Preemptive Pregabalin in Myringoplasty

NCT ID: NCT03603626

Last Updated: 2018-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-12-31

Brief Summary

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

Detailed Description

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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

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Post-operative Analgesia CSOM - Chronic Suppurative Otitis Media

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Preemptive pregabalin

Group Type EXPERIMENTAL

Pregabalin 150mg

Intervention Type DRUG

Preemptive pregabalin 150 mg administered 1 hour before surgery

Placebo

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

Placebo administered 1 hour before surgery

Interventions

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Pregabalin 150mg

Preemptive pregabalin 150 mg administered 1 hour before surgery

Intervention Type DRUG

Placebo oral capsule

Placebo administered 1 hour before surgery

Intervention Type DRUG

Other Intervention Names

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Vitamin B capsule

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kathmandu University School of Medical Sciences

OTHER

Sponsor Role collaborator

Dhulikhel Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr Ashish Dhakal

Lecturer, Department of Otolaryngology Head and Neck Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dhulikhel Hospital

Dhulikhel, Kavre, Nepal

Site Status

Countries

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Nepal

Other Identifiers

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13/18

Identifier Type: -

Identifier Source: org_study_id

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