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

NCT01823848 | Terminated

• 1 other identifier: CCI-12-00295
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Constipation

Keywords

constipation; enema

Outcome Measures

Primary Outcomes (1)

• Change in pain scores following administration of enema

  1-2 hours

Study Arms (3)

Sodium phosphate enema

ACTIVE COMPARATOR

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; Drug: Normal saline enema; Drug: Mineral oil enema

Normal saline enema

ACTIVE COMPARATOR

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; Drug: Normal saline enema; Drug: Mineral oil enema

Mineral oil enema

EXPERIMENTAL

Administration of mineral oil enema for functional constipation in children ages 4-12 years Administered as 66ml per rectum

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

Interventions

Sodium phosphate enema DRUG

Rectally administered medication to treat constipation

Also known as: Fleets enema

Mineral oil enema; Normal saline enema; Sodium phosphate enema

Normal saline enema DRUG

Rectally administered medication to treat constipation

Mineral oil enema; Normal saline enema; Sodium phosphate enema

Mineral oil enema DRUG

Mineral oil enema administered to treat constipation. 66ml per rectum

Mineral oil enema; Normal saline enema; Sodium phosphate enema

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ara Festekjian, MD

  CHLA Division of Emergency Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Pediatrics

Study Record Dates

• First Submitted: March 26, 2013
• First Posted: April 4, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)