Gabapentin for Neuropathic Pain in Children
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of British Columbia
Disqualifiers: Renal disease, Hepatic impairment, Sickle cell, others
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?Children born with severe brain-based developmental disabilities frequently experience persistent unexplained periods of pain and irritability, often compounded by a limited capacity to communicate their distress. The investigators call this entity Pain and Irritability of Unknown Origin (PIUO). The rationale of this trial is to identify the clinical effect size of gabapentin in reducing and resolving pain in children with developmental brain disorders, specifically those with severe neurological impairment (SNI).
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications. It's best to discuss this with the trial coordinators or your doctor.
What evidence supports the effectiveness of the drug gabapentin for treating neuropathic pain in children?
Gabapentin has been shown to help reduce neuropathic pain in children, as seen in a report where five adolescents experienced significant pain relief with minimal side effects. Additionally, a case study highlighted a 12-year-old boy whose severe pain improved significantly after using gabapentin.
12345Is gabapentin safe for treating neuropathic pain in children?
Gabapentin has been used to treat neuropathic pain in children with minimal side effects reported in some cases, but its safety and effectiveness are not fully established, and more research is needed.
12467How is the drug gabapentin unique for treating neuropathic pain in children?
Gabapentin is unique because it is originally an antiepileptic drug that has shown effectiveness in reducing neuropathic pain in children with minimal side effects, even though its use for this purpose is off-label (not officially approved). It can be used as an add-on to morphine for severe pain and is being studied in a new liquid form for easier administration in children.
12456Eligibility Criteria
This trial is for children aged 6 months to 18 years with severe neurological impairment who experience unexplained pain and irritability. They must have significant communication or cognitive disabilities, scoring high on specific scales indicating persistent distress without an obvious cause.Inclusion Criteria
My child, aged 6 months to 18 years, has severe neurological issues and unexplained pain or irritability.
My child's medical history shows they've been fully checked for treatable pain causes.
My child has severe cognitive or communication issues and significant physical limitations.
+1 more
Exclusion Criteria
My kidney function is reduced with a filtration rate below 60 mL/min.
My child can point to or tell where it hurts.
I have been diagnosed with pain and irritability.
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive gabapentin or placebo in a randomized cross-over design, with dose titration every 3-4 days
26 days per sequence
Weekly assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
Long-term
Participant Groups
The trial tests the effectiveness of Gabapentin in alleviating pain compared to a placebo in children with severe brain-based developmental disabilities. It aims to determine how well Gabapentin can reduce or resolve their pain and irritability.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MedicationExperimental Treatment1 Intervention
Gabapentin is clinically started at a low dose and titrated to clinical effect or maximum target dose, whichever is lower.
The starting dose of gabapentin will be 5 mg/kg administered as oral liquid or via gastric or jejunal routes. On Day 1 of the study, the gabapentin will be administered once at bedtime and then increased according to a preset schedule. The dose will be increased every 3rd - 4th day in a step wise fashion of 13% - 50%, starting with the evening dose in order to accommodate sedation. The maximum dose for subjects will be as follows: \< 15 kg to 60 mg/kg day and ≥15 kg to 45 mg/kg/day.
Group II: PlaceboPlacebo Group1 Intervention
Participants on this arm receive placebo, masked and dispensed according to the same preset schedule as the Medication arm.
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:
BC Children's HospitalVancouver, Canada
Loading ...
Who Is Running the Clinical Trial?
University of British ColumbiaLead Sponsor
BC Children's Hospital Research InstituteCollaborator
Canadian Institutes of Health Research (CIHR)Collaborator
Child-Bright NetworkCollaborator
References
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.
