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Effect of metoclopramide on prolonged intraesophageal pH testing in infants with gastroesophageal reflux
Insights
Higher doses of metoclopramide (MCP) may be needed to effectively treat gastroesophageal reflux (GER) in infants. This study found that only the highest dose significantly reduced reflux episodes in a subset of infants.
Area of Science:
- Pediatric Gastroenterology
- Pharmacology
- Clinical Trial Design
Background:
- Gastroesophageal reflux (GER) is common in infants.
- Metoclopramide (MCP) is a medication sometimes used to manage GER.
- Optimal dosing of MCP for infant GER requires further investigation.
Purpose of the Study:
- To evaluate the efficacy of different doses of metoclopramide (MCP) in infants with gastroesophageal reflux (GER).
- To assess the impact of MCP on intraesophageal pH testing parameters.
- To determine if MCP dosage influences reflux reduction based on feeding type.
Main Methods:
- 42 infants with GER underwent prolonged intraesophageal pH monitoring.
- MCP was administered at doses of 0.1, 0.2, or 0.3 mg/kg.
- Key parameters analyzed included percentage of time pH < 4, reflux frequency, and acid clearance time before and after MCP administration.
Main Results:
- Doses of 0.1 and 0.2 mg/kg MCP showed no significant effect on GER parameters.
- The 0.3 mg/kg dose significantly reduced reflux duration, frequency, and improved acid clearance time in the 2-hour period after 5% dextrose feedings.
- No significant improvements were observed with formula feedings at the 0.3 mg/kg dose.
- Adverse events included irritability and dystonia in a small number of patients.
Conclusions:
- Higher doses of metoclopramide (MCP), specifically 0.3 mg/kg, may be required for effective treatment of GER in infants.
- The efficacy of MCP may be influenced by feeding type.
- Further clinical trials with higher MCP doses are warranted to confirm efficacy and safety in infant GER.
Abstract:
The effect of metoclopramide (MCP) on prolonged intraesophageal pH testing was evaluated in 42 infants with gastroesophageal reflux (GER). Following a baseline period of intraesophageal pH monitoring, MCP was administered by injection at 0.1 mg/kg/dose (10 patients), 0.2 mg/kg/dose (11 patients), or 0.3 mg/kg/dose (21 patients). The percentage of time of intraesophageal pH less than 4, reflux frequency, and acid clearance time were calculated for each subject before and after MCP for both 5% dextrose and formula feedings. These parameters were further separated into 2-hour or shorter and more than 2-hour postprandial periods. No significant differences with either type of feeding were noted at either 0.1 or 0.2 mg/kg/dose. Significant decreases in the percentage of time the intraesophageal pH was less than 4 (30.0 +/- 2.9 versus 15.6 +/- 3.1, p = 0.001), the reflux frequency (episodes/hour; 6.5 +/- 0.9 versus 4.0 +/- 0.6, p = 0.004), and the acid clearance time (minutes/episode; 3.8 +/- 0.7 versus 2.2 +/- 0.3, p = 0.047) were noted in the 2-hour or shorter period following 5% dextrose feedings but not following the formula feedings in the subjects receiving 0.3 mg/kg/dose. Three of the 42 study patients developed increased irritability, and one developed dystonia following MCP. These data suggest that if a clinical trial of MCP in infants with GER is performed, a larger dose of the medication than previously appreciated might be required.