What is the evidence for clinical use of gastrografin enema? What are procedures and precautions for preparation and administration?

What is the evidence for clinical use of gastrografin enema? What are procedures and precautions for preparation and administration? - Full Literature Search Request

Comment by InpharmD Researcher

Gastrografin enema has been used for radiographic evaluation of the gastrointestinal tract and for management of intestinal obstruction or meconium-related ileus (Tables 1-6). In both pediatric and adult populations, dilution ratios and dosing strategies vary widely, and no standardized dosing regimen has been established. One prospective trial evaluated Gastrografin in severe chronic constipation (Table 1); however, the agent was administered orally rather than as an enema. According to the prescribing information, oral Gastrografin (diatrizoate meglumine and diatrizoate sodium) may be administered undiluted in adults, with typical doses ranging from 30 to 90 mL depending on the examination and patient size. In pediatric patients, doses are commonly diluted 1:1 with water, carbonated beverage, milk, or mineral oil. In very young or debilitated children weighing less than 10 kg, a greater dilution of 1 part Gastrografin to 3 parts water is recommended. When administered as an enema or enterostomy instillation, Gastrografin should always be diluted. For adults, an example dilution is 240 mL Gastrografin in 1,000 mL tap water. Similarly, dilute solutions are recommended for tomography or other body imaging studies. Administration of undiluted Gastrografin, particularly in patients with bowel overdistension or when given in large volumes, may increase the risk of mucosal irritation.

Background

A 2017 article explored the gastrointestinal manifestations in patients with Cystic Fibrosis. Sodium meglumine diatrizoate (Gastrografin) is a hypertonic radio-opaque contrast medium that has proven effective in alleviating episodes of acute Distal Intestinal Obstruction Syndrome (DIOS) when administered either orally or via enema. Despite its efficacy, oral administration is not without risks, as it can occasionally lead to serious complications like hypovolemic shock caused by rapid fluid shifts, necrotizing enterocolitis in neonates, and bowel perforation. However, in the hands of an experienced medical team, the use of a therapeutic enema with diluted Gastrografin, where the solution is rectally instilled and the terminal ileum is visualized, has shown success in both children and adults with cystic fibrosis (CF). In such cases, this approach can potentially serve as a preferred first-line therapy, either before or after polyethylene glycol (PEG) lavage, once a diagnosis of acute partial or complete DIOS necessitating urgent hospitalization has been confirmed. [1]

Relevant Prescribing Information

Indications and Usage [2]:
Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution) is indicated for radiographic examination of segments of the gastrointestinal tract (esophagus, stomach, proximal small intestine, and colon). The preparation is particularly indicated when a more viscous agent such as barium sulfate, which is not water-soluble, is not feasible or is potentially dangerous.

Gastrografin may also be used as an adjunct to contrast enhancement in computed tomography of the torso (body imaging); the preparation is indicated, in conjunction with intravenous administration of a radiopaque contrast agent, when unenhanced imaging may not provide sufficient definition in distinguishing normal loops of bowel from adjacent organs or areas of suspected pathology.

Dosage and Administration:
Radiographic Examination of Segments of the Gastrointestinal Tract
Oral Administration: Adult oral dosage may range from 30 to 90 mL (11 to 33 g iodine), depending on the nature of the examination and the size of the patient. For infants and children less than 5 years of age, 30 mL (11 g iodine) are usually adequate; for children 5 to 10 years of age, the suggested dose is 60 mL (22 g iodine). These pediatric doses may be diluted 1:1, if desired, with water, carbonated beverage, milk, or mineral oil. When used in infants, the solution may be given in a nursing bottle. Pediatric doses may also be used in dehydrated and/or debilitated adult patients. A 1:1 dilution is also recommended when the contrast medium is used in elderly cachectic individuals.

For very young (under 10 kg) and debilitated children the dose should be diluted: 1 part Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution) in 3 parts water is recommended.

