New Thinking on Gastrointestinal Decontamination
New Thinking on Gastrointestinal Decontamination
Authors: Christina E. Hantsch, MD, Fellow, Donna L. Seger, MD, Assistant Clinical Professor, and Tim Meredith, MD, Professor of Medicine and Pathology, Center for Clinical Toxicology, Vanderbilt University Medical Center, Nashville, TN.
Peer Reviewers: Milton Tenenbein, MD, Professor of Pediatrics, Medicine, and Pharmacology, University of Manitoba, Winnipeg, Manitoba; Lester Haddad, MD, FACEP, Attending Emergency Physician, Emergency Medicine Residency Program, Medical College of Georgia, Augusta, GA.
Optimal care of the poisoned or potentially poisoned pediatric patient requires an understanding of the controversies surrounding gastrointestinal decontamination. These controversies have been heightened by the recent publication of joint position statements by the American Academy of Clinical Toxicology and the European Association of Poisons Centres and Clinical Toxicologists.1
The challenge with poisoned patients is to determine which patients are at risk for developing toxicity and, therefore, those who require treatment interventions. In children at low risk for toxicity, the use of decontamination procedures and therapeutic interventions can actually be more hazardous than the exposure itself. In 1996, for example, two children died, reportedly due to complications that followed administration of activated charcoal. One was asymptomatic at presentation following a nontoxic exposure, and the other had only mild drowsiness possibly due to the suspected ingestant.2
Recommendations and practice regarding gastrointestinal decontamination have changed significantly during the last few years. Gastric emptying procedures are employed far less frequently than in the past. In 1983, syrup of ipecac was given to 13.4% of poisoned patients but in 1996 to only 1.8% of cases.2 Over the same time period, the use of activated charcoal increased from 4.0% to 7.3% of cases.2 Appropriate management of poisoned patients no longer requires gastrointestinal decontamination as a matter of routine. Each exposure requires careful and individual evaluation, while methods of gastrointestinal decontamination and their indications continue to be reviewed and debated. Gastrointestinal decontamination remains one of the most controversial issues in clinical toxicology today.
The Editor
The paucity of solid scientific evidence regarding the utility of gastrointestinal decontamination (GID) makes firm treatment recommendations difficult, particularly in today’s environment of "evidence-based health care." The applicability of results derived from volunteer studies using nontoxic doses of substances to the overdose situation is limited. Conclusions reached in such studies cannot be extrapolated with certainty to patients with toxic ingestions, not least because the pharmacokinetic principles that apply to therapeutic dosing rarely apply to the overdose setting. Yet clinical trials in overdose patients are fraught with problems. They are difficult to control and are often flawed by selection bias. However, three large outcome studies3-5 have shown, for the majority of overdose patients, that GID does not favorably affect outcome and may be accompanied by complications.
Kulig et al3 randomized 116 overdose patients presenting with abnormal mental status to undergo or not undergo gastric lavage prior to administration of activated charcoal. They found no significant difference between the two groups in hospital admission rates or incidence of clinical deterioration or improvement during the first six hours. For patients presenting within one hour of ingestion, the rate of clinical improvement during the first six hours was significantly greater (29% vs 9%) for the gastric lavage group. However, seven patients were removed from the control group and underwent lavage, potentially accounting for the greater clinical improvement found in the lavage group. Merigian et al4 randomized 357 symptomatic overdose patients to undergo gastric emptying (ipecac or gastric lavage depending on mental status) prior to administration of activated charcoal. They found no difference between the two groups in length of stay in the ED, length of stay in ICU, length of time intubated, or incidence of clinical deterioration over the first six hours. Of note in this study, gastric emptying was associated with an increased incidence of endotracheal intubation (55% vs 14%) and aspiration pneumonia (8.5% vs 0%). In the most recent study, Pond et al5 randomized 342 obtunded overdose patients to either undergo or not undergo gastric lavage prior to administration of activated charcoal. They found no significant difference in the incidence of clinical deterioration or improvement during the first six hours irrespective of whether the presentation was within one hour of ingestion. However, only 55 patients presented within one hour of which just 14 were not lavaged. Unfortunately, none of these studies were limited to children; thus, limiting the applicability of these results to the pediatric setting.
