Prospective,Randomized,Pilot Study Evaluating the Effect of Ice Chips Administration versus None on the Bitterness of Crushed Medications in Postoperative Bariatric Patients

Introduction

The provision of medication postoperatively for bariatric patients is challenging for both the nurse and the patient. Bariatric surgeries may be of the restrictive type (e.g., laparoscopic adjustable gastric banding (LAGB), sleeve gastrectomy, or vertical banded gastroplasty) or a combination of restrictive and malabsorption type (e.g., open or laparoscopic gastric bypass). Regardless, postoperatively the administration of all oral medication must be provided to bariatric patients in a crushed or liquid form. This is done for up to 8 weeks postoperatively because of swollen tissue around the stomach during gastric banding or to prevent suture line damage or blockage at the gastric-jejunal anastomosis. The bitterness of the crushed medications is a challenge for post-surgical bariatric patients. Direct care bariatric nurses who care for these patients routinely experience negative reactions by patients who require oral administration of their crushed medications.

The original “taste map” concept proposed by D.P. Haning in 1901, which described the four distinct areas of the tongue for sweet, bitter, salt, and sour tastes, has been disproved by recent evidence that shows that there are distinct cell types with specific receptors on the tongue responsible for detecting the five basic tastes: bitter, sweet, sour, salty, and umami. ¹ Transient receptor potential (TRP) channels are responsible for these taste perceptions, as well as other sensory modalities, including smell, temperature, and mechanical forces.^2,3 This family of receptor channels is suggested to play a role in these somatosensory modalities, forming a chemosensory flavor network that regulates perceptions of aversive or pleasurable foods.^4–6 Increases and decreases in temperature have been shown to enhance or diminish the perception of taste.^7,8 This study proposes to determine if a reduction in temperature will impact the perception of bitter or unpleasant taste associated with the administration of crushed medication to postoperative bariatric patients who are limited in the volume and content of ingested substances. Crushing medication is commonplace among nurses in the administration of medication to patients who have difficulty swallowing, and there has been little evidence reported to suggest any harm to patients.^9,10 However, the bitterness or unpleasantness of crushed medicine to postoperative patients is problematic and a solution is needed.

Nurse researchers theorized that a nursing intervention of having the patient place ice chips in their mouth prior to and immediately after crushed medication administration may desensitize the patient's taste buds through the numbing effect of the ice chips. It was further theorized that this desensitization may decrease the bitterness and unpleasant taste perception by the patient of the crushed medication. If a simple nursing intervention of an ice chips provision procedure with medication administration would be effective, direct care bariatric nurses who care for these patients routinely could implement this procedure to decrease negative reaction by patients who require oral administration of their crushed medications. A literature review was conducted to determine if any ice chips nursing intervention research related to medication administration had been conducted. The following search produced no relevant results: years 2000–2010, in Medline (taste buds, taste threshold, taste, taste perception, temperature) and (crush, pill, medication, or ice); and CINAHL (taste or taste disorders or bitter) and (temperature or cold or ice). Relevant literature was found in basic nursing texts that mentioned the use of ice chips to dull patients' taste buds before taking unpleasant medications, but no research studies supporting the practice were cited. ¹¹

As a first step to conducting evidence-based research on the ice chips nursing intervention, researchers developed rating scales and tested pretest/posttest validity of two dimensions of subject medication perception: taste and bitterness. Twelve healthcare professionals ranked perceptions on two 5-point categorical scales, following consumption of 120 mg of crushed Bitter Orange capsule mixed with 10 mL of room temperature water: Crushed Medication Scale, where 1 = “least unpleasant,” 2 = “less unpleasant,” 3 = “neutral,” 4 = “more unpleasant,” and 5 = “most unpleasant”, in response to “How do you rate the taste of your medication?”; and Crushed Medication Bitterness Scale, where 1 = “least bitter,” 2 = “less bitter,” 3 = “neutral,” 4 = “more bitter,” and 5 = “most bitter”, in response to “How do you rate the bitterness of your medication?” Perceptions were ranked at two time points: baseline and 1 h post-baseline. There were statistically significant differences (p < 0.05) in pair-wise perceptions of taste, but no statistical difference in the pair-wise perception of bitterness, at baseline and 1 h from baseline. The bitterness scale was assessed and showed good internal consistency and reliability (Kappa < 0.6). The taste scale was less strong (Kappa < 0.5). Therefore, for purposes of this study, both scales were used. However, the study's primary measure focused on the Crushed Medication Bitterness Scale.

