RESUMO
BACKGROUND: The aim was to investigate whether children experience less fear, distress, and/or pain when they receive oral morphine vs. placebo before a needle is inserted in a subcutaneously implanted intravenous port when combined with topical anesthesia. METHOD: Fifty children 1-18 years of age who were treated in a pediatric oncology and hematology setting were included consecutively when undergoing routine needle insertion into an intravenous port. All children were subjected to one needle insertion following topical anesthetic (EMLA) application in this randomized, triple-blind, placebo-controlled study comparing orally administered morphine (n=26) 0.25 mg/kg body weight with placebo (n=24). The patients' fear, distress, and pain were reported by parents, nurses and the children themselves (if ≥ 7 years of age) on 0-100 mm Visual Analogue Scales. In addition, observational methods were used to measure distress and procedure pain. RESULTS: No differences between the morphine and the placebo group were found with respect to age, weight, height, physical status, sex, weeks from diagnosis, or weeks from latest needle insertion. According to, parents, nurses, and children, oral morphine at a dose of 0.25 mg/kg body weight did not reduce fear, distress or pain compared with placebo. CONCLUSION: We could not reject the null hypothesis that there is no difference between the oral morphine and placebo groups assuming an effect size of 15 mm on VAS. Therefore it seems that oral morphine at 0.25 mg/kg does not give any additional reduction of fear, distress or pain compared with placebo when combined with topical anesthesia in pediatric patients undergoing subcutaneous port needle insertion, and would not be expected to be of any advantage for similar procedures such as venipuncture and venous cannulation when topical anesthesia is used.
