Hematologic and economic impact of aprotinin in reoperative pediatric cardiac operations

BACKGROUND: Aprotinin consistently reduces blood loss and transfusion requirements in adults during and after cardiac surgical procedures, but its effectiveness in children is debated. We evaluated the hemostatic and economic effects of aprotinin in children undergoing reoperative cardiac procedures with cardiopulmonary bypass. METHODS: Control, low-dose aprotinin, and high-dose aprotinin groups were established with 15 children per group. Platelet counts, fibrinogen levels, and thromboelastographic values at baseline and after protamine sulfate administration, number of blood product transfusions, and 6-hour and 24-hour chest tube drainage were used to evaluate the effects of aprotinin on postbypass coagulopathies. Time needed for skin closure after protamine administration and lengths of stay in the intensive care unit and the hospital were recorded prospectively to determine the economic impact of aprotinin. RESULTS: Coagulation tests performed after protamine administration rarely demonstrated fibrinolysis but did show significant decreases in platelet and fibrinogen levels and function. The thromboelastographic variables indicated a preservation of platelet function by aprotinin. Decreased blood product transfusions, shortened skin closure times, and shortened durations of intensive care unit and hospital stays were found in the aprotinin groups, most significantly in the high-dose group with a subsequent average reduction of nearly $3,000 in patient charges. CONCLUSIONS: In children undergoing reoperative cardiac surgical procedures, aprotinin is effective in attenuating postbypass coagulopathies, decreasing blood product exposure, improving clinical outcome, and reducing patient charges.     

Prospective randomized placebo-controlled trial of aprotinin for elective aortic reconstruction

BACKGROUND: The serine protease antagonist, aprotinin, reduces perioperative blood loss in cardiac surgery and orthotopic liver transplantation. A pilot study suggested that the drug may also reduce bleeding during infrarenal aortic replacement; the aim was to confirm or refute this observation with a prospective, randomized, double-blind, placebo-controlled trial. METHODS: Some 136 patients were randomized to receive either aprotinin, given as a loading dose of 2 x 10(6) kallikrein inactivator (KI) units followed by 0.5 x 10(6) KI units/h or equal volumes of 0.9 per cent saline. After 80 patients had been randomized the infusion dose was doubled to ensure that plasma levels were similar to those seen in successful cardiac studies. Blood loss, coagulation and haematological parameters were recorded throughout surgery and for 7 days afterwards. Blood was transfused to maintain the haemoglobin level at 100 g/l. RESULTS: Four patients were withdrawn after randomization when found at laparotomy to be unsuitable for the planned reconstruction. The 30-day mortality rate was 4.5 per cent, with no excess complications in either group. Blood loss collected on swabs was reduced from 480 ml in placebo-treated patients to 379 ml with aprotinin (P = 0.014). Blood loss into suction drains in the first 24 h after operation was reduced from 295 to 205 ml in aprotinin-treated patients (P = 0.002). However, no significant reduction was found in intraoperative or total blood loss, or transfusion requirement. CONCLUSION: The small reduction in blood loss in patients treated with aprotinin demonstrated in this study does not support its use in routine elective aortic surgery.     

