Double blind randomised controlled trial of topical glyceryl trinitrate in anal fissure

Abstract

Aims-To determine the eVectiveness and safety of topical glyceryl trinitrate (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 laxatives alone for a further 10 weeks. Each week a research nurse telephoned families to assess pain scores and give advice. Main outcome measures were validated standardised pain scores and time to painless defaecation. Results-Forty subjects were recruited from 46 eligible children; 31 children completed the trial (13 in the GTN group and 18 in the placebo group). No diVerences in the proportion of those achieving pain free defaecation with relation to time were seen between the two groups. Similarly, there were no significant diVerences in pain scores between the two groups over the 16 week study period. However, in both groups pain scores had decreased significantly. There were no diVerences in the incidence of rectal bleeding, faecal 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. No serious adverse eVects were observed. Conclusions-This study suggests that 0.2% GTN paste is ineVective in the treatment of acute anal fissures in childhood. However the overall fissure healing rate is high (84%) with associated reduction in pain scores, suggesting that a nurse based treatment programme can achieve a high rate of fissure healing. (Arch Dis Child 2001;85:404-407)

Nifedipine Gel with Lidocaine in the Treatment of Anal Fissure in Children: A Pilot Study and Review of the Literature

“…Complete healing was observed in 26/31 (83.9%) after GTN, 7/14 (50%) after lidocaine, and 6/11 (35.3%) after placebo (Tander et al, 1999). Kenny et al (2001) questioned the healing power of GTN, reporting 31 children with an overall fissure healing rate of 84%, but with no differences being observed between GTN and placebo. Bacher et al (1997) conducted a randomized trial of 0.2% GTN vs. 2% lidocaine gel, each applied 3 times daily, in a mixed group of acute and chronic fissure patients.…”

Drugs Acting on the Gut: Prokinetics, Antispasmodics, Laxatives

“…However, one study comparing GTN plus oral senna and lactulose with placebo plus oral senna and lactulose, found similar response rates, with 84% healing overall [ 157 ] . Concentrations of 0.05 and 0.1% ointments were also found to be effective for fi ssure healing after 8 weeks of treatment [ 158 ] .…”

Efficacy of lanolin and bovine type I collagen in the treatment of childhood anal fissures: A prospective, randomized, controlled clinical trial

“…2 Both medical and surgical treatments are currently based on limited data extrapolated from adult experience, with few treatments for children subjected to controlled or randomized trials. 3 Despite the range of medical therapies, there has been no report on the long-term sequelae of operations for fi ssures in children, and it is not known whether the results of these techniques in children are similar. 2 Minimally invasive methods such as pneumatic or hydro- pneumatic balloon dilatation have been tried in adults, but there are no reports on the results of this treatment in children.…”

“…1 The etiology remains controversial, but chronic constipation, anodermal ischemia, and hypertonicity of the internal anal sphincter (IAS) have all been implicated. 2,3 In recent years various substances such as glycerol trinitrate, diltiazem hydrochloride, botulinum toxin, and bethanechol have all been used for the treatment of chronic anal fi ssure. [2][3][4][5][6] Lanolin ointment (Purelan) is widely used as a reepithelization agent for the prevention and treatment of sore nipples resulting from breastfeeding, whereas bovine type I collagen (Gelfi x) is used mainly to promote rapid healing of decubitus ulcers.…”