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Influence of Histamine Receptor Antagonists on the Outcome of Perforated Appendicitis Analysis from a Prospective Trial

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Influence of Histamine Receptor Antagonists on the Outcome of Perforated Appendicitis Analysis from a Prospective Trial ORIGINAL ARTICLE Z Influence of Histamine Receptor Antagonists on the Outcome of Perforated Appendicitis Analysis From a Prospective Trial Shawn D. St. Peter, MD; Susan W. Sharp, PhD; Daniel J. Ostlie, MD Hypothesis: Diphenhydramine blocks the H1 receptor receiving the medication with those who did not using to treat pruritus or to induce sleep, while ranitidine blocks the t test for continuous variables and ␹2 test for dis- Յ the H2 receptor to suppress gastric acid. They are often crete variables. Significance was defined as P .05. given to ill patients, such as those with perforated ap- pendicitis. However, these receptors are integral to the Results: Significant correlations were found between the inflammatory response, and to our knowledge, the im- use of ranitidine (P=.05) or diphenhydramine (P=.03) pact of H1 or H2 blockade on outcome in the setting of and the development of an abscess. Direct comparison perforated appendicitis has never been evaluated. found no differences in patient or operative variables in those given either medication compared with those re- Design: Prospective randomized trial. ceiving no doses. Abscess rate in those receiving neither medication (n=41) was 10%. Those given only raniti- Setting: Referral center. dine (n=24) or diphenhydramine (n=17) had doubled abscess rates of 17% and 18%, respectively. Those given Patients: Children undergoing an operation for perfo- both medications (n=16) had a quadrupled abscess rate rated appendicitis from April 2005 to November 2006. of 44% (P=.03). Main Outcome Measures: We conducted multivar- Conclusions: Ranitidine or diphenhydramine given to iate analysis with Pearson correlation on data from a pro- patients with perforated appendicitis may increase the spective randomized trial comparing antibiotic regimen risk of postoperative abscess. Therefore, these medica- after appendectomy for perforated appendicitis and out- tions should not be used empirically in this population. come. Medications with a significant correlation to ab- scess development were investigated by comparing those Arch Surg. 2010;145(2):143-146 FTER APPENDECTOMY FOR tenuates itching caused by narcotic- perforated appendicitis, pa- induced histamine release. Ranitidine is also tients usually require a few a histamine antagonist, acting at the H2 re- days to regain bowel func- ceptor to reduce acid production in the tion. During this period, stomach by a noncholinergic pathway.1 Dur- Athey are normally allowed nothing by mouth ing the conduction of a prospective ran- or allowed insignificant intake like ice chips domized trial on perforated appendicitis, we and sips of water. Most patients receive ke- discovered that some patients were receiv- torolac tromethamine for pain, which can ing ranitidine and the abscess rate ap- lead to gastritis, and narcotics, which can peared higher in these patients regardless of the antibiotic regimen. Therefore, at the See Invited Critique end of this trial, we performed a thorough at end of article investigation of all medications given to these patients during the trial to elucidate cause itching. These patients may be given the effect nonantimicrobial medications a medication for gastric acid suppression or have on the outcome of patients with per- an antihistamine for itching or insomnia. In forated appendicitis. our hospital formulary, ranitidine is the medication available for gastric acid sup- METHODS pression and diphenhydramine is the anti- Author Affiliations: Center for histamine used for itching. Diphenhydra- PATIENTS Prospective Clinical Trials, mine exerts antihistamine effect by blocking Department of Surgery, The the H1 receptor on inflammatory cells, in- After obtaining institutional board approval, a Children’s Mercy Hospital, hibiting the release of cytokine-rich gran- prospective randomized trial was conducted on Kansas City, Missouri. ules from the cytoplasm.1 This effect at- children undergoing an operation for perfo- (REPRINTED) ARCH SURG/ VOL 145 (NO. 2), FEB 2010 WWW.ARCHSURG.COM 143 ©2010 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/27/2021 more days of intravenous antibiotics after which therapy was di- Table 1. Demographics and Outcomes for H1 Blockade rected by the results of further studies. The antibiotic therapy was randomized to either standard triple therapy with ampicillin, gen- Mean (SD) tamicin, and clindamycin or a 2-drug regimen of once-a-day dos- ing with ceftriaxone sodium and metronidazole. Blocked Not Blocked P The postoperative orders were computer entry from a stan- (n = 33) (n = 65) Value dardized order set that listed the medications that could be Age, y 8.6 (4.5) 8.6 (4.2) .97 chosen by simply checking the box next to each medication. Ra- Weight, kg 34.8 (23.1) 34.3 (20.9) .96 nitidine was an option on the order set that was ordered in a pro- Male, % 64 60 .79 vider-specific manner. The provider was not the surgeon in any Admission white blood 0.0184 (0.0060) 0.0170 (0.0051) .26 case but was influenced by 4 surgical nurse practitioners or the cell count, /µL rotating surgical residents. Diphenhydramine and ondansetron Days of symptoms at 3.4 (2.7) 2.9 (1.7) .26 hydrochloride were both on the order set as options to order on presentation an as-needed basis. Ketorolac could be ordered as a scheduled Operation time, min:s 45:31 (24:35) 44:18 (20:54) .80 Ranitidine use, % 48 37 .27 medication or an as-needed medication, and all patients re- Ondansetron use, %a 82 88 .63 ceived narcotics. 2-Antibiotic regimen, % 70 40 .001 Laparoscopy, % 100 97 .58 DATA COLLECTION Abscess, % 30 12 .03 Wound infection, % 2 2 .99 Demographics, admission data, hospital course, presence of medi- Time to initial feeds, d 2.7 (2.1) 1.7 (1.0) .004 cations, doses of medication, and all complications were ana- Time to full feeds, d 3.9 (2.5) 2.8 (1.2) .005 lyzed from this prospective data set. A postoperative abscess was Hospital stay, d 7.9 (4.7) 5.6 (1.3) .45 defined as an enhancing intra-abdominal fluid collection seen on computed tomographic scan obtained after postoperative day 5. SI conversion factor: To convert white blood cell count to ϫ109/L, multiply by 0.001. aWas given as ondansetron hydrochloride. COMPARISONS Multivariate analysis was performed to identify treatment vari- Table 2. Demographics and Outcomes for H Blockade ables that affected outcome. Pearson correlation was used to 2 perform this analysis. The medications identified to indepen- dently hold a significantly positive correlation to abscess de- Mean (SD) velopment were investigated directly with univariate analysis Blocked Not Blocked P to assess for differences between those who received the medi- (n = 40) (n = 58) Value cation and those who did not. The univariate comparison was done using the t test or ␹2 test to further delineate confound- Age, y 8.7 (4.5) 8.5 (4.2) .89 Յ Weight, kg 34.3 (21.4) 34.5 (21.8) .96 ing variables. Significance was defined as P .05. Descriptive Male, % 63 59 .33 statistics are listed as mean (SD). Admission white blood 0.0170 (0.0055) 0.0179 (0.0054) .46 cell count, /µL RESULTS Days of symptoms at 3.1 (2.5) 3.0 (1.7) .82 presentation Operation time, min:s 43:03 (24:37) 45:51 (20:19) .54 In the multivariate analysis, there was no correlation be- Diphenhydramine use, % 40 29 .25 tween abscess and the administration of ketorolac, nalox- Ondansetron use, %a 80 90 .29 one, or ondansetron. All patients received narcotics. Ab- 2-Antibiotic regimen, % 50 50 .99 scess rate was higher in patients who received either Laparoscopy, % 95 100 .16 Abscess, % 28 12 .047 ranitidine (P=.05) or diphenhydramine (P=.03). Corre- Wound infection, % 0 2 .99 lation of doses given and abscess rate was significant for Time to initial feeds, d 2.2 (2.0) 2.0 (1.2) .60 ranitidine (P=.003), but not diphenhydramine (P=.23). Time to full feeds, d 3.4 (2.3) 3.0 (1.3) .30 There was no correlation between the presence of di- Hospital stay, d 6.7 (3.2) 6.2 (3.0) .45 phenhydramine and the presence of ranitidine. No dif- ferences existed in patient or operative variables in those SI conversion factor: To convert white blood cell count to ϫ109/L, multiply given either medication compared with those receiving by 0.001. aWas given as ondansetron hydrochloride. no doses. Results of direct comparison by univariate analysis for 2 patients who received diphenhydramine (H1 blocked) rated appendicitis from April 2005 to November 2006. In- compared with those who did not (H unblocked) are dis- formed consent was obtained in all patients. 1 played in Table 1. Results of direct comparison for pa- tients who received ranitidine (H blocked) compared with PROTOCOL 2 those who did not (H2 unblocked) are displayed in Table 2. All patients with perforated appendicitis during this study re- ceived 5 days of intravenous antibiotics. Perforation was strictly Abscess rate in those receiving neither medication defined as a hole in the appendix or a fecalith in the abdomen. (n=41) was 10%. Those given only ranitidine (n=24) or On postoperative day 5, a white blood cell count was performed. diphenhydramine (n=17) had doubled abscess rates of 17% If this was normal, patients were discharged home without an- and 18%, respectively. Those given both medications tibiotics. If it was elevated, the patients received a minimum of 2 (n=16) had a quadrupled abscess rate of 44% (P=.03). (REPRINTED) ARCH SURG/ VOL 145 (NO. 2), FEB 2010 WWW.ARCHSURG.COM 144 ©2010 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/27/2021 COMMENT mine and doses of narcotics given prior to abscess de- tection (P=.10).
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