A Phase 4 interventional study of Gabapentin in Tonsillitis and Tonsillectomy, sponsored by Children's Healthcare of Atlanta. Recruiting at 1 site in United States. Open to participants aged 3 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-24.
Sponsored by Children's Healthcare of Atlanta · Phase 4, Interventional, and Health services research
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.
This double blinded randomized control trial will enroll 50 children age 3-18 years, undergoing T/As from a regional healthcare organization. Patients will be receiving either one gabapentin dose (15mg/kg up to 600mg) or placebo preoperatively. Both control and test group will receive the standard narcotic regimen intraoperatively. Additionally, young children will receive instruction for Tylenol and Motrin postoperatively while teenagers will receive a narcotic prescription. Outcome measurements include: mean Tylenol mg/kg, Motrin mg/kg and narcotic mg/kg use. Additional measurements: Mean time to first analgesic. Phone interviews with the research nurse for three days postoperatively will elicit pain scores at 12, 24 and 48 hours postoperatively.
103 studies on the registry are indexed under Tonsillitis; 12 are open to participants now.
This study's planned enrollment of 50 is below the median of 100 across 87 interventional studies indexed under Tonsillitis.
Browse Tonsillitis studies →Children's Healthcare of Atlanta is the lead sponsor of 97 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be randomized to either Control Group or Gabapentin Group
Drug: Gabapentin
Participants will be randomized to either Control Group or Gabapentin Group
Drug: Gabapentin
This double blinded randomized control trial will enroll 50 children age 3-18 years, undergoing T/As. Patients will be receiving either one gabapentin dose (15mg/kg up to 600mg) or placebo preoperatively. Both control and test group will receive the standard narcotic regimen intraoperatively.
Also known as: Neurontin
Narcotic Consumption
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).
Time frame: First 48 hours postoperatively
First Analgesic Timing
To record the time to first analgesic postoperatively
Time frame: First 48 Hours postoperatively
Pain Scale Scores
To compare the Wong- Baker FACES Pain Rating Scale and the 1-10 numeric pain distress scale pain scores at 12, 24 and 48 hours postoperatively. The 0-10 Numeric Pain Distress Pain Scale utilizes number gradations to describe pain for school age children and adolescents. A zero score means the absence of pain while a five describes distressing pain and a ten infers unbearable pain. As for the Wong-Baker FACES Scale, a series of faces can be shown to children over the age of three. The six faces depict facial expressions with zero-no hurt at all, one-hurts just a little bit, two-hurts a little more, three-hurts even more, four-hurts a whole lot, and five- hurts as much as you can imagine. No subscales will be used or combined.
Time frame: 12, 24 and 48 hours postoperatively.
PDFs hosted by the registry, ClinicalTrials.gov.
Started Jul 2018 (actual). Primary completion is estimated for Dec 2019, 17 months after the start.
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Studies of the drug tested here: Gabapentin
Children's Healthcare of Atlanta