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

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

Tracking Information
First Submitted Date  ICMJE March 26, 2013
First Posted Date  ICMJE April 4, 2013
Last Update Posted Date November 1, 2023
Study Start Date  ICMJE April 2013
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2013)
Change in pain scores following administration of enema [ Time Frame: 1-2 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of Three Types of Enemas Used to Treat Functional Constipation in Children
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Functional Constipation
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 29, 2019)
40
Original Estimated Enrollment  ICMJE
 (submitted: March 30, 2013)
120
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01823848
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Current Responsible Party Ara Festekjian, Children's Hospital Los Angeles
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Children's Hospital Los Angeles
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ara Festekjian, MD CHLA Division of Emergency Medicine
PRS Account Children's Hospital Los Angeles
Verification Date October 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP