Journal of pediatric surgery · 2005
Effectiveness of alimemazine in controlling retching after Nissen fundoplication.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Antao Brice, Ooi Kuan, Ade-Ajayi Nye, Stevens Ben, Spitz Lewis
Аннотация
BACKGROUND: Retching, an early component of the emetic reflex, is a common and distressing symptom in children after Nissen fundoplication. Alimemazine (trimeprazine, Vallergan; Castlemead, Herts, UK) is a phenothiazine derivative histamine(1) antagonist, which anecdotally relieves the retching symptoms.
MATERIAL AND METHODS: A prospective, double-blind, randomized, crossover, placebo-controlled study of 15 neurologically impaired children with retching after Nissen fundoplication over a period of 1 year (December 2002-December 2003). Patients were randomly allocated to receive 1 week each of alimemazine and placebo with crossover. A diary was maintained of retching episodes 1 week before, during, and 1 week after the trial. Dosage of alimemazine used was 0.25 mg/kg 3 times a day (maximum, 2.5 mg per dose). Statistical analysis was done using a paired Student's t test, where P value of less than .05 was considered significant. Results are presented as mean +/- SD.
RESULTS: Twelve parents completed the diaries (9 open, 3 laparoscopic Nissen fundoplication). Median age of the child was 36 months (8-180 months), median duration of retching was 4.5 months (1-52 months), and mean number of retching episodes per week was 60 +/- 29.40. Mean number of retching episodes with alimemazine was 10.42 +/- 9.48 vs 47.67 +/- 27.79 with a placebo (P < .0001). No adverse effects were reported in those cases that completed the study.
CONCLUSION: At low dose, alimemazine (Vallergan) is a safe and effective drug in the management of retching after Nissen fundoplication.
MATERIAL AND METHODS: A prospective, double-blind, randomized, crossover, placebo-controlled study of 15 neurologically impaired children with retching after Nissen fundoplication over a period of 1 year (December 2002-December 2003). Patients were randomly allocated to receive 1 week each of alimemazine and placebo with crossover. A diary was maintained of retching episodes 1 week before, during, and 1 week after the trial. Dosage of alimemazine used was 0.25 mg/kg 3 times a day (maximum, 2.5 mg per dose). Statistical analysis was done using a paired Student's t test, where P value of less than .05 was considered significant. Results are presented as mean +/- SD.
RESULTS: Twelve parents completed the diaries (9 open, 3 laparoscopic Nissen fundoplication). Median age of the child was 36 months (8-180 months), median duration of retching was 4.5 months (1-52 months), and mean number of retching episodes per week was 60 +/- 29.40. Mean number of retching episodes with alimemazine was 10.42 +/- 9.48 vs 47.67 +/- 27.79 with a placebo (P < .0001). No adverse effects were reported in those cases that completed the study.
CONCLUSION: At low dose, alimemazine (Vallergan) is a safe and effective drug in the management of retching after Nissen fundoplication.