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Concept: Enema

168

BACKGROUND: PEG-based laxatives are considered today the gold standard for the treatment of constipation in children. PEG formulations differ in terms of composition of inactive ingredients which may have an impact on acceptance, compliance and adherence to treatment. We therefore compared the efficacy, tolerability, acceptance and compliance of a new PEG-only formulation compared to a reference PEG-electrolyte (PEG-EL) formulation in resolving faecal impaction and in the treatment of chronic constipation. METHODS: Children aged 2–16 years with functional chronic constipation for at least 2 months were randomized to receive PEG-only 0.7 g/kg/day in 2 divided doses or 6.9 g PEG-EL 1–4 sachets according to age for 4 weeks. Children with faecal impaction were randomized to receive PEG-only 1.5/g/kg in 2 divided doses until resolution or for 6 days or PEG-EL with an initial dose of 4 sachets and increasing 2 sachets a day until resolution or for 7 days. RESULTS: Ninety-six children were randomized into the study. Five patients withdrew consent before starting treatment. Three children discontinued treatment for refusal due to bad taste of the product (1 PEG-only, 2 PEG-EL); 1 (PEG-EL) for an adverse effect (abdominal pain). Intent-to-treat analysis was carried out in 49 children in the PEG-only group and 42 in the PEG-EL group.No significant differences were observed between the two treatment groups at baseline.Adequate relief of constipation in terms of normalized frequency and painless defecation of soft stools was achieved in all patients in both groups. The number of stools/week was 9.2 +/- 3.2 (mean +/- SD) in the PEG-only group and 7.8 +/- 2.4 in the PEG-EL group (p = 0.025); the number of days with stool was 22.4 +/- 5.1 in the PEG-only group and 19.6 +/- 7.2 in the PEG-EL group (p = 0.034).In the PEG-only group faecaloma resolution was observed in 5 children on the second day and in 2 children on the third day, while in the PEG-EL group it was observed in 2 children on the second day, in 3 children on the third day and in 1 child on the fifth day.Only 2 patients reported mild treatment-related adverse events: 1 child in the PEG-only group had diarrhoea and vomiting and 1 child in the PEG-EL group had abdominal pain requiring treatment discontinuation. The PEG-only preparation was better tolerated as shown by the lower frequency of nausea than in the PEG-EL group.In the PEG-only group, 96% of patients did not demonstrate any difficulties associated with treatment, as compared with 52% of patients in the PEG-EL group (p < 0.001). Also, the PEG-only formulation taste was better than that of PEG-EL (p < 0.001). The difference between the percentage of subjects who took > 80% of the prescribed dose was in favour of the PEG-only group (98% vs. 88%), though it did not reach a conventional statistical level (p = 0.062). CONCLUSION: PEG-only was better tolerated and accepted than PEG-EL in children with chronic constipation. At the higher PEG doses recommended by the manufactures children in the PEG-only group had higher and more regular soft stool frequency than PEG-EL.Trial registrationClinicalTrials.gov: NCT01592734.

Concepts: Randomized controlled trial, Constipation, Gastroenterology, Irritable bowel syndrome, Feces, Polyethylene glycol, Fecal impaction, Enema

28

Malone antegrade continence enemas are used in the management of neurogenic bowel to attain fecal continence. Several different irrigation solutions have been described but glycerin, an osmotic laxative that promotes peristalsis, has rarely been mentioned or studied. We assessed clinical outcomes in our patients with a Malone antegrade continence enema using glycerin based irrigation.

Concepts: Constipation, Gastroenterology, Enema, Suppository, Laxative, Laxatives

28

5-Aminosalicylic acid (5-ASA) is a first-line therapy for inducing and maintaining remission of mild and moderately active ulcerative colitis (UC). When the proximal margin of inflammation is distal to the splenic flexure, 5-ASA therapy can be delivered as a rectal suppository, foam or liquid enema.

Concepts: Ulcerative colitis, Crohn's disease, Colon, Rectum, Mesalazine, Sulfasalazine, Enema, Suppository

27

The primary aim of this study was to determine if there is a change in the quality of life in pediatric patients with unremitting functional constipation and/or encopresis after undergoing a MACE procedure.

Concepts: Life, Constipation, Enema, Mitrofanoff appendicovesicostomy, Malone antegrade continence enema

24

Rationale and key points This article aims to help nurses to undertake the administration of enemas in a safe, effective and patient-centred manner, ensuring privacy and dignity. The administration of an enema is a common healthcare procedure, which can be used to deliver medication or aid bowel evacuation. ▶ The administration of an enema should be undertaken by a competent nurse. ▶ An enema is a liquid preparation inserted into the rectum. ▶ The nurse must explain the procedure to the patient and should assist the individual before, during and after the procedure. ▶ The nurse should document all care given. Reflective activity Clinical skills articles can help update your practice and ensure it remains evidence based. Apply this article to your practice. Reflect on and write a short account of: 1. How you felt performing this intimate procedure. 2. The positive elements of care delivery and those that could be enhanced. Subscribers can upload their reflective accounts at: rcni.com/portfolio .

Concepts: Health care, Clinical trial, Constipation, Gastroenterology, Route of administration, Sigmoidoscopy, Enema, Suppository

5

The oral route is compromised for nearly all patients approaching death. When agitation, seizures, or other intractable symptoms occur, a quick, discreet, comfortable and effective alternate route for medication delivery that is easy to administer in the home setting is highly desirable.

