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Gabapentin Group for Tonsillitis

Phase 4
Recruiting
Research Sponsored by Children's Healthcare of Atlanta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12, 24 and 48 hours postoperatively.
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
Drug Has Already Been Approved

Summary

The purpose of this pilot study: 1) to examine the use of gabapentin in reducing pain in the first 48 hours postoperatively including the total amount of narcotics mg/kg given 2) to record the time to first analgesic postoperatively and 3) to compare Wong Baker and the 0-10 numeric pain distress scale scores at 12, 24 and 48 hours postoperatively. We hypothesize one 15mg/kg (up to 600mg) dose of gabapentin will decrease mean narcotic amounts in mg/kg compared to participants who do not receive preoperative gabapentin and will demonstrate a decreased mean time to first analgesic as well as to lower mean pain scores for each age group at 12, 24 and 48 hours.

Eligible Conditions
  • Tonsillitis
  • Tonsillectomy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12, 24 and 48 hours postoperatively.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12, 24 and 48 hours postoperatively. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Narcotic Consumption
Secondary study objectives
First Analgesic Timing
Pain Scale Scores

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Gabapentin GroupActive Control1 Intervention
Participants will be randomized to either Control Group or Gabapentin Group
Group II: Placebo GroupPlacebo Group1 Intervention
Participants will be randomized to either Control Group or Gabapentin Group

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Who is running the clinical trial?

Children's Healthcare of AtlantaLead Sponsor
169 Previous Clinical Trials
107,068 Total Patients Enrolled
Christina Calamaro, PhD, CPNP-PCStudy ChairInstitutional Review Board
~7 spots leftby Nov 2025
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