A prospective, double-blind, randomized, placebo-controlled trial comparing the efficacy of polyethylene glycol versus polyethylene glycol combined with topical diltiazem for treating anal fissure in children

Alshehri, Abdullah; Barghouthi, Rakan; Albanyan, Saleh; Alayed, Maria; Alsubaie, Hadeel; Alhayyan, Rawan M.; Alzahem, Abdullah; Altokhais, Tariq; Albassam, A.A.; Al‐Jazaeri, Ayman

doi:10.1016/j.jpedsurg.2020.01.010

Cited by 5 publications

(4 citation statements)

References 23 publications

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“…The power analysis for this study was based on a 40% difference between both groups. 17 There is a potential risk for type-II errors in this study, but it showed that treatment of constipation, with for instance polyethylene glycol, is important in children with anal fissure. Painful defecation decreased from 96 to 8% after 12 weeks in the group treated with polyethylene glycol and placebo.…”

Section: Calcium Channel Blockersmentioning

confidence: 68%

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Anal Fissure in Children

Patkova

Wester

2020

Eur J Pediatr Surg

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Anal fissure is a common clinical problem in children and is defined as a longitudinal tear in the anal canal. The typical presentation is painful defecation and rectal bleeding. The etiology of anal fissure is unknown, but passage of hard stools and increased internal anal sphincter pressure are considered important factors. The treatment is oriented to relieve the spasm of the internal anal sphincter, which prevents healing of the fissure. Conservative management with stool softeners, topical analgesics, and sitz baths is recommended as first-choice therapy. Surgical treatment has been replaced by nonoperative management as definitive therapy, which is associated with a marginally higher success rate than placebo. Most recent studies have focused on nonoperative treatment with glyceryl trinitrate, calcium channel blockers, or botulinum toxin injection treatment. There are a few controlled studies to compare the different nonoperative treatment options in children. Success rates vary between the studies, and there is no clear evidence about which is the optimal nonoperative treatment. A significant recurrence rate has been reported after nonoperative management of anal fissure. It is important to treat constipation to avoid recurrent tears in the anal canal.

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Section: Calcium Channel Blockersmentioning

confidence: 68%

“…Interestingly, only 46 and 38% of the children in diltiazem and placebo group, respectively, were taking polyethylene glycol at 12 weeks. 17…”

Section: Calcium Channel Blockersmentioning

confidence: 99%

Anal Fissure in Children

Patkova

Wester

2020

Eur J Pediatr Surg

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“…Joda and Al‐Mayoof [64] reported that 0.2% GTN showed better healing rates compared with standard treatment (which included local anaesthetic). Regarding diltiazem, a further RCT found no additional benefit to 2% diltiazem over standard treatment [65].…”

Section: Resultsmentioning

confidence: 99%

The Association of Coloproctology of Great Britain and Ireland guideline on the management of anal fissure

Cross,

Brown,

Kleijnen

et al. 2023

Colorectal Disease

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AimThe management of anal fissure: ACPGBI position statement was written 15 years ago. [KLR Cross et al., Colorectal Dis, 2008]. Our aim was to update the guideline and provide recommendations on the most effective treatment for patients with anal fissures utilising a multidisciplinary, rigorous guideline methodology.MethodsThe development process consisted of six phases. In phase 1 we defined the scope of the guideline. The patient population included patients with acute and chronic anal fissure. The target group was all practitioners (primary and secondary care) treating patients with fissures and, in addition, healthcare workers and patients who desired information regarding fissure management. In phase 2 we formed a guideline development group (GDG) including a methodologist. In phase 3 review questions were formulated, using a reversed PICO process, starting with possible recommendations based on the GDG's knowledge. In phase 4 a comprehensive literature search focused on existing systematic reviews addressing each review question, supplemented by more recent studies if appropriate. In phase 5 data were extracted from the included papers and checked by the GDG. If indicated, meta‐analysis of systematic review data was updated by the GDG. During phase 6 the GDG members decided what recommendations could be made based on the evidence in the literature and strength of the recommendation was assessed using ‘grade’.ResultsThis guideline is divided into two sections: Primary care which includes (i) diagnosis; (ii) basic treatment; (iii) topical treatment; and secondary care which includes (iv) botulinum toxin therapy; (v) surgical intervention and (vi) special situations (including pregnancy and breast‐feeding patients, children, receptive anal intercourse and low‐pressure fissures). A total of 23 recommendations were formulated. A new term clinically healed was described by the GDG.ConclusionThis guideline provides an up‐to‐date evidence‐based summary of the current knowledge of the management of anal fissure and may serve as a useful guide for clinicians as well as a potential reference for patients.

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“…In addition, it skips hepatic first-pass metabolism considering that the active molecules could be absorbed through systemic circulation 44 . According to a study, anal fissure treatment in children can be benefited by the topical administration of poly(ethylene glycol) and diltiazem 45 .…”

Section: Introductionmentioning

confidence: 99%

Current Status of Pediatric Formulations for Chronic and Acute Children’ Diseases: Applications and Future Perspectives

Sıafaka

Ipekci

Çağlar

et al. 2021

MMJ

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Infants and other children can be affected by various acute, chronic and many of them rare illnesses. Developing drugs for children is very challenging since they cannot intake tablets or hard oral solid dosage forms. Besides, most of the prescribed pediatric medications are unlicensed. The biggest issue that clinicians have to solve is that dosing in children is not based on weight or surface area of the body, as it happened in adults but is related to age variations in drug absorption, distribution, metabolism, and elimination. Thus, for pediatric patients, various therapeutic approaches have been proposed so as to develop suitable formulations such as liquid dosage forms, flexible capsules, milk-based products, etc. In addition, the administration of current pharmaceutical products to children might lead to some serious side effects which can also happen in adults but with a lower risk. Especially, infants are at high risk of getting poisoned by taking drugs used for adults. Moreover, children are very sensitive to the taste and smell of some pharmaceutical vehicles and can resist to intake them and this situation leads parents to search for tasteless and odorless medications. In this study, the current formulations for various diseases intended to be used in pediatric patients as well as various chronic and acute diseases of childhood are summarized. Authors believe that this review can help professionals who want to work with pediatric formulations to design more efficient and child-friendly drug delivery systems.

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A prospective, double-blind, randomized, placebo-controlled trial comparing the efficacy of polyethylene glycol versus polyethylene glycol combined with topical diltiazem for treating anal fissure in children

Cited by 5 publications

References 23 publications

Anal Fissure in Children

Anal Fissure in Children

The Association of Coloproctology of Great Britain and Ireland guideline on the management of anal fissure

Current Status of Pediatric Formulations for Chronic and Acute Children’ Diseases: Applications and Future Perspectives

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