Gabapentin for Postoperative Pain in Children
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: University of California, Davis
Must not be taking: Opioids
Disqualifiers: Renal failure, Seizures, Chronic pain, Autism, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?The primary objective of this study is to determine if the peri and post operative use of gabapentin in children reduces the need for narcotics after thoracic surgery.
We hypothesize that patients who are given gabapentin will need fewer morphine equivalents postoperatively than those who were not given gabapentin
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used opioids in the last 30 days or if you have a history of seizures requiring treatment.
What data supports the effectiveness of the drug gabapentin for postoperative pain in children?
Research in adults shows gabapentin can help with pain after surgery, and studies suggest it might reduce the need for strong painkillers like morphine. However, there is limited direct evidence for its use in children after surgery.
12345Is gabapentin safe for use in children for postoperative pain?
Gabapentin is often used off-label for pain management in children, and studies have looked at its safety when used with other pain medications like morphine. While it is generally considered safe, its use in children for postoperative pain is still being studied to ensure there are no unexpected side effects.
12678How is the drug gabapentin unique for treating postoperative pain in children?
Gabapentin is unique because it is used off-label as an opioid-sparing medication, meaning it can reduce the need for stronger painkillers like morphine after surgery. It is also being studied in a new liquid form specifically for children, which could make it easier to administer.
6891011Eligibility Criteria
This trial is for children from newborns up to under 18 years old who are undergoing thoracic surgery and will stay in the hospital for at least 48 hours. They must be born after a full-term pregnancy (at least 38 weeks). Children with autism, kidney failure, current participation in another study, opioid use within the last month, chronic pain treatment, active seizure disorders or those unable to take oral medication cannot join.Inclusion Criteria
I am under 18 years old.
I am scheduled for a chest surgery that is not related to my heart.
I have had surgery in my chest area.
+3 more
Exclusion Criteria
Pregnancy
I have used opioids in the last 30 days.
Participation in another clinical study presently or within the last 30 days
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive gabapentin or placebo perioperatively and postoperatively to assess its impact on opioid use and pain management
7 days
Daily monitoring during hospital stay
Follow-up
Participants are monitored for safety and effectiveness after treatment, focusing on opioid use, pain scores, and potential adverse effects
7 days post-operative or until discharge
Participant Groups
The trial is testing whether gabapentin can reduce the need for opioid painkillers after thoracic surgery in children. Participants will either receive gabapentin or a placebo during and after their operation to compare how much narcotic medication they'll need post-surgery.
2Treatment groups
Active Control
Placebo Group
Group I: Gabapentin TreatmentActive Control1 Intervention
Given at a dose of 10mg/kg (max 600mg) perioperatively (immediately prior to surgery) followed by 3mg/kg/dose TID with first dose to be given starting at 8 hours post perioperative dose.
Group II: Control GroupPlacebo Group1 Intervention
Given placebo which coincides with the active treatment group
Gabapentin is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Neurontin for:
- Postherpetic neuralgia
- Partial-onset seizures
🇪🇺 Approved in European Union as Gabapentin for:
- Peripheral neuropathic pain
- Partial-onset seizures
🇨🇦 Approved in Canada as Gabapentin for:
- Postherpetic neuralgia
- Partial-onset seizures
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UC Davis Medical CenterSacramento, CA
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Who Is Running the Clinical Trial?
University of California, DavisLead Sponsor
References
Does the addition of post-operative gabapentin reduce the use of narcotics after orthopedic surgery? [2023]To evaluate the efficacy of post-operative gabapentin administration as an analgesic agent and its effect on narcotic use after orthopedic surgery in an outpatient sports medicine practice by comparing patients prior to and after initiating the routine use of gabapentin as part of a standardized post-operative pain medication regimen. We hypothesized that adding gabapentin to a multimodal post-operative pain regimen would decrease the number of requested pain medication refills and have no detrimental effect on Visual Analogue Scale and Single Assessment Numerical Evaluation scores at these early post-operative visits.
Effectiveness, cost-effectiveness and safety of gabapentin versus placebo as an adjunct to multimodal pain regimens in surgical patients: protocol of a placebo controlled randomised controlled trial with blinding (GAP study). [2021]Gabapentin is an antiepileptic drug currently licensed to treat epilepsy and neuropathic pain but has been used off-label to treat acute postoperative pain. The GAP study will compare the effectiveness, cost-effectiveness and safety of gabapentin as an adjunct to standard multimodal analgesia versus placebo for the management of pain after major surgery.