Experience with gabapentin for neuropathic pain in adolescents: report of five cases. [2018]Summary Gabapentin is an antiepileptic drug indicated for the treatment of partial seizures in children. Many studies have proved its analgesic action in the treatment of neuropathic pain in adults and we have noticed an analgesic action of gabapentin in neuropathic pain in children. Five patients treated in the Children's Hospital Pain Control Service for intractable neuropathic pain were included in gabapentin treatment. Four were cancer patients and one suffered from neuropathic pain in the neck (C3). The visual analog scale (VAS) scores of pain were compared before and during treatment with gabapentin. We noticed a rapid improvement, in 1 week, of our patients' VAS scores (from 9 or 10 to 4 or 3) with minimal adverse effects. In the follow-up period of 6 months we gradually reduced the dose of gabapentin. Our findings are that gabapentin should be included earlier in the treatment of neuropathic pain in adolescents, because it rapidly improves analgesia and has minimal side effects.
Gabapentin Treatment for Neuropathic Pain in a Child with Sciatic Nerve Injury. [2020]There are a restricted number of studies about usage of gabapentin for neuropathic pain treatment of pediatric patients. We shared a 12-year-old male case with severe neuropathic pain that hindered the rehabilitation programme for the loss of muscle power and movement limitation. Neuropathic pain developed after peripheral sciatic damage due to firearm traumatisation did not respond to other medical treatments but healed nearly completely after gabapentin usage.
Non-inferiority double-blind randomised controlled trial comparing gabapentin versus tramadol for the treatment of chronic neuropathic or mixed pain in children and adolescents: the GABA-1 trial-a study protocol. [2020]Gabapentin is currently used 'off-label' in children and adolescents with chronic neuropathic pain, and reliable evidence of its effects and optimal dosing are lacking.
Diagnosis and Treatment of Chronic Neuropathic and Mixed Pain in Children and Adolescents: Results of a Survey Study amongst Practitioners. [2020]Validated diagnostic tools to diagnose chronic neuropathic and mixed pain in children are missing. Therapeutic options are often derived from therapeutics for adults. To investigate the international practice amongst practitioners for the diagnosis and treatment of chronic, neuropathic pain in children and adolescents, we performed a survey study among members of learned societies or groups whose members are known to treat pediatric pain. The survey included questions concerning practitioners and practice characteristics, assessment and diagnosis, treatment and medication. We analyzed 117 returned questionnaires, of which 41 (35%) were fully completed and 76 (65%) were partially completed. Most respondents based the diagnosis of neuropathic pain on physical examination (68 (58.1%)), patient history (67 (57.3%)), and underlying disease (59 (50.4%)) combined. Gabapentin, amitriptyline, and pregabalin were the first-choice treatments for moderate neuropathic pain. Tramadol, ibuprofen, amitriptyline, and paracetamol were the first-choice treatments for moderate mixed pain. Consensus on the diagnostic process of neuropathic pain in children and adolescents is lacking. Drug treatment varies widely for moderate, severe neuropathic, and mixed pain. Hence, diagnostic tools and therapy need to be harmonized and validated for use in children.
[Gabapentin for neurophatic pain in children: a case report]. [2018]Gabapentin is used as an analgesic in neuropathic pain. In this report a children with nerophatic pain because of mercury poising was followed-up for pain and side effects with the use of gabapentin. Pain reduction was good throughout the patient treatment. Severe side effects did not occur. Gabapentin was effective and well tolerated in the treatment of neuropathic pain in children.
Restoring invisible and abandoned trials of gabapentin for neuropathic pain: a clinical and methodological investigation. [2022]Gabapentin (Neurontin) is prescribed widely for conditions for which it has not been approved by regulators, including certain neuropathic pain conditions. There is limited evidence that gabapentin is safe and effective for the treatment of neuropathic pain. Published trial reports, and systematic reviews based on published trial reports, mislead patients and providers because information about gabapentin's harms has been published only partly. We confirmed that trials conducted by the drug developer have been abandoned, and we plan to conduct a restoration with support from the Restoring Invisible and Abandoned Trials Support Centre (https://restoringtrials.org/).