Aside from these three outcome studies, there are others that have looked at additional aspects of the "effectiveness" of different methods of GID, namely syrup of ipecac, gastric aspiration and lavage, single-dose activated charcoal, cathartics, and whole bowel irrigation. (See Table 2.)
Syrup of ipecac is a nonprescription medication that is a mixture primarily of two plant-derived alkaloids, emetine and cephaeline. The goal of ipecac administration is gastric emptying by induction of emesis. Ipecac induces vomiting by a central stimulant effect on the chemoreceptor trigger zone (CTZ) and by a direct irritant effect on the gastric mucosa.6
Clinical Use and Indications. Although four animal studies, 10 human volunteer studies, and three studies in poisoned patients using markers have shown that administration of ipecac within 30 minutes of ingestion of a substance results in recovery of up to 50% of the ingested material, the amount recovered falls off rapidly as further time elapses (< 30% by 60 minutes). More importantly, there is no evidence that use of ipecac improves clinical outcome in any type of poisoning.3,4,7-11 The three clinical studies3-5 described in the preceding section revealed no change in outcome following the administration of ipecac. Outcome measures examined include hospital admission rates, complication rates, mortality rates, length of stay in the ED and intensive care unit, and, in the context of pediatric acetaminophen poisoning,10,11 the need for N-acetylcysteine administration. In addition, ipecac administration prolonged length of stay in the ED7,8 and delayed administration of antidotal therapy or activated charcoal by more than two hours.8
The use of syrup of ipecac has diminished substantially in recent years and cannot be recommended as a routine measure. Prehospital administration should only occur under the direction of a physician or poison control center. It is likely to be of most value when a toxic amount of a highly toxic substance has been ingested within the preceding 60 minutes in an isolated geographic location with limited access to medical care, though this has yet to be demonstrated in a formal study. Because the effectiveness of ipecac-induced emesis in achieving gastric emptying is extremely variable between individuals, there is no role for the use of ipecac without subsequent medical evaluation as soon as possible. In the view of most, syrup of ipecac no longer has a role in the hospital setting.
Adverse Effects, Complications, and Contraindications. Ipecac administration leads to protracted vomiting (> 1 hour) in 13-17% of patients,12-13 sedation in 10-21%, and diarrhea in 5-26%.12-14 Bradycardia from vagal stimulation can occur.15 Reports of other complications are rare but include Mallory-Weiss esophageal tears.16,17 pneumomediastinum,18 intracranial hemorrhage,19 traumatic diaphragmatic hernia,20 and gastric rupture,21 and asystole (following beta blocker overdose).
Ipecac is contraindicated in patients with, or the potential to develop, central nervous system depression, seizures, any other condition that would impair airway protection, or hemodynamic instability. Ingestion of hydrocarbons or corrosives, anticipated use of oral antidotes or whole bowel irrigation, or a medical condition potentially worsened by induction of emesis represent additional contraindications.
Gastric aspiration and lavage is a procedure employed to achieve gastrointestinal decontamination by physically emptying the stomach. It consists of passage of an orogastric tube, aspiration of gastric contents, and sequential instillation and aspiration of fluid until the effluent is clear. The tube must be large enough in diameter (36-40 French) for particulate matter to pass through it. A nasogastric tube is not adequate. The procedure should not be attempted in small children in whom use of at least a 24 French tube is not possible. In theory at least, the volume of fluid instilled and aspirated should be small in order to minimize the chance of forcing gastric contents into the duodenum rather than recovering them. A toxic ingestion is not ruled out by the absence of pill fragments in the recovered fluid.
