Effects of Oral Gabapentin, Local Bupivacaine and Intravenous Pethidine on Post Tonsillectomy Pain.
Soroush Amani, Mohamad Reza Abedinzadeh
https://pubmed.ncbi.nlm.nih.gov/26568937Actively Recruiting
Led by Children's Healthcare of Atlanta · Updated on 2019-07-24
50
Participants Needed
1
Research Sites
N/A
Total Duration
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
Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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)
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
Total: 1 location
1
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30329
Actively Recruiting
B
Beena Desai
M
Margaret A Gettis, DNP,CPNP-PC
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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