Concepts: Pharmacology, ADME, Enema, Grammy Award for Album of the Year

3

OBJECTIVES:: Colonic dysbiosis contributes to the development of colonic inflammation in ulcerative colitis (UC). Fecal microbial transplantation (FMT) is being proposed as a novel treatment for UC as it can eliminate dysbiosis. However, no prospective data exists. We initiated a pilot study to evaluate feasibility and safety of FMT in children with UC. METHODS:: Ten children, 7 to 21 years of age, with mild to moderate UC (pediatric ulcerative colitis activity index [PUCAI] between 15 and 65) received freshly prepared fecal enemas daily for 5 days. Data on tolerability, adverse events and disease activity were collected during FMT and weekly for 4 weeks after FMT. Clinical response was defined as decrease in PUCAI by >15 and decrease in PUCAI to <10 was considered clinical remission. RESULTS:: No serious adverse events were noted. Mild (cramping, fullness, flatulence, bloating, diarrhea and blood in stool) to moderate (fever) adverse events were self-limiting. One subject could not retain fecal enemas. Average tolerated enema volume by remaining nine subjects was 165 mL/day. After FMT, seven out of the nine (78%) subjects showed clinical response within 1 week, six out of the nine (67%) subjects maintained clinical response at 1 month, and three out of the nine (33%) subjects achieved clinical remission at 1 week after FMT. Median PUCAI significantly improved after FMT (p = 0.03) compared to the baseline. CONCLUSIONS:: Fecal enemas were feasible and tolerated by children with UC. Adverse events were acceptable, self-limiting and manageable by subjects. FMT indicated efficacy in the treatment of UC.

Concepts: Ulcerative colitis, Crohn's disease, Colon, Constipation, Gastroenterology, Feces, Mesalazine, Enema

0

Oral PrEP has been approved for prophylaxis of HIV-1 transmission, but is associated with high costs and issues of adherence. Protection from anal transmission of HIV using topical microbicides using methods congruent with sexual behavior offers the promise of improved adherence. We compared the PK and ex vivo efficacy of iso-osmolar (IOsm) and hypo-osmolar (HOsm) rectal enema formulations of tenofovir (TFV) in rhesus macaques. Single-dose PK of IOsm or HOsm high (5.28mg/mL) and low (1.76mg/mL) dose formulations of TFV enemas were evaluated for systemic uptake in blood, colorectal biopsies and rectal CD4+ T cells. Markedly higher TFV concentrations were observed in plasma and tissues after administration of the HOsm high dose formulation than all others tested. TFV and TFV diphosphate (TFV-DP) concentrations in tissue correlated for the HOsm high dose formulation, demonstrating rapid uptake and transformation of TFV to TFV-DP in tissues. TFV-DP in tissues collected at 1 and 24 hours were 7x and 5x higher, respectively (p<0.01) compared to the IOsm formulation. HOsm high dose formulation was prevented infection in ex vivo challenges of rectal tissues collected at 1, 24 and 72 hours after the intrarectal dosing, whereas the same TFV dose formulated as IOsm enema was less effective.

Concepts: HIV, Blood, Macaque, Primate, Rhesus Macaque, Route of administration, Sigmoidoscopy, Enema

0

New routes of administration available for some targeted therapies, especially subcutaneous injections, have an impact not only on the patients' daycare experience, but also on the unit’s organization. This observational study conducted on 48 voluntary patients at the Institut universitaire du cancer Toulouse-Oncopole shows that the mean duration of the outpatient unit stay is diminished by one hour when a subcutaneous injection is used instead of an intravenous route. This duration decrease is mainly caused by an 82% average reduction in treatment duration. However, the waiting times before and after the treatment itself are not significantly impacted. Organizational methods related to the treatment prescription and preparation remain indeed the same. Anticipated prescription is not noticeably impacted either. This reduction of the duration of stay will truly be obtained if the whole unit’s organization is adapted.

Concepts: Pharmacology, Chemotherapy, Intravenous therapy, Arithmetic mean, Route of administration, Routes of administration, Subcutaneous injection, Enema

0

Vaginal route has been recently considered as a potential route for systemic delivery of drugs with poor oral bioavailability. Vardenafil (VDF) is a relatively new phosphodiesterase-5 inhibitor that exhibits a limited oral bioavailability (≈15%) due to extensive first-pass metabolism. In this study, we attempted to enhance the systemic bioavailability of VDF via its formulation within vaginal suppositories. Witepsol H15 and Suppocire NA50 were adopted as lipophilic suppository bases while polyethylene glycol 4000/400 and glycerogelatin were used as hydrophilic suppository bases. The effect of different base types and/or the incorporation of bioadhesive polymer on in vitro release of VDF were evaluated. The in vivo fate and organ biodistribution of VDF following intravaginal (IVG) administration were also investigated. VDF release from water-soluble bases was higher than that from lipophilic bases. The incorporation of bioadhesive polymers, such as Na alginate, remarkably sustained drug release from suppository base. The organ biodistribution study showed a higher Cmax (32 times) and AUC0-4h (20 times) of VDF in uterus following IVG administration of conventional suppositories, compared to oral administration of VDF suspension. In addition, cyclic guanosine monophosphate (cGMP) serum levels, used as an indicator of the in vivo activity of VDF, in animals were higher following IVG administration rather than oral administration. This study suggests that IVG administration of VDF might represent a potential alternative to oral route with superior therapeutic benefits especially when targeting the uterus.

Concepts: In vitro fertilisation, Biopharmaceutics Classification System, Rectum, Bioavailability, Excipient, Enema, Suppository, Laxative