Nurko, S., Youssef, N.N., Sabri, M., Langseder, A., McGowan, J., Cleveland, M., & Di Lorenzo, C. (2008). PEG3350 in the treatment of childhood constipation: A multicenter, double-blinded, placebo-controlled trial. Journal of Pediatrics, 153, 254–261.e1.

DOI Link

Study Purpose

To determine the effect and preferred dose of polyethylene glycol 3350 (PEG3350) in children with functional constipation.

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to placebo or PEG at different doses that were identical in appearance. Dosage groups were 0.2, 0.4, or 0.8 g/kg per day. Patients took the medication for two weeks. Patients in both PEG and placebo groups also underwent behavior modification. Patients returned for evaluation after seven and 14 days of medication.

Sample Characteristics

  • The study reported on a sample of 103 healthy patients with functional constipation.
  • Mean patient age was 8.5 years (SD = 3.1).
  • The sample was 34% female.

Setting

  • Multi-site
  • Outpatient
  • United States

Phase of Care and Clinical Applications

The study has clinical applicability for pediatrics.

Study Design

This was a double-blind, placebo-controlled, prospective, randomized study.

Measurement Instruments/Methods

  • Diary (parents)
  • Physical examination
  • Laboratory (chemistry, serum osmolarity, and liver function tests)
  • Printed calendars (pediatrics with stickers)

Results

  • More patients taking PEG had bowel movements compared with the placebo group (p = 0.026), but no difference existed among the PEG dose groups in terms of one dose being better than another.
  • Patients in the PEG groups had more stools than those in the placebo group (p = 0.017).
  • Response rates were not significantly different between children aged younger than 8 or older than 8.
  • Patients in the PEG groups had other benefits such as improved stool consistency and less straining.
  • The treatment was well tolerated.

Conclusions

PEG is a well-tolerated, effective treatment for chronic constipation in healthy children.

Limitations

  • The study only lasted for two weeks.
  • A behavioral modification given as part of the collection process in which children received positive and negative reinforcement could have influenced the results.
  • The sample was healthy children; application in children with cancer is not clear.

Nursing Implications

This well-done study demonstrated the usefulness of PEG in the management of constipation for healthy children. PEG may be useful for children with cancer, but this specific application has not been studied.