[Clinical trials with acemetacin on children and adolescents (author's transl)].
In a controlled double blind study [1-(p-chlorobenzoyl)-5-methoxy-2-methylindol-3-acetoxy] acetic acid (acemetacin, TV 1322, Rantudil) was compared with indometacin in 60 (male and female) children and adolescents. the analgesic, anti-inflammatory and antipyretic efficacy and tolerability were investigated postoperatively and post-traumatically. The analgesic effect was good to very good in 76.7% of the patients treated with acemetacin; in the indometacin group it was only 66.7%. The remaining cases received an additional analgesic. The anti-inflammatory effect of both drugs was good. None of the postoperatively or post-traumatically applied plasters had to be opened. The statistical evaluation showed a very good therapeutic effect in both groups after 5 days of treatment (pain reduction approx. 90%, detumescence approx. 85%). The body temperatures in the acemetacin group as well as in the indometacin group also changed significantly. Except for vomiting by one patient of the indometacin group no undesired side effects were observed. Consequently the tolerability of acemetacin is very good. Acemetacin has shown that its analgesic, anti-inflammatory and antipyretic effects are equal to those of the reference substance, indometacin. Whilst taking into consideration the contraindications mentioned in the test design, acemetacin may unhesitatingly be used for the treatment of children and adolescents at the following doses: 3-6 years 30 mg b.i.d., > 6-12 years 30 mg t.i.d., > 12 years 30 mg q.i.d.
D000293:Adolescent; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001831:Body Temperature; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004341:Drug Evaluation; D004487:Edema / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007210:Indoleacetic Acids / Q000009:adverse effects / Q000627:therapeutic use*; D007213:Indomethacin / Q000009:adverse effects / Q000627:therapeutic use* / Q000031:analogs & derivatives; D008297:Male; D010146:Pain / Q000188:drug therapy*
D000893:Anti-Inflammatory Agents; D007210:Indoleacetic Acids; C026784:acemetacin; D007213:Indomethacin
Klinische Prüfung von Acemetacin bei Kindern und Jugendlichen.