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Efficacy, duration, and absorption of a paediatric oral liquid preparation of ranitidine hydrochloride
G V Goresky1, G A Finley, B Bissonnette
1Department of Anaesthesia, Alberta Children's Hospital, Calgary.
Insights
Oral ranitidine effectively reduced gastric acidity and volume in preoperative children. However, a significant percentage showed no measurable effect, despite adequate serum levels, indicating variable drug response.
Area of Science:
- Pediatric Anesthesiology
- Pharmacology
Background:
- Preoperative gastric acidity and volume management is crucial in pediatric surgery.
- Ranitidine is a commonly used agent to reduce gastric secretions.
Purpose of the Study:
- To evaluate the clinical efficacy of a new oral ranitidine liquid formulation.
- To assess ranitidine's impact on gastric acidity, volume, absorption, and duration of effect in children.
Main Methods:
- A randomized, controlled trial involving 80 preoperative children (1-6 years).
- Participants received either apple juice or water with ranitidine or placebo.
- Gastric fluid pH, volume, and serum ranitidine levels were analyzed.
Main Results:
- Ranitidine administration led to fewer subjects with low pH and high gastric volume.
- The duration of reduced gastric acidity and volume ranged from two to four hours.
- 33% of subjects on ranitidine showed no significant reduction in gastric pH or volume, with 28 having adequate serum levels.
Conclusions:
- Oral ranitidine liquid preparation demonstrates efficacy in reducing gastric acidity and volume in pediatric patients.
- Variability in patient response to ranitidine exists, with some individuals not achieving the desired effect despite adequate drug absorption.
Abstract:
The objectives of this study were to assess the clinical efficacy of a new oral ranitidine liquid preparation in reducing gastric acidity and volume, to determine the degree of absorption of the drug, and to determine the duration of drug effect. Eighty preoperative children between the ages of one and six years were enrolled in each of three centres. Each subject was allocated to one of the following groups: Group A - apple juice, 5 ml.kg-1 plus placebo liquid; Group B - apple juice, 5 ml.kg-1 plus ranitidine hydrochloride 2 mg.kg-1; Group C - water, 5 ml and placebo liquid; or Group D - water, 5 ml and ranitidine liquid 2 mg.kg-1. All study agents were administered at least two hours before surgery along with a dye marker, sulfobromophthalein 1 ml (50 mg.ml-1). Following induction of anaesthesia, gastric fluid was aspirated, and analyzed for pH, volume, and sulfobromophthalein content (as an index of the ingested fluids). A serum sample was also drawn and analyzed for ranitidine content by high performance liquid chromatography. Groups B and D had fewer subjects with pH below 2.5 and gastric volume > 0.4 ml.kg-1. The duration of reduced volume and acidity was shown to be greatest from two to four hours after drug administration. Thirty-three percent of subjects receiving oral ranitidine, 2 mg.kg-1 hydrochloride as a single dose demonstrated no measurable effect on gastric pH and volume; 28 of those subjects had adequate ranitidine serum levels.