Quick answer: In the UK, Pregabalin is not licensed for use in children or adolescents under 18 years of age for nerve pain or generalised anxiety disorder. The safety, long-term cognitive effects, and effectiveness in paediatric populations have not been established. In rare clinical scenarios, a consultant paediatric neurologist may prescribe it off-label for severe, refractory childhood epilepsy using strict weight-based dosing. Never give adult Pregabalin to a child.
The UK licensing position for under-18s
According to the Medicines and Healthcare products Regulatory Agency (MHRA) and the British National Formulary for Children (BNFC):
- Neuropathic Pain: Not licensed. Children experiencing neuropathic pain (e.g. following spinal surgery or oncology treatments) are managed through specialized paediatric chronic pain services using alternative clinical pathways.
- Generalised Anxiety Disorder: Not licensed. Paediatric anxiety must be treated via Child and Adolescent Mental Health Services (CAMHS) using psychological therapies (CBT) and licensed medications (such as fluoxetine) where indicated.
- Epilepsy: Not licensed for general use in children, though specialized tertiary neurological use occurs off-label.
Why is Pregabalin not licensed for children?
Paediatric clinical trials evaluating gabapentinoids in children faced significant challenges:
- Lack of demonstrated superiority: Several paediatric clinical trials in childhood epilepsy and pain failed to demonstrate a statistically significant benefit over placebo.
- Developing brain vulnerability: The developing central nervous system is undergoing rapid synaptic pruning and myelination. Chronic dampening of voltage-gated calcium channels raises theoretical concerns regarding long-term learning, memory formation, and executive cognitive functioning.
- Higher incidence of behavioural side effects: Paediatric patients in clinical studies experienced higher rates of emotional lability, aggressive outbursts, hyperactivity, and paradoxical agitation compared to adults.
Specialist off-label paediatric use in epilepsy
In tertiary children’s hospitals (such as Great Ormond Street Hospital or Alder Hey Children's NHS Foundation Trust), a consultant paediatric neurologist may occasionally prescribe Pregabalin off-label for severe, drug-resistant childhood focal epilepsy when multiple standard anti-seizure medications have failed.
When prescribed by a specialist:
- Weight-based dosing: Doses are calculated strictly in milligrams per kilogram of body weight (mg/kg/day), starting very low and titrating gradually.
- Oral liquid solution: Paediatric patients are prescribed the licensed 20mg/ml oral liquid solution, measured using an accurate calibrated oral syringe.
- Close developmental monitoring: Frequent reviews to assess seizure control, school performance, attention span, and growth.
Emergency action: Accidental child ingestion
Medical emergency: If a toddler or child accidentally swallows adult Pregabalin capsules or liquid, you must treat this as an acute medical poisoning emergency.
Children who ingest adult doses can rapidly experience severe central nervous system depression:
- Profound drowsiness, inability to be woken up, or coma
- Loss of balance, staggering, or falling
- Slow, shallow, or irregular breathing (respiratory depression)
- Sudden seizures, muscle jerks, or vomiting
- Call 999 immediately or take the child to the nearest hospital Emergency Department (A&E).
- Do NOT try to make the child sick: Inducing vomiting in a sedated child risks fatal pulmonary aspiration into the lungs.
- Bring all medication packaging: Hand the blister strips and boxes to the doctors so the hospital can calculate the maximum possible dose ingested.
Child safety in the home: Storing Controlled Drugs
Because Pregabalin is a Class C Controlled Drug with recognized toxicity in children, every patient prescribed Pregabalin must practice strict home safety:
- Store all medication in a high, locked cabinet or lockable medical box out of the reach and sight of children.
- Never leave blister packs on bedside tables, kitchen counters, or inside handbags where curious young children can easily access them.
- Never describe capsules or medicine to children as "sweets" or "candy."
- Return unused or expired Pregabalin to a community pharmacy for safe clinical destruction rather than throwing it in domestic bins.