A Trial of Three Types of Enemas Used to Treat Functional Constipation in Children

October 30, 2023 updated by: Ara Festekjian, Children's Hospital Los Angeles

A Randomized Controlled Trial of Three Types of Enemas Used to Treat Functional Constipation in Children

Functional constipation is extremely common in children and is defined as painful, hard stools or firm stools for twice or less per week. Functional constipation accounts for 3% of general pediatric visits and up to 25% of pediatric gastroenterology visits. Constipation and fecal impaction can lead to a range of symptoms including decreased appetite, vomiting, and abdominal pain frequently resulting in Emergency Department (ED) presentation. In contrast to the outpatient setting where diet and oral medications work well to relieve symptoms related to functional constipation, ED management requires an approach with quicker results. For immediate relief of symptoms, disimpaction via enema use may be better than polyethylene glycol (PEG) 3350 for children. However, the type of enema to be used is not well studied. Currently, any patient presenting to the ED with a presumed diagnosis of abdominal pain due to functional constipation receives an oral dose of PEG and one of the following three types of enemas (based on the ED treating attending's discretion): phosphate or Fleets enema, normal saline enema, or mineral oil enema. There is no evidence in the literature that demonstrates any difference in the effectiveness of each of these enemas. The investigators propose a randomized control trial of the three types of pediatric enemas readily used in our ED to determine the best approach. There will be three arms within this study: a) PEG plus phosphate enema b) PEG plus normal saline enema and c) PEG plus mineral oil enema. The physicians enrolling patients will not be the treating physicians. The four principal investigators (blinded to the type of enema being used), following appropriate informed consent, will obtain pain scores (Faces Pain Scale - Revised) pre- and post-administration of each of the three treatments listed above in order to determine the best enema to use in children 4-12 years of age. Other outcomes to be analyzed will include the patient's weight pre- and post-administration of the enema, satisfaction ratings on a visual analog scale from the treating physician (who will also be blinded), and parental surveys on the day of administration and 3-5 days following discharge. Data analysis for pain scores will be completed with repeated measures anova. Categorical values will be compared using Chi Square analysis and continuous variables will be compared using parametric statistics.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 4-12 years
  • Receiving enema in ED for presumed constipation

Exclusion Criteria:

  • Critically ill patient
  • Any history of renal insufficiency, renal disease, or elevated creatinine
  • Any history of intestinal anatomic abnormality (i.e. anal stenosis, anal surgery, bowel obstruction, hirschprung's disease)
  • An inability to self-report pain
  • Presence of gastrostomy or jejunostomy tube
  • Any history of gastrointestinal dysmotility
  • Inability to read or speak English or Spanish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sodium phosphate enema
Administration of sodium phosphate (fleets) enema for functional constipation in children ages 4-12 years Age 4-5: 33ml per rectum Age 5-12: 66ml per rectum
Drug: Sodium phosphate enema
Rectally administered medication to treat constipation
Other Names:
  • Fleets enema
Drug: Normal saline enema
Rectally administered medication to treat constipation
Drug: Mineral oil enema
Mineral oil enema administered to treat constipation. 66ml per rectum
Active Comparator: Normal saline enema
Administration of normal saline enema for functional constipation in children ages 4-12 years Admininstered as 10ml/kg with maximum of 700ml
Drug: Sodium phosphate enema
Rectally administered medication to treat constipation
Other Names:
  • Fleets enema
Drug: Normal saline enema
Rectally administered medication to treat constipation
Drug: Mineral oil enema
Mineral oil enema administered to treat constipation. 66ml per rectum
Experimental: Mineral oil enema
Administration of mineral oil enema for functional constipation in children ages 4-12 years Administered as 66ml per rectum
Drug: Sodium phosphate enema
Rectally administered medication to treat constipation
Other Names:
  • Fleets enema
Drug: Normal saline enema
Rectally administered medication to treat constipation
Drug: Mineral oil enema
Mineral oil enema administered to treat constipation. 66ml per rectum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in pain scores following administration of enema
Time Frame: 1-2 hours
1-2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Los Angeles

Investigators

  • Principal Investigator: Ara Festekjian, MD, CHLA Division of Emergency Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

March 26, 2013

First Submitted That Met QC Criteria

March 30, 2013

First Posted (Estimated)

April 4, 2013

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCI-12-00295

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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