

• Post-operative Analgesia
• CSOM - Chronic Suppurative Otitis Media

Interventions

Type	Name	Description
DRUG	Pregabalin 150mg	Preemptive pregabalin 150 mg administered 1 hour before surgery
DRUG	Placebo oral capsule	Placebo administered 1 hour before surgery

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2018-07-27
• Last updated: 2018-09-24

Locations

1 site across 1 country: Nepal