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Preemptive Pregabalin in Myringoplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn (the article is not a clinical trial but is a hospital based randomized comparative study.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
Sponsor:
Collaborator:
Kathmandu University School of Medical Sciences
Information provided by (Responsible Party):
Dr Ashish Dhakal, Dhulikhel Hospital

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

Condition or disease Intervention/treatment Phase
Post-operative Analgesia CSOM - Chronic Suppurative Otitis Media Drug: Pregabalin 150mg Drug: Placebo oral capsule Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Nepal
Dhulikhel Hospital
Dhulikhel, Kavre, Nepal, 45210
Sponsors and Collaborators
Dhulikhel Hospital
Kathmandu University School of Medical Sciences
More Information
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Responsible Party: Dr Ashish Dhakal, Lecturer, Department of Otolaryngology Head and Neck Surgery, Dhulikhel Hospital
ClinicalTrials.gov Identifier: NCT03603626    
Other Study ID Numbers: 13/18
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Ashish Dhakal, Dhulikhel Hospital:
Endoscopic ear surgery
Myringoplasty
Pregabalin
Preemptive analgesia
Additional relevant MeSH terms:
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Otitis Media, Suppurative
Otitis Media
Otitis
Ear Diseases
Otorhinolaryngologic Diseases
Suppuration
Infections
Pregabalin
Physiological Effects of Drugs
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs