Preemptive Pregabalin in Myringoplasty
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|ClinicalTrials.gov Identifier: NCT03603626|
Recruitment Status : Withdrawn (the article is not a clinical trial but is a hospital based randomized comparative study. This was inadvertently uploaded.)
First Posted : July 27, 2018
Last Update Posted : September 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Post-operative Analgesia CSOM - Chronic Suppurative Otitis Media||Drug: Pregabalin 150mg Drug: Placebo oral capsule||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of Preemptive Pregabalin for Post-operative Pain Relief in Myringoplasty|
|Actual Study Start Date :||September 2015|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
|Experimental: Preemptive pregabalin||
Drug: Pregabalin 150mg
Preemptive pregabalin 150 mg administered 1 hour before surgery
|Placebo Comparator: Placebo||
Drug: Placebo oral capsule
Placebo administered 1 hour before surgery
Other Name: Vitamin B capsule
- This study is constructed to determine whether the use of preemptive single dose oral pregabalin would decrease post-operative pain in patient undergoing myringoplasty. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03603626
|Dhulikhel, Kavre, Nepal, 45210|