Efficacy and tolerability of peg-only laxative on faecal impaction and chronic constipation in children. A controlled double blind randomized study vs a standard peg-electrolyte laxative (original) (raw)
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Tolerability, Safety, and Efficacy of PEG 3350 as a 1-day Bowel Preparation in Children
Journal of Pediatric Gastroenterology & Nutrition, 2013
Objective: The aim of the study was to evaluate the tolerability, safety, and efficacy of polyethylene glycol (PEG) 3350 without electrolytes as a 1-day bowel preparation for colonoscopy in children. Methods: A prospective study of 45 children undergoing colonoscopy prescribed PEG 3350 without electrolytes mixed with a commercial electrolyte beverage was performed. Patients <45 kg received 136 g of PEG 3350 without electrolytes mixed in 32 ounces of Gatorade. Patients !45 kg were given 255 g of PEG 3350 without electrolytes in 64 ounces of Gatorade. A basic metabolic panel was performed at the time of the clinic visit and just before colonoscopy. Patients completed a survey related to bowel preparation. Endoscopists graded bowel preparation and noted the proximal extent of the examination. Results: A total of 44 patients (14 AE 3 years) completed the study. One patient was excluded due to protocol breach. All subjects reported the preparation was easy (61%) or tolerable (39%). Adverse events included nausea (34%), abdominal pain (23%), vomiting (16%), abdominal distension (20%), bloating (23%), and dizziness (7%). Although significant changes in serum glucose and CO 2 were noted, no therapeutic interventions were indicated. Significant changes in sodium, potassium chloride, blood urea nitrogen, or creatinine did not occur. Colonic preparation was rated as excellent in 23%, good in 52%, fair in 23%, and poor in 2% of patients. Intubation of the ileum was successful in 100%. Conclusions: One-day bowel preparation with high dose PEG 3350 mixed with commercial electrolyte solution is tolerable, safe, and effective in children before colonoscopy.
PEG 3350 Versus Lactulose for Treatment of Functional Constipation in Children: Randomized Study
Journal of Pediatric Gastroenterology & Nutrition, 2018
Dorota Jarzębicka: collected data, conceptualized and designed the study, designed the data collection instruments, drafted the initial manuscript, reviewed, revised and final approved the manuscript. Joanna Sieczkowska-Gołub: collected data, drafted the initial manuscript, reviewed and revised the manuscript. Jarosław Kierkuś: conceptualized and designed the study, designed the data collection instruments, coordinated and supervised data collection, and critically reviewed the manuscript Piotr Czubkowski: designed the data collection instruments, carried out the analyses, drafted the initial manuscript, reviewed and revised the manuscript. Monika Kowalczuk-Krystoń: collected data, drafted the initial manuscript, reviewed and revised the manuscript. Maciej Pelc: collected data, drafted the initial manuscript, reviewed and revised the manuscript. Dariusz Lebensztejn: conceptualized and designed the study, coordinated and supervised data collection, and critically reviewed and revised the manuscript. Bartosz Korczowski: conceptualized and designed the study, coordinated and supervised data collection, and critically reviewed the manuscript. Piotr Socha: conceptualized and designed the study, carried out the analyses, drafted the initial manuscript, reviewed and revised the manuscript. Grzegorz Oracz: conceptualized and designed the study, designed the data collection instruments, coordinated and supervised data collection, and critically reviewed the manuscript.
Archives of Disease in Childhood, 2007
Objectives: To assess the efficacy and safety of polyethylene glycol 3350 plus electrolytes (PEG+E) for the treatment of chronic constipation in children. Design: Randomised, double blind, placebo controlled crossover trial, with two 2-week treatment periods separated by a 2-week placebo washout. Setting: Six UK paediatric departments. Participants: 51 children (29 girls, 22 boys) aged 24 months to 11 years with chronic constipation (lasting >3 months), defined as (2 complete bowel movements per week and one of the following: pain on defaecation on 25% of days; >25% of bowel movements with straining; >25% of bowel movements with hard/lumpy stools. 47 children completed the double blind treatment. Main outcome measures: Number of complete defaecations per week (primary efficacy variable), total number of complete and incomplete defaecations per week, pain on defaecation, straining on defaecation, faecal incontinence, stool consistency, global assessment of treatment, adverse events and physical examination. Results: The mean number of complete defaecations per week was significantly higher for children on PEG+E than on placebo (3.12 (SD 2.05) v 1.45 (SD 1.20), respectively; p,0.001). Further significant differences in favour of PEG+E were observed for total number of defaecations per week (p = 0.003), pain on defaecation (p = 0.041), straining on defaecation (p,0.001), stool consistency (p,0.001) and percentage of hard stools (p = 0.001). Treatment related adverse events (all mild or moderate) occurred in similar numbers of children on PEG+E (41%) and placebo during treatment (45%). Conclusions: PEG+E is significantly more effective than placebo, and appears to be safe and well tolerated in the treatment of chronic constipation in children.
International Journal of Pediatrics, 2017
Background Constipation is one of the most common disorders in children. The purpose of this study was to compare paraffin and polyethylene glycol (PEG) in the treatment of children with chronic constipation. Materials and Methods This study is a double-blind randomized trial. Total 160 children aged 2-12 years old with chronic constipation attending the pediatric clinic of Mousavi Hospital in Zanjan (Iran) were examined by the same pediatric gastroenterologist. They randomly received PEG solution (1cc/kg/day divided in two doses) or paraffin at the same dose. Patients were assessed regularly once a week up to one month and then monthly until 6 months. Data were analyzed by SPSS version 16 software. Results From children enrolled in the study, 43.1% were boys with mean age 5.27±1.3 years. The male to female ratio in Paraffin and PEG groups was similar (35/45 vs. 34/46; respectively, P-value= 1.27). The mean age of the participants in paraffin group and PEG group were 5.28±1.4 and 5....
