NCT03625011 Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy
| NCT ID | NCT03625011 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Children's Healthcare of Atlanta |
| Condition | Tonsillitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2018-07-31 |
| Primary Completion | 2019-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2018-07-31 with a primary completion date of 2019-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * participants age 3-18 years * ASA class 1 or 2 * elective Tonsillectomy/Adenoidectomy * outpatient setting. Exclusion Criteria: * BMI \>40kg/m2 * history of renal insufficiency, chronic pain * allergy to gabapentin * history of developmental delay
Contact & Investigator
Christina Calamaro, PhD, CPNP-PC
STUDY CHAIR
Institutional Review Board
Frequently Asked Questions
Who can join the NCT03625011 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 18 Years, studying Tonsillitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03625011 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03625011 currently recruiting?
Yes, NCT03625011 is actively recruiting participants. Contact the research team at beena.desai@choa.org for enrollment information.
Where is the NCT03625011 trial being conducted?
This trial is being conducted at Atlanta, United States.
Who is sponsoring the NCT03625011 clinical trial?
NCT03625011 is sponsored by Children's Healthcare of Atlanta. The principal investigator is Christina Calamaro, PhD, CPNP-PC at Institutional Review Board. The trial plans to enroll 50 participants.