The purpose of this study was to test whether a nursing intervention of administering ice chips to postoperative bariatric patients' tongues before and after administering crushed medications would result in improved patient perception of taste and/or bitterness.

The hypothesis of this study was that the ice chips procedure provided to postoperative bariatric patients with their crushed medication administration would result in an improved bitterness rating compared with patients who received standard nursing care, which did not require ice chips as part of the crushed medication administration procedure.

Materials and Methods

This prospective, randomized, pilot study included 100 adult patients admitted to the hospital surgical unit. This study underwent Institutional Review Board (IRB) review. All subjects provided signed informed consent.

Study inclusion criteria were: (1) ≥18 years of age, (2) admission postoperatively for laparoscopic gastric band (LAGB) or gastric bypass, (3) requirement for crushed medications postoperatively, and (4) ability to communicate in the English language. Exclusion criteria were: (1) patients experiencing postoperative complications that interfered with perception of taste or bitterness (e.g., vomiting, anastomotic leaks, rhabdomyolysis, pneumonia/infiltrates), (2) Intensive Care Unit admission, and (3) patients not capable or willing to complete study scales. For subjects who met the eligibility criteria, study procedures were conducted on the first postoperative day. Subjects were randomized in a 1:1 ratio in blocks of four to one of the two following groups: Group 1 (n = 50) ice chips group; Group 2 (n = 50) no ice chips group. Randomization was stratified by restrictive (restrictive surgery type including LAGB) and combination (combination of restrictive and malabsorption bariatric surgery, which included open or laparoscopic gastric bypass). Subjects who withdrew from the study were replaced to achieve a total of 100 patients who completed the study procedures.

Subjects randomized to Group 1 received the ice chips nursing intervention as follows. All medication scheduled and pro re nata (PRN) medications were used at one time period; medications were cut in half, divided into two medication cups, crushed with a mortar, and 10 mL of room temperature water was added to the crushed medications in each medication cup.

The pre-ice medication administration procedure was to ask the subject to avoid smelling the medication, to swallow the contents of one of the medication cups, and then to complete immediately the two study scales (see Fig. 1). If needed, additional room-temperature water (5–10 mL) was used to ensure the complete medication dose was delivered.

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FIG. 1.

Crushed Medication Bitterness Scale.

The post-ice medication administration procedure was to wait 5 min before diluting the second medication cup with 10 mL of room-temperature water. Subjects were asked to avoid smelling the medication, to place 15 mL of ice chips on their tongue, and leave them in their mouth for up to 1 min. Any remaining ice was spit back in the cup. The subject then swallowed the contents of the medication cup. If needed, additional room-temperature water (5–10 mL) was used to ensure the complete medication dose was delivered.

Immediately thereafter, subjects placed 15 mL of ice chips on their tongue and left them in their mouth for 1 min. Subjects then immediately completed the two study scales (see Fig. 1). The scale survey was intended for all medications that were crushed together for that dosing time period.

Subjects randomized to Group 2 followed standard nursing procedure for medication administration. Specifically, scheduled and PRN medications were used. The medications were placed in one medication cup, crushed, and 10 mL of room-temperature water was added. Subjects were asked to avoid smelling the medication and to swallow the contents of the medication cup, then immediately complete the two study scales (see Fig. 1). If needed, 5–10 mL of room-temperature water was used to ensure the complete medication dose was delivered.

Per standard of care, sustained-released medications were not used in this research study as they cannot be crushed.

Data recorded by study investigators on study Case Report Forms were as follows: demographics, surgical information, comorbidities, height and weight for Body Mass Index (BMI), subject experience with previous administration of crushed medications, medications administered, time since last oral intake and type of oral intake, and admission and discharge dates.

The sample size of 100 subjects was based on 80% power that the study would detect relationships between the independent and dependent variables with 95% confidence, assuming that the true difference in bitterness perception is at least 1.2 units on the bitterness scale. These relationships were based on scaled perceptions of “bitterness” provided by study subjects on the following scale: Crushed Medication Bitterness Scale, where 1 = “least bitter,” 2 = “less bitter,” 3 = “neutral,” 4 = “more bitter,” 5 = “most bitter,” in response to “How do you rate the bitterness of your medication”?

The data-analysis software used was SAS for Windows (V9.2; SAS Institute, Inc., Cary, NC).

