Preemptive Pregabalin in Myringoplasty

NCT03603626 | Withdrawn

• 1 other identifier: 13/18
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post-operative Analgesia; CSOM - Chronic Suppurative Otitis Media

Keywords

Endoscopic ear surgery; Myringoplasty; Pregabalin; Preemptive analgesia

Outcome Measures

Primary Outcomes (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.

  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.

  At 6, 12, 24, 48 hours in postoperative period

Study Arms (2)

Preemptive pregabalin

EXPERIMENTAL

Drug: Pregabalin 150mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo oral capsule

Interventions

Pregabalin 150mg DRUG

Preemptive pregabalin 150 mg administered 1 hour before surgery

Preemptive pregabalin

Placebo oral capsule DRUG

Placebo administered 1 hour before surgery

Also known as: Vitamin B capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Cases of Chronic suppurative otitis media (CSOM) inactive planned for endoscopic myringoplasty under local anesthesia,
• Age \>= 18 years
• either sex.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dhulikhel Hospital: lead
• Kathmandu University School of Medical Sciences: collaborator

Study Sites (1)

Dhulikhel Hospital

Dhulikhel, Kavre, 45210, Nepal

Location

MeSH Terms

Interventions

Pregabalin; Folic Acid

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Department of Otolaryngology Head and Neck Surgery

Study Record Dates

• First Submitted: July 7, 2018
• First Posted: July 27, 2018
• Study Start: September 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 24, 2018

Record last verified: 2018-09

Locations

NE (1)