Study Results
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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WITHDRAWN
NA
INTERVENTIONAL
2015-09-30
2017-12-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Preemptive pregabalin
Pregabalin 150mg
Preemptive pregabalin 150 mg administered 1 hour before surgery
Placebo
Placebo oral capsule
Placebo administered 1 hour before surgery
Interventions
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Pregabalin 150mg
Preemptive pregabalin 150 mg administered 1 hour before surgery
Placebo oral capsule
Placebo administered 1 hour before surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \>= 18 years
* either sex.
Exclusion Criteria
* Pregnancy or breastfeeding,
* Known or suspected sensitivity or contraindication to pregabalin,
* Patient using medication for chronic pain,
* History of seizure disorder,
* Mental retardation.
18 Years
60 Years
ALL
No
Sponsors
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Kathmandu University School of Medical Sciences
OTHER
Dhulikhel Hospital
OTHER
Responsible Party
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Dr Ashish Dhakal
Lecturer, Department of Otolaryngology Head and Neck Surgery
Locations
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Dhulikhel Hospital
Dhulikhel, Kavre, Nepal
Countries
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Other Identifiers
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13/18
Identifier Type: -
Identifier Source: org_study_id
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