Preemptive Pregabalin in Myringoplasty

Not Applicable

Withdrawn

• Conditions: CSOM - Chronic Suppurative Otitis Media; Post-operative Analgesia
• Interventions: Drug: Pregabalin 150mg; Drug: Placebo oral capsule

• Registration Number: NCT03603626
• Lead Sponsor: Dhulikhel Hospital

Brief 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.

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Study First Submitted: 2018-07-07
• Study First Submitted QC: 2018-07-26
• Study First Posted: 2018-07-27
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-21
• Last Update Posted: 2018-09-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Cases of Chronic suppurative otitis media (CSOM) inactive planned for endoscopic myringoplasty under local anesthesia,
• Age >= 18 years
• either sex.

Exclusion Criteria

• Revision cases,
• Pregnancy or breastfeeding,
• Known or suspected sensitivity or contraindication to pregabalin,
• Patient using medication for chronic pain,
• History of seizure disorder,
• Mental retardation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preemptive pregabalin	Pregabalin 150mg	-
Placebo	Placebo oral capsule	-

Primary Outcome Measures

Name	Time	Method
This study is constructed to determine whether the use of preemptive single dose oral pregabalin would decrease post-operative pain in patient undergoing myringoplasty.	At 6, 12, 24, 48 hours in postoperative period	Post-operative pain severity was assessed with Visual Analogue Scale (VAS). It's a 10cm scale in which 0 represents no pain at all and 10 represents the worst pain imaginable. VAS score was compared between 2 groups at 6, 12, 24, 48 hrs post-operative period. This would show if there is any change in pain score between groups using pregabalin or placebo in the given time frame.

Trial Locations

Locations (1)

Dhulikhel Hospital; 🇳🇵 Dhulikhel, Kavre, Nepal