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NCT03625011 · ClinicalTrials.gov registry record · Phase 4
Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy
A Phase 4 study of Tonsillitis and Tonsillectomy, sponsored by Children's Healthcare of Atlanta.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT03625011: Recruiting Phase 4 study of Tonsillitis and Tonsillectomy, sponsored by Children's Healthcare of Atlanta.
NCT03625011 is a Phase 4 study of Tonsillitis and Tonsillectomy that is actively recruiting participants, run by Children's Healthcare of Atlanta. The registered enrollment target is 50 participants, below the 384-participant average among 6 other Tonsillitis trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03625011, a Phase 4 study of Tonsillitis and Tonsillectomy, is actively recruiting participants, sponsored by Children's Healthcare of Atlanta.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
To examine the use of gabapentin in reducing pain in the first 48 hours postoperatively including the total amount of narcotics mg/kg(weight and height will be combined to report BMI in kg/m\^2).
Conditions Studied
Interventions
- DRUG Gabapentin
Study Locations (1)
Georgia
- Children's Healthcare of Atlanta - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2018-07-31 |
| Est. Completion | 2019-12-31 |
| Phase | Phase 4 |
What NCT03625011 shows while recruiting
NCT03625011 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 384-participant average among 6 other Tonsillitis trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with Tonsillitis appearing as the primary indexed condition, and to 1 intervention - of which Gabapentin is the first listed.
NCT03625011 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT03625011 about?
NCT03625011 is a clinical study titled "Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy". 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 sca...
What is the current status of trial NCT03625011?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2018-07-31. Estimated completion is 2019-12-31.
What conditions does trial NCT03625011 study?
This clinical trial studies the following conditions: Tonsillitis, Tonsillectomy.
What interventions are being tested in trial NCT03625011?
The interventions under investigation include: Gabapentin (DRUG).
Who is sponsoring clinical trial NCT03625011?
This trial is sponsored by Children's Healthcare of Atlanta, which has 80 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03625011 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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