For Enemas or Enterostomy Instillations: Gastrografin should be diluted when it is used for enemas and enterostomy instillations. When used as an enema, the suggested dilution for adults is 240 mL (88 g iodine) in 1,000 mL of tap water. For children under 5 years of age, a 1:5 dilution in tap water is suggested; for children over 5 years of age, 90 mL (33 g iodine) in 500 mL of tap water is a suitable dilution.

Tomography (Body Imaging)
A usual adult dose is 240 mL of a dilute Gastrografin solution prepared by diluting 25 mL (9.17 g iodine) to one liter with tap water. Less dilute solutions [up to 77 mL (28.26 g iodine) diluted to one liter with tap water] may be used when indicated. The dose is administered orally about 15 to 30 minutes prior to imaging in order to permit the contrast medium to reach the pelvic loops.

Clinical pharmacology:
Diatrizoate meglumine and diatrizoate sodium are sparingly absorbed from the intact gastrointestinal tract, and therefore permit gastrointestinal opacification and delineation after oral or rectal administration. Oral administration is used for radiographic evaluation of the esophagus, stomach and proximal small intestine. Rectal administration is used for examination of the colon; however, visualization of the distal small bowel is generally unsatisfactory, since the hypertonicity of the medium causes intraluminal diffusion of water with subsequent dilution of the medium. Enough absorption from the gastrointestinal tract to permit incidental visualization of the urinary tract has been reported; this should also be considered when thyroid testing is being contemplated, since iodine-mediated thyrotropic effects may occur.

DOSAGE AND ADMINISTRATION
Radiographic Examination of Segments of the Gastrointestinal Tract
-Oral Administration: Adult oral dosage may range from 30 to 90 mL (11 to 33 g iodine), depending on the nature of the examination and the size of the patient. For infants and children less than 5 years of age, 30 mL (11 g iodine) are usually adequate; for children 5 to 10 years of age, the suggested dose is 60 mL (22 g iodine). These pediatric doses may be diluted 1:1, if desired, with water, carbonated beverage, milk, or mineral oil. When used in infants, the solution may be given in a nursing bottle. Pediatric doses may also be used in dehydrated and/or debilitated adult patients. A 1:1 dilution is also recommended when the contrast medium is used in elderly cachectic individuals. For very young (under 10 kg) and debilitated children the dose should be diluted: 1 part Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution) in 3 parts water is recommended.

-For Enemas or Enterostomy Instillations:
Gastrografin should be diluted when it is used for enemas and enterostomy instillations. When used as an enema, the suggested dilution for adults is 240 mL (88 g iodine) in 1,000 mL of tap water. For children under 5 years of age, a 1:5 dilution in tap water is suggested; for children over 5 years of age, 90 mL (33 g iodine) in 500 mL of tap water is a suitable dilution.

PRECAUTIONS
Rectal administration of undiluted Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution) in any patient, particularly with large doses and/or in those with overdistention, has been reported to be associated with mucosal irritation.

Pediatric Use
Local injury to the colonic mucosa, particularly in the presence of underlying disease which interferes with intestinal viability, has been reported in cases where recommended doses and dilutions were not used.

Literature Review

A search of the published medical literature revealed 6 studies investigating the researchable question:

What is the evidence for clinical use of gastrografin enema? What are procedures and precautions for preparation and administration? - Full Literature Search Request

Level of evidence

C - Multiple studies with limitations or conflicting results Read more→

Please see Tables 1-6 for your response.

Gastrografin Enemas for Treatment of Distal Intestinal Obstruction Syndrome in Children and Adults with Cystic Fibrosis
Design	Case series N= 8 subjects (12 enemas)
Objective	To describe the technique, volume, and results of Gastrografin enema usage for distal intestinal obstruction syndrome (DIOS) in children and adults with cystic fibrosis
Study Groups	All subjects (N= 8)
Inclusion Criteria	Patients with cystic fibrosis treated for DIOS with Gastrografin enemas between 2006 and 2011
Exclusion Criteria	Not explicitly stated
Methods	Patients were admitted and given intravenous hydration. Abdominal radiograph and/or CT scan were performed before enemas. The Gastrografin enema is performed inpatient with intravenous fluids to prevent fluid shifts. A diluted solution (500-1000 ml, 1:4 ratio with tap water) is administered to fill the colon and attempt reflux into the distal small bowel, typically using 20-50 ml/kg. The procedure is done under hydrostatic pressure with fluoroscopic monitoring, and enemas may be repeated after 16-24 hours if clinically indicated.
Duration	2006 to 2011
Outcome Measures	Resolution of DIOS episodes
Baseline Characteristics		All subjects (N= 8)
	Age, years (range)	22.25 (2 to 49)
	Female	2
Results	Endpoint	All subjects (n= 8 enemas)
	Volume of diluted Gastrografin used (range)	1220 ml or 31 ml/kg (240 to 3500 ml; 19 to 59 ml/kg)
	Three patients had incomplete resolution and required repeat enemas despite reflux into the terminal ileum, with two receiving a second enema the next day and one undergoing three consecutive days of treatment. One patient experienced a second acute DIOS episode, requiring a Gastrografin enema 6 months after the initial treatment.
Adverse Events	All patients were treated without complications and discharged after DIOS resolution.
Study Author Conclusions	Large volume radio-opaque hypertonic enemas can resolve episodes of acute DIOS and can be repeated on subsequent days if needed, without complications. The incidence of DIOS reported to the United States CF Foundation Patient Registry has increased in both children and adults over the past decade.
InpharmD Researcher Critique	The study provides valuable insights into the use of Gastrografin enemas for DIOS but is limited by its retrospective nature and small sample size. Prospective, randomized trials would be beneficial to further validate findings.

References:
[1] [1] Mahmoud Zahra, Frederick C, Thomas R, Iqbal V, Borowitz D. Gastrografin enemas for treatment of distal intestinal obstruction syndrome in children and adults with cystic fibrosis. J Pharm Nutr Sci. 2014;4(2):76-80.

Use of gastrografin in the management of faecal impaction in patients with severe chronic constipation: a randomized clinical trial
Design	Double-blinded, controlled, and randomized clinical trial N= 83
Objective	To evaluate the efficacy of enteral administration of gastrografin compared to enema in the treatment of faecal impaction in patients with severe chronic constipation
Study Groups	Gastrografin group (received through nasojejunal tube; n= 41) Enema group (n= 42)
Inclusion Criteria	Patients aged 16-65 years with confirmed faecal impaction, fulfilling Rome III criteria for chronic constipation present for ≥8 weeks
Exclusion Criteria	History of colorectal surgery, organic cause of constipation, pregnancy, long-term conditions associated with constipation, medical or psychiatric illness, abnormal laboratory data or thyroid function
Methods	After faecal impaction diagnosis, patients were randomly assigned to the gastrografin or enema group. The gastrografin group received 100 mL of undiluted gastrografin (100 mg sodium diatrizoate and 660 mg meglumine diatrizoate per mL) via nasojejunal tube daily for six days, followed by a 2-hour clamp. The enema group received 133 mL of sodium phosphates rectal solution daily for six days (containing 19 g monobasic sodium phosphate, 7 g dibasic sodium phosphate, and 4.4 g sodium per 118 mL).
Duration	April 2015 to September 2016 Treatment: Six consecutive days
Outcome Measures	Successful faecal disimpaction and duration of faecaloma resolution
Baseline Characteristics	Characteristic	All subjects (N= 83)
	Age, years	44 ± 15.8
	Female	72.29%
Results	Outcome	Gastrografin group (n= 41)	Enema group (n= 42)
	Successful Disimpaction	31 (88.57%)	25 (69.44%)
	Mean Duration of Impaction, hours	30.17 ± 14.32	66 ± 23.49
Adverse Events	Gastrografin group: abdominal pain (6), nausea/vomiting (7), lightheadedness (3). Enema group: abdominal pain (9), nausea (2), fatigue (1). No significant difference in adverse events between groups (22.8% vs. 25%).
Study Author Conclusions	Gastrografin administered through a nasointestinal tube was more effective than enema in treating faecal impaction, improving stool consistency, constipation severity, and quality of life. It should be considered as a first-line therapy.
Critique	Strengths include the randomized controlled design and clear outcome measures. Limitations involve the lack of long-term follow-up and maintenance therapy, potential cost implications, and subjective assessment of constipation severity and symptoms.

References:
[1] [1] Gu L, Ding C, Tian H, et al. Use of gastrografin in the management of faecal impaction in patients with severe chronic constipation: a randomized clinical trial. ANZ J Surg. 2019;89(3):239-243. doi:10.1111/ans.14863

Clinical and growth outcomes after meconium-related ileus improved with Gastrografin enema in very low birth weight infants
Design	Observational, retrospective, single-center chart review N= 72
Objective	To identify the incidence of and factors associated with meconium-related ileus (MRI) and secondarily sought to investigate clinical and growth outcomes after water-soluble contrast media (Gastrografin) enema
Study Groups	Gastrografin enema (n= 24) Control (n= 48)
Inclusion Criteria	Very low birth weight infants with MRI
Exclusion Criteria	Chromosomal anomalies, other congenital disorders, pre-existing gastrointestinal abnormalities
Methods	Data were analyzed from very low birth weight infants born in Korea in the neonatal intensive care unit. Demographic characteristics, perinatal risk factors, patient clinical data, treatments, and outcomes were collected, with infants receiving Gastrografin enema matched (1:2) against a control cohort. At the institution, Gastrografin enema was provided after unresolved MRI following several attempts of routine procedures (e.g., rectal stimulation, glycerin enema, and warm saline enema). Gastrografin was diluted with normal saline at a ratio of 1:3 for a total of 20 mL (5 mL of Gastrografin and 15 mL of normal saline). The solution was then manually injected with <1 mL/sec velocity, with the amount injected ranging between 15-20 mL based on abdomen distension or resistance. Gastrografin enema was repeated if meconium was not excreted within 24 h after enema, or if abdominal distension increased, on a once-daily basis. Follow-up abdominal plain radiography was done after 6-12 h.
Duration	February 1, 2009 to March 1, 2019
Outcome Measures	Clinical outcomes
Baseline Characteristics		Gastrografin enema (n= 24)
	Gestational age, weeks	28.6 ± 2.8
	Birth weight, g	1,054.1 ± 235.4
	Gastrografin enema frequency	2.8
	Compared to the control group, gestational age and birth weight were not statistically different.
Results	Endpoint	Gastrografin enema (n= 24)	Control (n= 48)	Odds ratio (95% CI)	p-value
	Severe IVH, stage ≥3	4.2%	4.2%	1.00 (0.086-11.613)	1.000
	ROP stage ≥ 2	20.8%	27.1%	0.709 (0.219-2.289)	0.564
	ROP laser	20.8%	25.0%	0.789 (0.242-2.575)	0.695
	Moderate to severe BPD	54.2%	29.2%	2.87 (1.039-7.927)	0.039
	Mechanical ventilation Duration, days	87.5% 27.0 ± 37.2	87.5% 13.2 ± 20.8	1.000 (0.227-4.400) -	1.000 0.046
	Hospitalization period, days	97.9 ± 51.2	85.7 ± 29.8	-	0.211
	Late onset sepsis	12.5%	6.3%	2.143 (0.399-11.521)	0.393
	Mortality	8.3%	2.1%	4.273 (0.368-49.676)	0.256
	Abbreviations: CI, confidence interval; IVH, intraventricular hemorrhage; ROP, retinopathy of prematurity; BPD, bronchopulmonary dysplasia MRI resolved at a mean of 5.2 days after Gastrografin enema. There was no difference in the number of days taken to achieve full enteral feed or the duration of parenteral nutrition between cases and controls. The Z-scores of weight and height at birth, and corrected age at 37 weeks and 6 months were not statistically different.
Adverse Events	No complications, such as perforation or dehydration, related to the procedure during or after administering Gastrografin enema. Two patients died after Gastrografin enema administration, but these deaths were not associated with the study drug.
Study Author Conclusions	Gastrografin enema in very low birth weight infants with meconium-related ileus was an effective and safe medical management. Following Gastrografin enema, very low birth weight infants with meconium-related ileus achieved similar subsequent feeding progress and similar growth levels as the control groups without meconium-related ileus.
InpharmD Researcher Critique	Limitations inherent to the use of retrospective, observational data apply to this study, in addition to use of a small sample size from a single center.