Risks of repeat sternotomy in pediatric cardiac operations

BACKGROUND: Repeat sternotomy has been associated with increased perioperative risks. METHODS: We reviewed 165 patients undergoing 192 repeat sternotomies between January 1985 and January 1997 (group 1) and a control group of 184 patients (group 2). The operations in group 1 were valve procedures in 94 patients, Fontan procedure in 46, ventricular septal defect closure in 10, pulmonary arterioplasty in 17, and others in 25; in group 2 ventricular or atrial septal defect closure in 120 patients, tetralogy of Fallot repair in 26, valve procedures in 16, bidirectional Glenn anastomosis in 7, repair of transposition of the great arteries in 7, pulmonary arterioplasty in 4, and others in 4. RESULTS: The hospital mortality was 2.6% in group 1 and 3.8% in group 2. Cardiac laceration occurred in 10 of 192 patients (5.2%), requiring emergent femorofemoral bypass in 6 patients. Two patients sustained an air embolism that was successfully treated with a hyperbaric chamber. Median total blood loss and requirements were not significantly different between the two groups. The length of stay in the intensive care unit and in the hospital were 4 days (range, 1 to 80 days) and 11 days (range, 1 to 135 days) in group 1, and 2 days (range, 1 to 87 days) and 7 days (range, 1 to 131 days) in group 2 (p < 0.02 and p < 0.002, respectively). The rate of complications was not significantly different in group 1 versus group 2. Overall survival was 97% (group 1) and 95% (group 2) at 120 months' follow-up (not significant). CONCLUSIONS: With careful surgical technique and judicious use of femorofemoral bypass, the risk of repeat sternotomy is minimized.     

Dexamethasone decreases the incidence of shivering after cardiac surgery: a randomized, double-blind, placebo-controlled study

Shivering after cardiac surgery is common, and may be a result of intraoperative hypothermia. Another possible etiology is fever and chills secondary to activation of the inflammatory response and release of cytokines by cardiopulmonary bypass. Dexamethasone decreases the gradient between core and skin temperature and modifies the inflammatory response. The goal of this study was to determine whether dexamethasone can reduce the incidence of shivering. Two hundred thirty-six patients scheduled for elective coronary and/or valvular surgery were randomly assigned to receive either dexamethasone 0.6 mg/kg or placebo after the induction of anesthesia. All patients received standard monitoring and anesthetic management. After arrival in the intensive care unit (ICU), nurses unaware of the treatment groups recorded visible shivering, as well as skin and pulmonary artery temperatures. Analysis of shivering rates was performed by using chi2 tests and logistic regression analysis. Compared with placebo, dexamethasone decreased the incidence of shivering (33.0% vs 13.1%; P = 0.001). It was an independent predictor of reduced incidence of shivering and was also associated with a higher skin temperature on ICU admission and a lower central temperature in the early postoperative period. IMPLICATIONS: Dexamethasone is effective in decreasing the incidence of shivering. The effectiveness of dexamethasone is independent of temperature and duration of cardiopulmonary bypass. Shivering after cardiac surgery may be part of the febrile response that occurs after release of cytokines during cardiopulmonary bypass.     

Topical use of aprotinin in open heart operations

Among various pharmacological agents used to reduce bleeding after open-heart operations, high-dose aprotinin therapy seems most promising. However, its long-term effects are still obscure; there is almost always possibility of bypass graft occlusions produced by the hypercoagulable state induced by aprotinin in coronary bypass operations. Topical application of aprotinin into the pericardial cavity could prevent the adverse effects. Fifty patients were prospectively studied to evaluate the effects of topical aprotinin. One million KIU of aprotinin was poured into the pericardial cavity before closure of the sternotomy in group 1 (n = 25). Patients in group 2 (n = 25) served as controls. Total postoperative bleeding was significantly reduced in group 1 when compared with that of group 2 (722.7 +/- 230.8 versus 1,282.6 +/- 225.7 mL; p < 0.01). The use of banked donor blood products was significantly less in group 1 than in group 2 (0.33 +/- 0.67 versus 1.36 +/- 0.86 units; p < 0.01). These results show that topical use of aprotinin reduces post-operative blood loss and need for transfusion. It seems promising and warrants further studies to be done.     