Polyethylene Glycol 4000 for Treatment of Functional Constipation in Children
Journal of Pediatric Gastroenterology & Nutrition, 2015
Objectives: The aim of the study was to evaluate the effectiveness and safety of 2 different polyethylene glycol (PEG) doses for the maintenance treatment of functional constipation in children. Methods: Children with functional constipation according to the Rome III criteria were randomly assigned to receive PEG 4000 at a dose of either 0.7 g/kg (high-dose group; n ¼ 45) or 0.3 g/kg (low-dose group; n ¼ 47) for 6 weeks. Adjustment of the therapy was recommended in the event of <3 bowel movements (BM) per week or !3 BM per day. The primary outcome measure was treatment success, defined as !3 BM per week with no fecal soiling during the last week of the intervention. Results: A total of 90 of 92 randomized children, with a mean age of 3.7 AE 2.1 years, completed the study. In the analysis based on allocated treatment, treatment success was similar in both groups (relative risk 0.9, 95% confidence interval 0.78-1.03). Compared with the high-dose PEG group, the low-dose PEG group had an increased need for therapy adjustment of borderline significance (relative risk 2.0, 95% confidence interval 1.0-4.2), an increased risk of painful defecation, a lower number of stools per week, and lower parental satisfaction. Adverse events were similar in both groups. Conclusions: To achieve treatment success, both tested doses of PEG were equally safe and effective in the treatment of children with functional constipation.
Iranian Red Crescent Medical Journal, 2016
Background: There are few effective drugs for pediatric functional constipation (FC). Objectives: Comparing the effectiveness of Cassia fistula's emulsion (CFE) with Polyethylene glycol (PEG4000) in FC; and evaluation of safety of both drugs in the treatment of FC. Materials and Methods: A randomized open label, prospective, controlled, parallel-group clinical trial was carried on 109 children (M/F: 63/46; mean age ± SD: 59.7 ± 28.8 months) in Amirkola children's hospital, Babol, Iran. The inclusion criteria were based on diagnosis of FC according to the Rome III criteria and age range between 2-15 years. They received CFE or PEG randomly for 4 weeks. Frequencies of defecation, severity of pain, consistency of stool, fecal incontinence and retentive posturing were compared between the two groups and with baselines. Children were counted as improved when they exited from Rome III criteria of FC. Results: Fifty seven patients were assigned to receive PEG and 52 patients received CFE. After 4weeks of medication, 86.5% of children in CFE group and 77.1% in PEG group (RR = 1.121, CI95%:0.939-1.338) exited from the criteria of FC. All measurable criteria improved in both groups without any significant difference, except in the frequency of defecation that in CFE group (10.96 ± 5.7) was significantly more than PEG group (6.9 ± 3.5) (P < 0.0001). Compliances of PEG were significantly better in the 2 first weeks (P = 0.002, 0.008) but not in third and fourth week (P = 0.061, 0.062). None of these two drugs cause clinically significant side effects. Conclusions: CFE can be as effective as PEG in the 4-weeks treatment of children with FC.
Journal of Research in Medical Sciences, 2012
BACKGROUND: Constipation is one of the common problems in childhood and consists of 3% of referrals to pediatricians and 25% of pediatric gastroenterologists. Aperients are common alternatives for treating chronic constipation. The present study aimed to compare the efficacy of three laxatives [polyethylene glycol (PEG), magnesium hydroxide, and lactulose]. METHODS: In this randomized clinical trial, 1 to 6 year old children with functional chronic constipation (the patients had functional chronic constipation based on ROME III criteria) were studied. 75 patients were divided into three 25 member groups through randomization method. The patients of each group received either of the polyethylene glycol, magnesium hydroxide, or lactulose medications in a standard dosage. After a month, the results were assessed and analyzed through statistical tests. RESULTS: Comparing the frequency of increased defecation in patients of the three groups also found no significant difference among them; however, mean increase of defecation frequency was higher in the magnesium hydroxide group. Compared to patients who had more than three times of defecation per week, PEG group was significantly higher than the other two groups (p < 0.05). Comparing the side effects showed that the prevalence of side effects was lower in the polyethylene glycol group than the other two groups. The patients had a significantly higher satisfaction from the taste of polyethylene glycol and lactulose (p < 0.01). CONCLUSIONS: Although the total mean of increase in defecation frequency after the treatment was higher in the magnesium hydroxide group, the indicator of defecation frequency greater than three times per week was higher in the polyethylene glycol group which indicated the success of treatment in this group. In total, comparing the therapeutic results and satisfaction of the patients, it can be concluded that polyethylene glycol can be used as one of the best alternatives to treat constipation.
Dose response of PEG 3350 for the treatment of childhood fecal impaction
The Journal of Pediatrics, 2002
Pediatric Gastroenterology, Hepatology, and Nutrition, in a recently published statement on the evaluation and treatment of childhood constipation, suggested that fecal disimpaction is beneficial before initiation of maintenance therapy. 2 Clearance of fecal material may be achieved with oral or Objective: To investigate the efficacy and safety of polyethylene glycol (PEG) 3350 in the treatment of childhood fecal impaction.