References:
[1] [1] Song WS, Yoon HS, Kim SY. Clinical and growth outcomes after meconium-related ileus improved with Gastrografin enema in very low birth weight infants. PLoS One. 2022;17(8):e0272915. Published 2022 Aug 11. doi:10.1371/journal.pone.0272915

Management of meconium-related ileus in very low-birthweight infants
Design	Retrospective, observational, single-center chart review N= 10
Objective	To determine the most appropriate management of extremely premature infants who presented with meconium-related ileus
Study Groups	Study cohort (N= 10)
Inclusion Criteria	Premature infants; treated for meconium-related ileus
Exclusion Criteria	Cystic fibrosis
Methods	Data of management and clinical course were analyzed from patients in Japan; all patients were treated by administration of water-soluble contrast enemas, with gentle infusion of 25-50% diluted water-soluble contrast medium (Gastrografin) in the rectum. Administration was interrupted once contrast medium flowed out of the anus.
Duration	January 1998 to December 2004
Outcome Measures	Clinical outcomes
Baseline Characteristics		Study cohort (N= 10)
	Gestational age, weeks Age at enema initiation, days	27 6.8
	Female	40%
	Birth weight, g	787
	Born by cesarean section	80%
	Pregnancy complications	70%
	Total enemas	30
	Pregnancy complications included gestational toxicosis requiring treatment (n= 2), oligoamnion (n= 2), placenta previa (n= 1), amnionitis (n= 1), and intrauterine growth retardation (n= 1). All of 10 infants required tracheal intubation and mechanical ventilation immediately after birth. All of 10 infants had passed some meconium and feeding had started in eight of them before the initiation of treatment.
Results	Endpoint	Study cohort (N= 10)
	Bowel obstruction improvement after contrast enema	80%
	For unsuccessful patients, one required surgical treatment post-enema and one died due to respiratory failure from respiratory distress syndrome and abdominal distension. In both unsuccessful patients, the contrast medium reached only the left colon and failed to pass thorough the ileocecal valve. The period until use of the enema was longer in these two patients than in the others, which may have contributed to treatment failure.
Adverse Events	See Results
Study Author Conclusions	Although administration of water-soluble contrast enemas can be effective for meconium-related ileus, reflux into the terminal ileum is essential for bowel obstruction to improve, so it is desirable to perform the procedure under fluoroscopic guidance.
InpharmD Researcher Critique	Specific doses of Gastrografin enemas were not provided in the text. The small sample size from a single center in Japan, in addition to use of retrospective data, limits applicability to a domestic patient population. Management of meconium-related ileus prior to use of Gastrografin enemas may be dated and differ from current day clinical practice.

References:
[1] [1] Shinohara T, Tsuda M, Koyama N. Management of meconiumrelated ileus in very lowbirthweight infants. Pediatrics International. 2007;49(5):641-644.