A pilot double-blind, randomized, and placebo-controlled study of orally administered IFN-alpha-n1 (Ins) in pediatric patients with measles

OBJECTIVE: To describe the effect of infection control interventions on the incidence of vancomycin-resistant enterococci (VRE), the utility of pharyngeal cultures for surveillance for VRE colonization, and the cost of barrier precautions. DESIGN: Evaluation of the occurrence of VRE infection or colonization, rates of vancomycin use, results of surveillance cultures before and after interventions, and the cost of increased barrier precautions. SETTING: University of Massachusetts Medical Center, a 347-bed tertiary-care teaching hospital with eight intensive-care units, one burn unit, and one bone marrow transplant unit. PARTICIPANTS: Patients in the intensive-care units and staff who were involved with patients colonized or infected with VRE. METHODS: Infection control interventions included placement of patients with VRE in private rooms, strict contact isolation, cohorting of patient and nursing staff, prohibiting of equipment sharing, and monitoring of compliance with the vancomycin restriction policy, with hand washing, and of the adequacy of environmental cleaning. Both rectal and pharyngeal cultures were obtained from patients at the beginning of the outbreak, and the utility of pharyngeal cultures was evaluated. The cost of barrier precautions was estimated by comparing the cost of glove and gown use before and after the outbreak began. RESULTS: The interventions decreased the number of new cases of VRE, but total eradication of VRE was not achieved. Compliance with the room-cleaning protocol was 91% (141/155 observations). Hand washing following interaction with patients who were not in isolation was 51%, vs 100% for patients in isolation. Overall, handwashing compliance was 71% (319/449): 56% (130/231) for physicians and 86% (187/218) for nurses (P<.0001). The mean number of doses of vancomycin dispensed per 1,000 patient days decreased from 145 to 114 per 1,000 patient days (P<.001). Compliance with vancomycin-use guidelines was 85%. Forty-six (77%) of 60 surveillance rectal swabs yielded enterococci, as compared to only 4 (11%) of 36 pharyngeal cultures (P<.0001). Expenses on glove and gowns alone increased by over $11,000 per year since the epidemic began. CONCLUSIONS: Implementation of the various infection control measures did not eradicate VRE cases from the hospital. Rectal cultures were more useful than pharyngeal cultures for surveillance of VRE. Controlling VRE epidemics can be costly.     

Bromocriptine in systemic lupus erythematosus: a double-blind, randomized, placebo-controlled study

The objective of this study was to investigate the efficacy and safety of bromocriptine (BRC) as an adjunct to conventional treatment in systemic lupus erythematosus (SLE). A prospective, double-blind, randomized, placebo-controlled study compared BRC at a fixed daily dosage of 2.5 mg with placebo. Patients were followed for 2-17 months (mean 12.5 months). Disease activity was assessed using the SLE Disease Activity Index (SLEDAI), numbers of flares were recorded, and serum prolactin (PRL) levels were obtained at intervals during the study. Patients were allowed to take prednisone and immunosuppressive drugs. Sixty-six patients with SLE entered the study. Thirty-six were treated with BRC, and 30 controls received placebo. Sixteen patients were removed from the study during the treatment period: five in each group left the study because of adverse effects, five became pregnant, and one patient who took placebo died with central nervous system lupus. Four patients in the BRC treatment group and three patients in the placebo group moved away or stopped coming for study visits for unknown reasons, and were lost to follow-up during the course. At entry, serum PRL was (mean+/-s.d.) 24.8 ng/ml+/-18.4 in the BRC treatment group. This value fell to 5.8+/-9.0 after 12 months of treatment. Corresponding PRL values in controls were 23.7+/-22.1 pretreatment and 20.3+/-14 after 12 months. PRL levels in BRC-treated subjects were significantly lower than levels in control subjects after 3, 6, 9, and 12 months of treatment. The SLEDAI score on the fifth protocol visit was decreased significantly in the BRC group vs controls: 0.9+/-1.4 vs 2.6+/-4.5 (P < 0.05). Although the absolute number of flares in each group was similar, the mean number of flares/patient/month was decreased significantly in the BRC group compared to the control group (0.08+/-0.1 vs 0.18+/-0.2, P = 0.03). Long term treatment with a low dose of BRC appears to be a safe and effective means of decreasing SLE flares in SLE patients.     

