Double blind randomised controlled trial of topical glyceryl trinitrate inanal fissure

Aims-To determine the effectiveness and safety of topical glyceryl trinitra te (GTN) in the management of acute anal fissure in children. Methods-Individual children were randomised to receive GTN paste or placebo for six weeks in addition to oral senna and lactulose. Patients took laxat ives alone for a further 10 weeks. Each week a research nurse telephoned fa milies to assess pain scores and give advice. Main outcome measures were va lidated standardised pain scores and time to painless defaecation. Results-Forty subjects were recruited from 46 eligible children; 31 childre n completed the trial (13 in the GTN group and 18 in the placebo group). No differences in the proportion of those achieving pain free defaecation wit h relation to time were seen between the two groups. Similarly, there were no significant differences in pain scores between the two groups over the 1 6 week study period. However, in both groups pain scores had decreased sign ificantly. There were no differences in the incidence of rectal bleeding, f aecal soiling, presence of visible fissure, skin tag, or faecal loading at outpatient review at the time of recruitment, or at 6 weeks and 16 weeks. N o serious adverse effects were observed. Conclusions-This study suggests that 0.2% GTN paste is ineffective in the t reatment of acute anal fissures in childhood. However the overall fissure h ealing rate is high (84%) with associated reduction in pain scores, suggest ing that a nurse based treatment programme can achieve a high rate of fissu re healing.