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

• ClinicalTrials.gov Identifier: NCT01823848
• Recruitment Status: Terminated
• First Posted: April 4, 2013
• Last Update Posted: November 1, 2023
• Sponsor: Children's Hospital Los Angeles
• Information provided by (Responsible Party): Ara Festekjian, Children's Hospital Los Angeles

Tracking Information

• First Submitted Date: March 26, 2013
• First Posted Date: April 4, 2013
• Last Update Posted Date: November 1, 2023
• Study Start Date: April 2013
• Actual Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 30, 2013): Change in pain scores following administration of enema [ Time Frame: 1-2 hours ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Trial of Three Types of Enemas Used to Treat Functional Constipation in Children
• Official Title: A Randomized Controlled Trial of Three Types of Enemas Used to Treat Functional Constipation in Children
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Triple (Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Functional Constipation

Intervention

• 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

Study Arms

• 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
  Interventions:

  • Drug: Sodium phosphate enema
  • Drug: Normal saline enema
  • Drug: Mineral oil enema
• 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
  Interventions:

  • Drug: Sodium phosphate enema
  • Drug: Normal saline enema
  • Drug: Mineral oil enema
• Experimental: Mineral oil enema
  Administration of mineral oil enema for functional constipation in children ages 4-12 years Administered as 66ml per rectum
  Interventions:

  • Drug: Sodium phosphate enema
  • Drug: Normal saline enema
  • Drug: Mineral oil enema

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: January 29, 2019): 40
• Original Estimated Enrollment (submitted: March 30, 2013): 120
• Actual Study Completion Date: December 2017
• Actual Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 4 Years to 12 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01823848
• Other Study ID Numbers: CCI-12-00295
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Ara Festekjian, Children's Hospital Los Angeles
• Original Responsible Party: Same as current
• Current Study Sponsor: Children's Hospital Los Angeles
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Children's Hospital Los Angeles
• Verification Date: October 2023