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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by Children's Hospital Los Angeles
Sponsor:
Information provided by (Responsible Party):
Ara Festekjian, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier:
NCT01823848
First received: March 26, 2013
Last updated: March 30, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Functional Constipation
Drug: Sodium phosphate enema
Drug: Normal saline enema
Drug: Mineral oil enema

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Three Types of Enemas Used to Treat Functional Constipation in Children

Resource links provided by NLM:


Further study details as provided by Children's Hospital Los Angeles:

Primary Outcome Measures:
  • Change in pain scores following administration of enema [ Time Frame: 1-2 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: April 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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

  Eligibility

Ages Eligible for Study:   4 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01823848

Contacts
Contact: Ara Festekjian, MD 3233612109 afestekjian@chla.usc.edu

Sponsors and Collaborators
Children's Hospital Los Angeles
Investigators
Principal Investigator: Ara Festekjian, MD CHLA Division of Emergency Medicine
  More Information

No publications provided

Responsible Party: Ara Festekjian, Assistant Professor of Clinical Pediatrics, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT01823848     History of Changes
Other Study ID Numbers: Enema Randomization
Study First Received: March 26, 2013
Last Updated: March 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Los Angeles:
constipation
enema

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Mineral Oil
Emollients
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014