Effect of a local nonsteroidal anti-inflammatory drug on postoperative irritation after squint surgeries. Prospective randomized double-blind study

BACKGROUND: Topical application of a nonsteroidal antiphlogistic drug (NSAD) is often recommended to minimize postoperative lid and conjunctival edema. However, the effectiveness of such therapy remains controversial. PATIENTS AND METHODS: The study presented included 100 patients aged 23.6 +/- 19.5 (5 to 77) years, who were randomly assigned to two treatment groups. Group 1 included 50 patients who underwent squint surgery, and who received Flurbiprofen ED twice a day from the first preoperative day to the third postoperative day. Group 2 served as a control group. These patients were treated with the same regimen using artificial tears. The extent of lid and conjunctival edema was assessed and scored from 1 to 4 on the fourth postoperative day. RESULTS: Squint surgery was performed on 129 eyes of 100 patients. In 32 eyes (24.8%) one muscle was operated on. In 79 eyes (61.2%) 2 muscles and in 18 eyes (14%) three muscles were operated on. The average postoperative conjunctival edema score was 2.08 +/- 0.62 (Flurbiprofen group) and 2.04 +/- 0.67 (control group), respectively. The scoring values for lid edema were 1.90 +/- 0.54 and 1.82 +/- 0.43. The differences between the two groups were not statistically significant (P = 0.21 and 0.39; Mann-Whitney test). No influence of the patient's age on the development of lid and conjunctival edema could be detected (P > 0.08). However, the number of muscles that were operated on had a significant influence on both parameters (P = 0.01 and 0.028). Single muscle operations revealed the lowest scaling values (P < 0.02 and P < 0.04). No difference was found whether 2 or 3 muscles were operated on (P = 0.24 and 0.12). CONCLUSIONS: No beneficial effect of topical application of NSAD on postoperative lid and conjunctival edema could be found in this controlled study.     

Fibrinolysis-adjusted perioperative low-dose aprotinin reduces blood loss in bypass operations

BACKGROUND: Postoperative bleeding still remains a serious problem in bypass surgery. This study evaluated fibrinolysis and perioperative low-dose antifibrinolytic regimens adjusted to the time course of fibrinolysis. METHODS: In a prospective, randomized study of 42 patients undergoing bypass grafting, patients received low-dose aprotinin (group A; n = 14) or low-dose tranexamic acid (group TA; n = 14) intraoperatively and postoperatively, respectively, with no antifibrinolytics for comparison (group C; n = 14). Parameters of procoagulation, fibrinolysis, and activated factor VII were measured preoperatively, intraoperatively, and postoperatively. Blood loss was determined up to 24 hours. RESULTS: The level of thrombin-antithrombin III complex was significantly decreased postoperatively in the treatment groups (group A and TA versus C: 25 +/- 14 and 19 +/- 10 microg/L, respectively, versus 40 +/- 21 microg/L; p < 0.05). Levels of plasmin-antiplasmin complexes were significantly decreased postoperatively in group A (607 +/- 231 microg/L) versus group C (825 +/- 225 microg/L) (p < 0.05) but were increased in group TA (1,145 +/- 394 microg/L) versus group C (p < 0.05). At all times intraoperatively and postoperatively, levels of D-dimers were significantly decreased in group A and group TA versus control (p < 0.001), indicating that fibrinolysis persists after the operation. Intraoperatively, the factor VIIa level decreased significantly in group A (20 +/- 8 mU/mL) versus group C (31 +/- 15 mU/mL) (p < 0.05), but not in group TA (32 +/- 15 mU/mL). Blood loss was significantly lower in group A (135 +/- 37 mL) and group TA (155 +/- 71 mL) versus group C (354 +/- 170 mL) (p < 0.001). CONCLUSIONS: This low-dose aprotinin regimen adjusted to perioperative fibrinolysis reduces blood loss significantly in coronary bypass grafting. For further progress in this subject, clinical investigations of individual fibrinolysis-adjusted antifibrinolytic treatment seems warranted.     

