Healthy Poos in ED - The efficacy of different sets of instructions for Polyethylene glycol and electrolytes administration for the treatment of constipation in children presenting to the emergency department.

Healthy Poos in ED Study (A): A randomised controlled trial of instructions for taking Polyethylene glycol + electrolytes in the treatment of faecal impaction in children aged 4 to 18 years presenting to an emergency department.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000561482

Enrollment

400

Registered

2016-05-02

Start date

2016-04-26

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A randomised controlled trial of instructions for taking Polyethylene glycol + electrolytes (PEG+E) in the treatment of faecal impaction in children aged 4 to 18 years presenting to an emergency department (ED). This study aims to compare effectiveness of two different sets of instructions provided with PEG+E for paediatric faecal impaction treatment in an ED. This is a single-centre, prospective, randomised controlled trial of two instructions (standard instructions vs. extended instructions) provided in both written and video for the intake of PEG+E treatment. Primary: Main symptom improvement, remission from the inclusion criteria at day 6 post study treatment initialization as rated by the participant or his/her guardian. Secondary: stool frequency/consistency/ease of stool passage and stool volume (questionnaires)

Interventions

The extended instructions provide information on how much medication to take, about tips on healthy toileting practices, how the medication works and its mode of action in simple language. The format of the instructions is in written hard copy fact sheets also with a URL link to a visual version of the same information The instructions are administered to the relative to at discharge in a sealed envelope (double blinded) The extended instructions include 1 extra page in the hard copy and 6 extra minutes in the electronic version. Total anticipated time to take approximately 9 minutes to view video and 5 minutes to read paper fact sheet completely, total 14 minutes. These instructions are provided to parent of child and child.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Educational / counselling / training

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

4 Years to 18 Years

Healthy volunteers

Inclusion criteria

1. presented to Emergency Department with a principal diagnosis of constipation (must meet Rome 3 criteria for constipation) 2. Is able to receive treatment at home 3. Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant’s behalf 4. Is able to access internet at home to view the video

Exclusion criteria

known sensitivity to PEG

Outcome results