Preemptive Pregabalin in Myringoplasty

Dhulikhel Hospital

Status: Withdrawn

Conditions: CSOM - Chronic Suppurative Otitis Media; Post-operative Analgesia

Treatments: Drug: Pregabalin 150mg; Drug: Placebo oral capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT03603626

13/18

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

Preemptive pregabalin

Experimental group

Treatment:

Drug: Pregabalin 150mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo oral capsule