Metoclopramide in Children

Concerns

• well-known risks of neurological effects such as short-term extrapyramidal disorders- muscle spasms (often involving the head and neck), and tardive dyskinesia (uncontrollable movements such as grimacing and twitching). 
• The risk of acute (short-term) neurological effects is higher in children
• tardive dyskinesia is reported more often in the elderly, and the risk is increased at high doses or with long-term treatment. 
• The evidence indicated that these risks outweighed the benefits of metoclopramide in conditions requiring long-term treatment. 
• There have also been very rare cases of serious effects on the heart or circulation, particularly after injection

Recommendations from EMA (European Medicines Agency) 
Adult

• remains indicated for prevention of post-operative nausea and vomiting (PONV), radiotherapy-induced nausea and vomiting and delayed (but not acute) chemotherapyinduced nausea and vomiting
• indicated for symptomatic treatment of nausea and vomiting including that associated with acute migraine (where it may also be used to improve absorption of oral analgesics)
• conventional formulations (all routes) is 10 mg up to 3 times daily (max 30mg/day or 0.5mg/kg day)

Children

• only be used as a second-line option for prevention of delayed chemotherapy-induced nausea and vomiting and treatment of established PONV. 
• Use is contraindicated in children under 1 year of age.
• recommended dose is 0.1 to 0.15 mg per kg body weight, repeated up to three times daily

General

• Intravenous doses should be administered as a slow bolus over at least 3 minutes to reduce the risk of adverse effects
• Given very rare reports of serious cardiovascular reactions associated with metoclopramide, particularly via the intravenous route, special care should be taken in populations likely to be at increased risk, including the elderly, patients with cardiac conduction disturbances, uncorrected electrolyte imbalance or bradycardia, and those taking other drugs known to prolong QT interval
• should only be prescribed for short-term use (up to 5 days). 
• Patients who are currently taking regular metoclopramide should have their treatment reviewed at a routine (non-urgent) medical appointment.

Evidences for Recommendations

• no evidence of consistent benefit in gastroparesis, gastro-oesophageal reflux disease and dyspepsia, all of which are chronic conditions requiring prolonged treatment which puts patients at risk of chronic neurological side effects. 
• Evidence to support a role as an adjunct in surgical and radiological procedures was also lacking.
• reporting rate for these disorders was calculated to be 6 times higher in children than in adults
• Cardiovascular reaction reports associated with metoclopramide appeared to be very rare, and mainly associated with intravenous formulations given to patients with underlying risks for cardiac disease; they included hypotension, shock, syncope, bradycardia or atrioventricular block, and cardiac arrest.
• evidence also indicated efficacy in nausea and vomiting associated with acute migraine, but seemed to indicate that doses above 10 mg do not result in increased efficacy

References

1. http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2013/07/WC500146614.pdf
2. http://www.who.int/medicines/publications/Pharm_Newsletter2_2015.pdf
3. MADRAC ADR Newsletter 2007 - September - BPFK
4. Drug Doses