Clinical Use and Indications. The role of gastric lavage remains highly controversial. As with ipecac, animal studies have shown that the recovery of ingested substances following gastric lavage diminishes with increased time from ingestion (less than 30% by 20-30 minutes and less than 13% by 60 minutes).22,23 There are five reported volunteer studies of the use of gastric lavage.23-27 Three were performed less than 20 minutes after dosing, and two were undertaken at 60 minutes. Of these two, one showed a mean area-under-the-curve (AUC) reduction of 32% (NS) and the other achieved a mean reduction in salicylate excretion of 8% (P < 0.025). Eleven clinical studies have been reported, four of which compared unselected cases. The results of three of these studies3-5 have been reviewed above. In the the study by Saetta and Quinton,23 only 10 of 73 cases had more than 10 therapeutic doses of the ingested drug recovered in the lavage fluid. In the study by Kulig et al,3 patients presenting within an hour of ingestion who underwent gastric lavage improved more in six hours than those patients not undergoing lavage, but the numbers were small (16 vs 3), and there may have been selection bias. Subsequent studies4,5 have not demonstrated benefit in any group of patients.
Gastric lavage should not be employed as a routine measure in poisoned patients. However, until more evidence regarding patient outcomes becomes available, its use should be considered within one hour of ingestion of a life-threatening amount of a toxic substance. Toxic overdoses that may benefit from gastric aspiration and lavage include tricyclic antidepressant, calcium channel antagonist, or a "cellular" toxin such as colchicine or toxins that are not bound by charcoal (e.g, iron). Every such patient should be evaluated and managed individually. Advice from a poison center or toxicologist should be obtained if there is any uncertainty about appropriate management.
Adverse Effects, Complications, and Contraindications. Pulmonary aspiration of gastric contents is the most serious potential complication of gastric lavage.4,28-30 Because of this concern, gastric lavage is contraindicated in patients with an unprotected airway. Moreover, even with a cuffed endotracheal tube in place, aspiration pneumonia may follow gastric lavage.4 The use of gastric lavage should therefore also be avoided following ingestion of hydrocarbons or corrosives because of the risk of pulmonary aspiration. Other potential adverse effects include laryngospasm,31 hypoxemia,32 and cardiovascular abnormalities (ventricular ectopy, transient ST segment elevation).32 In rare instances, injury to the gastrointestinal tract4,33-35 or airway36 may occur.
Single-Dose Activated Charcoal
The aim of ipecac administration and lavage is prevention of toxicity by gastric emptying. The aim of single-dose activated charcoal therapy is to avert toxicity by adsorbing the ingested substances within the gastrointestinal tract and, thereby, preventing systemic absorption. (This contrasts with multiple-dose activated charcoal therapy, which is a means of enhancing elimination and is not considered in this article.)
Charcoal is the residue produced by the destruction of organic materials. Activation of charcoal refers to a process involving oxidizing treatments with activating agents that increase its adsorptive capacity by pore structure alteration, particle size reduction, and removal of previously adsorbed material.37 Adsorptive capacity is proportional to surface area, which in turn is inversely proportional to particle size. Currently available commercial preparations38 have surface areas of 950-2000 m2/g. Factors such as lipid solubility, ionization state, and pH influence the adsorption of a toxin to charcoal. Toxins that are lipophilic and nonpolar are adsorbed to a greater extent. Not all substances are significantly absorbed by charcoal, including, for example, inorganic acids, caustic alkalis, alcohols, and heavy metals (e.g., iron, lithium, and lead). For those substances that are adsorbed by activated charcoal, direct contact is required for the process to occur, and equilibrium is reached after 30 minutes of contact.39,40
Dose and Administration. The optimal amount of activated charcoal to be given as a single dose is not known. Traditionally, the recommendation has been for an amount at least 10 times that of the drug ingested,6 but this dose is based on in vitro observations and, in any case, in most poisonings, the amount ingested is not known reliably. Currently, the recommended dose of charcoal is 1g/kg in children up to one year of age, 25-50 g in children 1-12 years old, and 25-100 g in adolescents and adults. In practice, it should be the maximum amount tolerated. (See Table 4.)