Peritoneal and subcutaneous administration of cefazolin as perioperative antibiotic prophylaxis in colorectal operations. Prospective randomized comparative study of 200 patients

The prophylactic effect of a intraoperative intraperitoneal and subcutaneous application of cefazolin versus a single shot i.v. prophylaxis was investigated. Additionally, we registered the concentration of cefazolin in the serum and the peritoneal fluid in 22 patients. We randomized 200 patients of whom 189 were included in the study. Ninety-two patients received the prophylaxis i.v. (group 1) and 97 topically (group 2). In 4 (2.1%) wound infections occurred [3(3.3%) group 1 and 1 (1.0%) in group 2]. The difference was not significant. The concentration of cefazolin in the serum was significantly higher at 1 h and 2 h postoperatively in group 2. We conclude that a topical application of antibiotics is possible to prevent surgical wound infection.     

Corticosteroids in the treatment of tuberculous pleurisy. A double-blind, placebo-controlled, randomized study

Although several studies on tuberculous (TB) pleurisy suggest that the addition of corticosteroids to anti-TB therapy may have beneficial effects, these agents are not used routinely. To assess the effects of short-term oral prednisone therapy in TB pleurisy, 74 patients were randomly assigned in a double-blind fashion to treatment with either placebo or prednisone at a dose of 0.75 mg/kg/d for up to 4 weeks with gradual reduction over an additional 2 weeks. All subjects received a standard 3-drug anti-TB chemotherapy regimen for 6 months. TB pleurisy was diagnosed by histologic study and/or culture of pleural biopsy specimens obtained at thoracoscopy. Complete drainage of the effusion was performed simultaneously. Outcome measures were assessed periodically for 24 weeks, including indexes of morbidity and pleural thickening. After randomization, four patients were excluded from the final analysis. Of the 70 patients analyzed, 34 received prednisone and 36 received placebo. Demographic and clinical characteristics of the treatment groups were comparable at the time of hospital admission. Although a statistically significant improvement in symptoms occurred earlier in the prednisone group (8 weeks) than in the placebo group (12 weeks), between-group comparison showed no significant differences at any of the follow-up evaluations. The proportion of subjects in the prednisone group (53.1%) with residual pleural thickening at 6 months did not differ significantly from that of the placebo group (60%). Pleural effusions did not recur in any of the patients. Initial complete drainage of the effusion was associated with greater symptomatic improvement than any subsequent therapy. We conclude that standard anti-TB therapy and early complete drainage is adequate for the treatment of TB pleurisy. The addition of short-term oral prednisone therapy neither results in clinically relevant earlier symptom relief nor confers a beneficial effect on residual pleural thickening.     

A double-blind, randomized study of naproxen sodium, ibuprofen, and placebo in postoperative dental pain

In a double-blind, parallel, placebo-controlled study, 203 patients with post-operative dental pain following the extraction of one or two bony impacted third molars were randomized to receive a single dose of naproxen sodium 220 mg, ibuprofen 200 mg or placebo. Pain intensity and pain relief were assessed at intervals for 12 hours postdose. Both active drugs demonstrated superior analgesic efficacy over placebo. Naproxen sodium and ibuprofen were comparable both in onset of analgesic action and in pain relief. From 1 to 12 hours postdose, naproxen sodium showed a trend for superior analgesic efficacy compared with ibuprofen; this trend reached statistical significance at the 12-hour time point. Both drugs were well-tolerated and effective analgesics for postoperative dental pain.     