Routine Use of Gastrograffin Enema prior to the Reversal of a Loop Ileostomy
Design	Retrospective, observational chart review N= 81
Objective	To determine the routine use of gastrograffin enema prior to ileostomy reversal on patients’ management
Study Groups	Study cohort (N= 81)
Inclusion Criteria	Patients with low rectal cancer who underwent a low anterior resection with a covering loop ileostomy
Exclusion Criteria	Not disclosed
Methods	Data were obtained from patients who received gastrograffin enema prior to ileostomy reversal. A routine double-contrast gastrograffin enema is performed to check anastomosis, conducted under fluoroscopic guidance. A sufficient amount of gastrograffin contrast, enough to distend and highlight the anastomosis and the proximal bowel, was used.
Duration	3 years
Outcome Measures	Clinical outcomes
Baseline Characteristics		Study cohort (N= 81)
	Age, years	48-90
	Female	35.8%
	Time from operation to enema, weeks	22
Results	Endpoint	Study cohort (N= 81)
	30-day mortality rate	4.9%
	Stoma not closed	13.6%
	Three of 81 patients developed clinical signs of anastomotic failure for a clinical leak rate of 3.7%. These were confirmed radiologically, 1 patient was treated by radiological drainage but 2 patients required laparotomy and 1 died. Four patients died in the postoperative period as a result of pulmonary embolism, multi-organ failure secondary to acute liver failure, intra-abdominal sepsis secondary to anastomotic failure and postoperative pneumonia. 69 (85.2%) patients had a gastrograffin enema prior to loop ileostomy reversal to asses the integrity of the anastomosis, 4 (5.8%) of whom showed minor anastomotic leak on their gastrograffin enema but none of them had clinical signs or symptoms suggestive of clinical anastomotic failure.
Adverse Events	See Results
Study Author Conclusions	The fact that the incidence of positive anastomotic leak on gastrograffin enema in patients with an uncomplicated post-operative course is low should make us consider abandoning the routine use of gastrograffin enema before stoma closure, and a gastrograffin enema should be only used selectively to confirm a clinical suspicion of anastomotic leak.
InpharmD Researcher Critique	Doses of gastrograffin enema utilized were not provided. Use of a small sample size with a limited period of follow up introduces possibility of not capturing more rare adverse events.

References:
[1] [1] Khair G, Alhamarneh O, Avery J, et al. Routine use of gastrograffin enema prior to the reversal of a loop ileostomy. Dig Surg. 2007;24(5):338-341. doi:10.1159/000107713

Gastrografin Enema to the Rescue of the Glorious Cecal Bascule
Design	Case report
Case presentation	A 74-year-old woman admitted for community-acquired pneumonia developed progressive lower abdominal discomfort and severe constipation with no bowel movement for 8 days despite multiple laxatives, enemas, and manual disimpaction. Her history included gastroesophageal reflux disease, hiatal hernia, Barrett’s esophagus, chronic obstructive pulmonary disease, and chronic constipation, without prior abdominal surgery. Examination showed abdominal distension and hypoactive bowel sounds without tenderness, and laboratory studies were unremarkable. Abdominal imaging demonstrated marked colonic distension with cecal dilation up to 12.8 cm on x-ray. CT imaging showed the cecum displaced to the left lower quadrant with a diameter of 10 cm, compared with prior right lower quadrant positioning, raising concern for cecal bascule. A Gastrografin enema resulted in rapid decompression with prompt bowel movement and symptom relief. Follow-up imaging confirmed resolution of colonic dilation, and the patient completed pneumonia treatment and was discharged in stable condition without documented recurrence or readmission.
Study Author Conclusions	Cecal bascule should be considered in elderly patients with colonic distension unresponsive to standard management for pseudo-obstruction. While surgery remains the gold standard for cecal volvulus, nonoperative treatment with Gastrografin enema may be effective in select patients without signs of ischemia or perforation. Early radiologic evaluation, careful patient selection, and close follow-up are essential in managing these rare and potentially serious presentations.

References:
[1] [1] Bangash B, Pean D, Khasria G, Hader I. Gastrografin Enema to the Rescue of the Glorious Cecal Bascule. ACG Case Rep J. 2025;12(7):e01752. Published 2025 Jul 14. doi:10.14309/crj.0000000000001752