Clinical Use and Indications. At least 59 animal studies have been reported that evaluate the "effectiveness" of activated charcoal in adsorbing toxins. These studies confirm charcoal adsorption of approximately 70 different substances by documenting decreased systemic absorption/effect. More than 100 volunteer studies have demonstrated that the bioavailability of ingested substances is decreased 40-62% if activated charcoal is administered within 30 minutes of the ingestion and 24-78% if administered within 60 minutes.1 In these studies, however, the doses used were nontoxic and individual studies employed a different charcoal dose, charcoal to toxin ratio, and time to charcoal administration. The effectiveness of activated charcoal has been assessed in only five clinical studies.4,41-44 Three compared charcoal to GID without charcoal.41-43 Comstock et al41 demonstrated a decline in drug concentration in moderately poisoned patients who were given charcoal in comparison to those who were not, but the validity of the results is uncertain due to perceived flaws in study design and analytical errors. Hulten et al42 compared charcoal alone to charcoal after gastric lavage. They did not find significant differences in areas-under-the-curve, maximum drug concentrations, incidence of admission or duration of stay in the intensive care unit, incidence or duration of intubation, or duration of hospital stay. Unfortunately, the use of gastric lavage may have delayed administration of charcoal and the dose of charcoal used for this study was low (20 g for an adult). Crome et al43 did not find improved clinical outcome following charcoal administration to antidepressant overdose patients. The remaining two studies,4,44 compared charcoal to a control group with no GID. Neither found improvement in outcome as a result of activated charcoal administration.
Despite little clinical evidence to support single-dose activated charcoal as an effective means of gastrointestinal decontamination (and certainly no evidence of improved patient outcome), the use of activated charcoal has increased in recent years. That having been said, there may be some benefit resulting from administration of single-dose activated charcoal to patients who present less than one hour from the time of a potentially toxic ingestion, but it has yet to be demonstrated.
In response to the move away from use of syrup of ipecac, activated charcoal is being marketed for home administration. However, as with ipecac, prehospital use of charcoal should only be on the recommendation of a physician or poison control center.The use of charcoal should always be associated with a formal medical evaluation.
Adverse Effects, Complications, and Contraindications. There are few adverse effects or complications that result from use of single-dose activated charcoal.3,4,41,42 However, as exemplified by the two pediatric fatalities that occurred in 1996, when complications do occur, they can be significant.2 Activated charcoal is contraindicated in patients with inadequate airway protection because of the risk of pulmonary aspiration.36 Charcoal itself is inert and aspirated gastric contents are more likely than charcoal to be the cause of subsequent pulmonary problems, unless large amounts of charcoal have been inadvertently instilled directly into the trachea. Use of charcoal is contraindicated in patients who have ingested hydrocarbons or corrosives, because of concern regarding aspiration and GI tract perforation/interference with endoscopic visualization, respectively.
Emesis has been reported as being more frequent when sorbitol is added to activated charcoal. Charcoal alone is associated with a 15% incidence of emesis;44 charcoal with sorbitol is associated with a 16-56% incidence.8,45
The goal of cathartic administration is to decrease transit time of toxic substances in the gastrointestinal tract to decrease their absorption. Sorbitol, magnesium citrate, and magnesium sulfate have been used for this purpose.
Clinical Use and Indications. There are four reported animal studies of the effect of cathartics alone on the bioavailability of drugs, achieving AUC value of 40-109%.46-49 In human volunteers, there have been five studies50-54 of the effect of cathartics alone on drug bioavailability and seven51,53-58 of the effects of sorbitol plus activated charcoal. Cathartics alone did not substantially reduce drug absorption, and data are conflicting concerning the effect of the addition of sorbitol to activated charcoal on drug absorption. Aside from these studies, there are others involving volunteers in which the effect of cathartics plus activated charcoal on intestinal transit times has been investigated.59-61 Transit times are reduced, but AUC values are conflicting. There are no clinical studies of the effect of cathartics, with or without activated charcoal, on the bioavailability of drugs taken in overdose. Additionally, there are no clinical studies of the ffect of cathartics on patient outcome following drug overdose.
On the basis of available evidence, the use of cathartics alone cannot be recommended as a routine measure in the treatment of poisoned patients. There is no evidence that patient outcome is improved and, in addition, morbidity may result.