Evidence for the Efficacy of Systemic Opioid-Sparing Analgesics in Pediatric Surgical Populations: A Systematic Review. [2022]While a large number of studies has examined the efficacy of opioid-sparing analgesics in adult surgical populations, fewer studies are available to guide postoperative pain treatment in pediatric patients. We systematically reviewed available publications on the use of systemic nonopioid agents for postoperative analgesia in pediatric surgical populations. A comprehensive literature search identified meta-analyses and randomized controlled trials (RCTs) assessing the effects of systemic, nonopioid agents on postoperative narcotic requirements or pain scores in pediatric surgical populations. If a meta-analysis was located, we summarized its results and any RCTs published after it. We located and reviewed 11 acetaminophen RCTs, 1 nonsteroidal anti-inflammatory drug (NSAID) meta-analysis, 2 NSAID RCTs, 1 dexamethasone meta-analysis, 3 dexamethasone RCTs, 2 ketamine meta-analyses, 5 ketamine RCTs, 2 gabapentin RCTs, 1 clonidine meta-analysis, 3 magnesium RCTs, 2 dexmedetomidine meta-analyses, and 1 dextromethorphan RCT. No meta-analyses or RCTs were found assessing the perioperative efficacy of intravenous lidocaine, amantadine, pregabalin, esmolol, or caffeine in pediatric surgical patients. The available evidence is limited, but suggests that perioperative acetaminophen, NSAIDs, dexamethasone, ketamine, clonidine, and dexmedetomidine may decrease postoperative pain and opioid consumption in some pediatric surgical populations. Not enough, or no, data exist from which to draw conclusions on the perioperative use of gabapentin, magnesium, dextromethorphan, lidocaine, amantadine, pregabalin, esmolol, and caffeine in pediatric surgical patients. Further pharmacokinetic and pharmacodynamics studies to establish both the clinical benefit and efficacy of nonopioid analgesia in pediatric populations are needed.
Reanalysis of morphine consumption from two randomized controlled trials of gabapentin using longitudinal statistical methods. [2022]Postoperative pain management in total joint replacement surgery remains ineffective in up to 50% of patients and has an overwhelming impact in terms of patient well-being and health care burden. We present here an empirical analysis of two randomized controlled trials assessing whether addition of gabapentin to a multimodal perioperative analgesia regimen can reduce morphine consumption or improve analgesia for patients following total joint arthroplasty (the MOBILE trials).
The Effect of Gabapentin on Postoperative Pain of Orthopedic Surgery of Lower Limb by Sciatic and Femoral Blockage in Children: A Clinical Trial. [2022]There are meta-analyzes in adults demonstrating the benefits of using gabapentin to improve postoperative pain in orthopedic surgeries. In pediatrics, it has never been studied.
Gabapentin as add-on to morphine for severe neuropathic or mixed pain in children from age 3 months to 18 years - evaluation of the safety, pharmacokinetics, and efficacy of a new gabapentin liquid formulation: study protocol for a randomized controlled trial. [2020]Gabapentin has shown efficacy in the treatment of chronic neuropathic or mixed pain in adults. Although pediatric pain specialists have extensive experience with gabapentin for the treatment of neuropathic pain, its use is off-label. Its efficacy and safety in this context have never been shown. The aim of this trial is to compare gabapentin with placebo as add-on to morphine for the treatment of severe chronic mixed or neuropathic pain in children. This trial is part of the European Union Seventh Framework Programme project Gabapentin in Paediatric Pain (GAPP) to develop a pediatric use marketing authorization for a new gabapentin suspension.
The efficacy of gabapentin in reducing pain intensity and morphine consumption after breast cancer surgery: A meta-analysis. [2022]The purpose of this meta-analysis from randomized controlled trials (RCTs) was to determine the efficacy and safety of the preoperative use of gabapentin for the treatment of acute and chronic postoperative pain following breast cancer surgery.
Gabapentin is Associated With Decreased Postoperative Opioid Use and Length of Stay After Appendectomy in Children With Perforated Appendicitis: A Propensity Score-Matched Analysis. [2023]Gabapentin is increasingly used as an off-label, opioid-sparing pain medication in children. We investigated perioperative gabapentin administration and postoperative opioid use in children who underwent appendectomy for perforated appendicitis.
Single dose oral gabapentin for established acute postoperative pain in adults. [2023]Gabapentin is an antiepileptic drug, also used in the treatment of neuropathic pain, which is the subject of a Cochrane review, currently under revision. Its efficacy in treating established acute postoperative pain has not been demonstrated.
Effectiveness of gabapentin as a postoperative analgesic in children undergoing appendectomy. [2020]Though gabapentin is increasingly used as a perioperative analgesic, data regarding effectiveness in children are limited. The purpose of this study was to evaluate gabapentin as a postoperative analgesic in children undergoing appendectomy.
Evaluation of gabapentin and dexamethasone alone or in combination for pain control after adenotonsillectomy in children. [2021]Different methods and many drugs have been used to control the post-operative pain. In this study, we evaluate the role of gabapentin premedication and/or dexamethasone in management of post-operative pain following adenotonsillectomy in children.