Actively Recruiting

Phase 4
Age: 3Years - 18Years
All Genders
Healthy Volunteers
ID03625011

Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy/Adenoidectomy: Randomized Control Trial

Led by Children's Healthcare of Atlanta · Updated on 2019-07-24

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of gabapentin to reduce pain after tonsillectomy and adenoidectomy in children aged 3 to 18 years. This pilot study aims to see if a single preoperative dose of gabapentin decreases the amount of narcotic pain medicine needed in the first 48 hours after surgery. It also compares the timing of the first pain medicine dose and pain scores at 12, 24, and 48 hours after surgery using pain scales like Wong Baker and a numeric distress scale. In this double-blind randomized controlled trial, 50 children undergoing tonsillectomy and adenoidectomy will be randomly assigned to receive either one dose of gabapentin (15 mg/kg up to 600 mg) or a placebo before surgery. Both groups will receive the usual narcotic pain treatment during surgery. After surgery, younger children will be guided to take Tylenol and Motrin, while teenagers will get a narcotic prescription. The study will measure the amount of each pain medicine used and the time to first pain medicine. Participants will be monitored through phone calls with a research nurse for three days after surgery to collect pain scores at specified times. Researchers will track the total narcotic consumption during the first 48 hours after surgery as the main outcome. The study also looks at the timing of the first pain medicine and pain levels at 12, 24, and 48 hours. This detailed follow-up helps evaluate how gabapentin affects pain control in children after these common surgeries.

CONDITIONS

Brief Title

Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy

Who Can Participate

Age: 3Years - 18Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants aged 3 to 18 years
  • Classified as ASA class 1 or 2
  • Scheduled for elective tonsillectomy or adenoidectomy
  • Surgery planned in an outpatient setting
Not Eligible

You will not qualify if you...

  • Body mass index (BMI) greater than 40 kg/m2
  • History of kidney problems or chronic pain
  • Known allergy to gabapentin
  • History of developmental delay

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Day of surgery

Participants receive either a single dose of gabapentin or placebo before surgery, followed by standard narcotic pain management during tonsillectomy or adenoidectomy surgery.

1 visit (preoperative dosing and surgery)

Post-operative Follow-up

Duration - 3 days postoperatively

Participants are followed up with phone interviews by a research nurse to assess pain scores and analgesic use for 3 days after surgery.

Phone interviews at 12, 24, and 48 hours postoperatively

Trial Site Locations

Total: 1 location

1

Children's Healthcare of Atlanta

Atlanta, Georgia, United States, 30329

Actively Recruiting

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Research Team

B

Beena Desai

M

Margaret A Gettis, DNP,CPNP-PC

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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Published Research Related To This Trial

Opioid use disorder and misuse: A review of the epidemiology and medical implications for pediatric anesthesiologists.

Emily Knipper, Caleb J Banta-Green, Nathalia Jimenez

https://pubmed.ncbi.nlm.nih.gov/29030938