Adverse Effects, Complications, and Contraindications. The use of cathartics is commonly complicated by nausea, abdominal cramps,56,58 and vomiting.5,60 Transient hypotension,56 presyncope, dehydration, hypermagnesemia, and hypernatremia have also been reported after multiple or supratherapeutic doses.60,62 Cathartics are contraindicated in patients with an unprotected airway, and in those with ileus, intestinal obstruction, recent abdominal trauma or surgery, or severe diarrhea. Ingestion of a corrosive or the presence of volume depletion, hypotension, or significant electrolyte imbalance also represent contraindications.
Whole bowel irrigation (WBI) is a procedure used to decontaminate the entire gastrointestinal tract. The technique was originally designed to improve visualization at colonoscopy and barium enema examinations.63 The theory that it could also force passage of toxins through the gastrointestinal tract before their complete absorption took place led to its use in poisoned patients for whom other means of GID would be of no benefit.
WBI consists of administration of a polyethylene glycol electrolyte solution (PEG-ES) via a nasogastric tube. For children 9 months to 6 years of age, the recommended rate is 500 mL/h; for children 6 to 12 years old, 1000 mL/h; and for children older than 12 years and for adults, the recommended rate is 1500-2000 mL/h.64 (See Table 5.) The infusion is usually continued for several hours with the intended end point being a clear rectal effluent. A nasogastric tube is required because patients are not able to drink the PEG-ES solution as fast as is necessary to achieve continuous flow of solution through the intestinal tract. Continuous flow is believed to be particularly important for substances such as iron that otherwise embed into the gastrointestinal mucosal surface.
Clinical Use and Indications. Two animal studies of WBI have been reported, with one demonstrating benefit, at least in theory (mean total body clearance of paraquat was increased from 5.7 to 13.2 L/h).65,66 There are also seven volunteer studies.67-73 Three (using ampicillin,67 enteric-coated aspirin,68 and sustained-release lithium,69 respectively) showed a significant reduction in bioavailability (by 67-73%). One volunteer study of WBI using coffee beans failed to demonstrate enhanced gastrointestinal clearance.73
There are no reported controlled clinical studies of the utility of WBI. However, there are case reports74-79 involving patients with ingestions of iron, sustained-release pharmaceuticals, latex packets of cocaine, zinc sulfate, lead oxide, and arsenic in which WBI appeared to be effective and improve clinical outcome. However, most of the patients who ingested toxic doses of iron also received specific antidotal therapy.
WBI cannot be recommended as a routine treatment measure in poisoned patients. There is only anecdotal evidence that patient outcome is improved and it may cause morbidity. (See Table 5.) WBI is only recommended for potentially toxic ingestions of sustained-release or modified-release pharmaceuticals (e.g., calcium channel antagonists), iron, arsenic, lead or zinc, and packets of illicit drugs.
Adverse Effects, Complications, and Contraindications. WBI can cause nausea, vomiting, bloating, and abdominal cramps.63,68 Emesis may be related to the procedure or be a manifestation of toxicity of the ingested substance(s). The frequency of vomiting due to the procedure can be decreased by placing the patient in a semi-upright position and by slowing administration of the PEG-ES. However, pulmonary aspiration is a potential complication of whole bowel irrigation, and if anti-emetics are to be used, avoid those which are sedating. Do not use WBI in patients with impaired airway reflexes.
WBI is contraindicated in patients with bowel obstruction or perforation, ileus, gastrointestinal hemorrhage, hemodynamic instability, intractable vomiting, or other conditions that may be worsened by the procedure. Administration of PEG-ES does not cause fluid imbalance or electrolyte abnormalities.80
In the past, GID was assumed to prevent or reduce toxicity of ingested poisons. Recent clinical studies in overdose patients and, particularly, outcome assessment have demonstrated the importance of reevaluating the need for GID as well as the methods employed.
For the practicing clinician today, it is important to distinguish those patients exposed to a toxic substance who are at risk for developing significant toxicity from those who are not. Patients with potentially toxic ingestions may benefit from decontamination procedures but, even in this subset, there is no evidence of improved outcome. GID procedures should no longer be viewed as a required component of the clinical management of all overdose patients. Each patient should be evaluated individually, and whenever there is doubt about appropriate management, a poison control center or clinical toxicologist should be consulted.
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