Results

A total of 101 subjects were enrolled in this study to obtain 100 patients, 50 per group, who completed the study. The one study withdrawal was for a subject who did not continue to meet the eligibility criteria. The distribution of demographics and characteristics according to study group is shown in Table 1. The majority of study subjects were Caucasian (69%), females (81%), and aged 35–54 years (58%). In the intervention group, 26% had restrictive surgery, which was similar to the 28% in the control group. A significant finding was the breakout of combination-surgery type by study-group type. Of these bariatric study subjects, the majority had hypertension and more than 25% had sleep apnea, dyslipidemia, diabetes, and at least one other comorbidity. The mean BMI was significantly greater in the control group. There were no significant differences in LOS between the groups.

In the intervention group, as a result of the ice chips intervention, there was a 1.16-point mean improvement, or reduction, in bitterness (3.66 to 2.62; t = 5.32, p < 0.0001) and a 1.04 improvement in taste (3.86 to 2.70; t = 4.72, p < 0.0001). Mean rankings for both taste and bitterness among the control group, both 3.9, were significantly different (p < 0.01) from the mean taste (2.7) and bitterness (2.62) rankings reported by the intervention group after the ice chips intervention. Table 2 shows bitterness and taste mean ratings according to study group and stratification by surgical type (restrictive and combination surgery). Notably, both bitterness and taste mean ratings reported by the intervention group after the ice chips intervention are significantly different (p < 0.01) from those reported by the intervention group before the ice chips intervention and those reported by the control group who had no ice chips.

An ordinary least squares regression model was fitted to test the association between study-group type and bitterness and taste scale. The intervention group resulted in a full point improvement in the bitterness scale (p < 0.0001) when controlling for age, race, gender, type of surgery, baseline BMI, type of surgical procedure, and preoperative comorbidities (see Table 3). By contrast, the ice chips intervention, controlling for age, race, gender, type of surgery, baseline BMI, type of surgical procedure, and preoperative comorbidities, resulted in increased “unpleasantness” (p < 0.05) in taste reported by patients when asked to rank the taste of medications administered post ice chips intervention (see Table 4); the ice chips intervention was associated with a one-fifth-point increase in unpleasantness when measured on a 5-point scale.

Table 5 shows the mean ranking for bitterness and taste on the 5-point scale (1 being the most pleasant and 5 being the most unpleasant) for patients in both study groups. A significantly better ranking (p < 0.05) among ice chips patients was observed in both bitterness and taste for analgesics and antihypertensives when administered with other medications (overall) and as the only medication (single dose). There was also a significantly better ranking observed among ice chips patients for antidepressant medications when administered with other medications. There were no cases of single-dose administration for medications in the category of thyroid hormone replacements and antidepressants. Table 6 provides medication use factors by study group. While none of the findings were considered to be clinically relevant with respect to patient perception of bitterness and taste, there were two statistically significant findings. The analysis of type of last oral intake completed demonstrated a statistically significant difference between the groups, with a greater percentage having had food in the intervention group. Also there was a greater percentage of diuretics administered in the intervention group.

Discussion

From an evidence-based practice perspective, the results of this research support use in the postoperative bariatric population of the simple nursing intervention of an ice chips provision procedure prior with medication administration to reduce bitterness and improve taste perception of crushed medications. As shown in Table 5, use of the ice chips intervention demonstrated statistical significance for certain types of medications in categories grouped for purposes of this research as analgesics (oxycodone/acetaminophen, hydromorphone, and meperidine), antihypertensives (propranolol, lisinopril, verapamil, diltiazem, lotensin, varsartan, methyldopa, olmesartan, clonidine, metoprolol, atenolol, hydrochlorothiazide, and carvedilol), and antidepressants (bupropion, escitalopram, paroxetine, and venlafaxine). A limitation of this research was that taste and bitterness was not rated by subjects individually for every medication dosing, as patients may have required more than one medication at a dosing time period. As administration of crushed medication requires fluid, administering each medication separately may require more fluid than allowed postoperatively for bariatric surgery patients. Further research is warranted by medication categories on patient perception of taste and bitterness using the ice chips intervention.

Further research is recommended using ice chips intervention provided only after crushed medication administration.

The lack of taste improvement per the multivariate regression analysis is considered to be an anomalous finding due to the controls for the independent variables simultaneously.

Conclusions

The hypothesis of this study was met, as the ice chips intervention provided to postoperative bariatric patients pre- and post-crushed-medication administration significantly improved their taste and bitterness perception ratings. Nurses can easily implement the ice chips intervention to improve bariatric patient experiences associated with crushed medication administration.