Efficacy of nitroglycerine ointment in the treatment of pediatric anal fissure



      Anal fissure is the most common anal disease in children. In the past few decades, the understanding of its pathophysiology has led to a progressive reduction in invasive procedures in favor of conservative treatment based on stool softeners and the relaxation of the anal sphincter. This randomized controlled study assessed the safety and efficacy of nitroglycerine (NTG) ointment in the treatment of pediatric anal fissure, which had not yet been proved.

      Patients and methods

      An unequal randomized controlled study included 105 pediatric patients with anal fissure who had presented to the private and outpatient clinics of the Central Teaching Hospital of Pediatrics during the period from February 2015 to May 2016. The control group consisted of 70 patients. Both groups were treated with classical conservative therapy of sitz bath, stool softener, and local anesthetic. In the second group, chemical sphincterotomy with 0.2% NTG ointment was used in 35 patients, and was applied at the anal canal twice daily for 8 weeks. The primary outcomes of symptomatic improvement and healed fissure, as well as side effects, were analyzed.


      The average age of patients was 2 years (range, 4 months to 5 years). Patients in the NTG group had 77% symptomatic relief and 60% healed fissure compared to the control group, which had 54% and 32.8% respectively. All were statistically significant. No serious adverse effects were noticed during the treatment period.


      The use of 0.2% NTG ointment is an effective therapy for anal fissure in children in terms of good healing rate and rapid symptom relief, but it has the drawback of a long treatment period, making patient compliance more difficult, in addition to the problems of tolerance and recurrence.

      Type of study

      Prospective randomized controlled study (treatment study).

      Level of evidence

      Type 2.

      Key words

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to Journal of Pediatric Surgery
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Rintala Risto J.
        • Mikko P.
        Other disorders of the anus and rectum, anorectal function.
        in: Coran Arnold G. Pediatric surgery. 7th ed. Elsevier Saunders, Philadelphia2012: 1311-1320
        • Schlichtemeier S.
        • Engel A.
        Anal fissure.
        Austr Prescriber. 2016; 39: 14-17
        • Dykes S.L.
        • Madoff R.D.
        Benign anorectal: Anal fissure.
        in: Wolff B.G. Fleshman J.W. Beck D.E. Pemberton J.H. Wexner S.D. The ASCRS textbook of colon and rectal surgery. Springer Science + Business Media, LLC, New York, NY2007: 178-191
        • Kenny S.E.
        • Irvine T.
        • Driver C.P.
        • et al.
        Double blind randomised control trial of topical glyceryl trinitrate in anal fissure.
        Arch Dis Child. 2001; 85: 404-407
        • Hashimoto S.
        • Kobayashi A.
        Clinical pharmacokinetics and pharmacodynamics of glyceryl trinitrate and its metabolites.
        Clin Pharmacokinet. 2003; 42: 205-221
        • Srouji Rasha
        • Ratnapalan Savithiri
        • Schneeweiss Suzan
        Pain in children: assessment and non-pharmacological management.
        Int J Pediatr. 2010; ([PMC free article, PubMed]): 474838
        • Elser J.M.
        • Woody R.C.
        Migraine headache in the infant and young child.
        Headache. 1990; 30: 366-368
        • Yiannakopoulou Eugenia
        Botulinum toxin and anal fissure: efficacy and safety systematic review.
        Int J Colorectal Dis. 2012; 27: 1-9
        • Fenton Caroline
        • Wellington Keri
        • Easthope Stephanie E.
        0.4% nitroglycerin ointment in the treatment of chronic anal fissure pain.
        Drugs. 2006; 66: 343-349
      1. Chronic anal fissure: 0.2% topical glyceryl trinitrate ointment.
        National Institute for Health and Excellence, 2013 ([, accessed 16.08.12])
        • Sonmez K.
        • Demmirogullan B.
        • Ekingen G.
        • et al.
        Randomized placebo controlled treatment of anal fissure by lidocaine, EMLA and GTN in children.
        J Pediatr Surg. 2002; 37: 1313-1316
        • Altomare D.F.
        • Binda G.A.
        • Canuti S.
        • et al.
        The management of patients with primary chronic anal fissure: a position paper.
        Tech Coloproctol. 2011; 15: 135-141
        • Zghair Luai Farhan
        • Atra Ammar Ali
        • Hasan Jamal Abdel
        Glyceryl trinitrate treatment in chronic fissure in ano.
        Iraqi Med J. 2016; 62: 51-55
        • Madalinski Mariusz Henryk
        Current understanding of anal fissure pathophysiology.
        in: Anninos Photios Rossi Marco Pham Tuan D. Falugi Carla Bussing Arndt Koukkou Martha Advances in biomedical research. WSEAS Press, University of Cambridge, UK2010: 498-502
        • Kilincaslan H.
        • Abali O.
        • Demirkaya S.K.
        • et al.
        Clinical, psychological and maternal characteristics in early functional constipation.
        Pediatr Int. 2014; 56: 588-593
        • Orsay C.
        • Rakinic J.
        • Perry Brian W.
        • et al.
        Practical parameters for the management of anal fissures.
        Dis Colon rectum. 2007; 47: 2003-2007
        • Thornton M.J.
        • Kennedy M.L.
        • King D.W.
        Prospective manometric assessment of botulinum toxin and its correlation with healing of chronic anal fissure.
        Dis Colon rectum. 2005; 48: 1424-1431
        • Gil J.
        • Luján J.
        • Hernández Q.
        • et al.
        Screening for the effectiveness of conservative treatment in chronic anal fissure patients using anorectal manometry.
        Int J Colorectal Dis. 2010; 25: 649-654
      2. Rectogesic® 4 mg/g rectal ointment; ProStrakan, the electronic medicines compendium.
        ([Manufacturer's last updated on eMC 2016 Jul 11 accessed 16.08.15])
        • Demirbag S.
        • Tander B.
        • Atabek C.
        • et al.
        Long-term results of topical glyceryl trinitrate ointment in children with anal fissure.
        Ann Trop Paediatr. 2005; 25: 135-137
        • Bansal A.R.
        • Yadav Pawan Kumar
        • Godara Rajesh
        • et al.
        Comparative evaluation of 0.2% glyceryl trinitrate vs. 2% diltiazem ointment in treatment of chronic anal fissure: a case trial.
        Hell J Surg. 2016; 88: 25-30
        • Pérez-Legaz J.
        • Arroyo A.
        • Moya P.
        • et al.
        Perianal versus endoanal application of glyceryl trinitrate 0.4% ointment in the treatment of chronic anal fissure: results of a randomized control trial. Is this the solution to the headaches?.
        Dis Colon rectum. 2012; 55: 893-899
        • Farouk Ridzuan
        Sphincter-preserving therapy for treating a chronic anal fissure: long-term outcomes.
        Ann Coloproctol. 2014; 30: 132-134
        • Cundall J.D.
        • Gunn J.
        • Easterbrook J.R.
        • et al.
        The dose response of the internal anal sphincter to topical application of glyceryl trinitrate ointment.
        Colorectal Dis. 2001; 3: 259-262