Clonidine for major vascular surgery in hypertensive patients: a double-blind, controlled, randomized study

The utility of clonidine for hypertensive patients presenting for major vascular procedures remains debatable. Twenty-one hypertensive patients presenting for aortic surgery were given clonidine (n = 11) or placebo (n = 10) in a double-blind, randomized manner. Clonidine was administered 6 micrograms/kg per os 120 min before induction of anesthesia and 3 micrograms/kg intravenously (i.v.) over 60 min from aortic declamping to skin closure. Anesthesia was induced with alfentanil 20 micrograms/kg, midazolam, and atracurium and maintained with nitrous oxide 70%, an alfentanil infusion (0.25 microgram.kg-1. min-1), and isoflurane. Anesthetic requirements, circulatory variables, interventions, and isoproterenol dose-response curves (pre- and postoperatively) were determined. Plasma concentrations of clonidine, alfentanil, and vasoactive hormones were measured. When the clonidine group was compared with the placebo group, (a) isoflurane, alfentanil, and midazolam requirements were reduced by 38%, 42%, and 41%, respectively (P = 0.04, 0.03, 0.0002, respectively); (b) supplemental circulatory and anesthetic adjustments were reduced by 51% (P = 0.0006); (c) interventions with vasopressors were not significantly increased (placebo: two; clonidine: five); (d) systolic and mean arterial pressures and heart rate were reduced; (e) increases in norepinephrine, epinephrine, and plasma renin activity were suppressed, whereas vasopressin surge was attenuated; and (f) chronotropic response to isoproterenol was unaffected. Clonidine was effective in reducing anesthetic requirements and in improving circulatory stability in hypertensive patients presenting for major vascular procedures.     

The benefits of active rewarming after cardiac operations: a randomized prospective trial

Studies were carried out to observe the species composition of mosquitos and to determine the vectors responsible for the transmission of filariasis in Grik, Perak, Malaysia. A total of 2,155 mosquitos belonging to 7 genera and 30 species were collected. Anopheles donaldi comprised 24.1% of the collection. Twelve out of 519 An. donaldi were infected with L3 larvae of Brugia malayi. The peak biting time was around 23.00-24.00 hours. The infective bites per month ranged from 0 to 6.3.     

Oral delivery of anticoagulant doses of heparin. A randomized, double-blind, controlled study in humans

BACKGROUND: Parenteral heparin is the anticoagulant of choice in hospitalized patients. Continued anticoagulation is achieved by subcutaneous administration of low-molecular-weight heparin or with an orally active anticoagulant such as warfarin. An oral heparin formulation would avoid the inconvenience of subcutaneous injection and the unfavorable drug interactions and adverse events associated with warfarin. A candidate delivery agent, sodium N-[8(-2-hydroxybenzoyl)amino]caprylate (SNAC), was evaluated with escalating oral heparin doses in a randomized, double-blind, controlled clinical study for safety, tolerability, and effects on indexes of anticoagulation. METHODS AND RESULTS: Increases in activated partial thromboplastin time (aPTT), anti-factors IIa and Xa, and tissue factor pathway inhibitor (TFPI) concentrations were detected when normal volunteers were dosed with 10.5 g SNAC/20000 IU heparin by gavage in some subjects. For the entire group, 30000 IU SNAC and heparin elevated TFPI from 74.9+/-7.6 to 254.2+/-12.3 mg/mL (P<0.001) 1 hour after dosing (P<0.001). Similar changes occurred in anti-factor IIa and anti-factor Xa. aPTT rose from 28+/-0.5 to 42.2+/-6.3 seconds 2 hours after dosing (P<0.01). No significant changes in vital signs, physical examination, ECGs, or clinical laboratory values were observed. Neither 30000 IU heparin alone nor 10.5 g SNAC alone altered the hemostatic parameters. Emesis was associated with 10.5 g SNAC. A taste-masked preparation of SNAC 2.25 g was administered orally with heparin 30000 to 150000 IU. Both aPTT and anti-factor Xa increased with escalating doses of heparin. This preparation was well tolerated. Conclusions-Heparin, administered orally in combination with the delivery agent SNAC, produces significant elevations in 4 indexes of anticoagulant effect in healthy human volunteers. These results establish the feasibility of oral delivery of anticoagulant doses of heparin in humans and may have broader implications for the absorption of macromolecules.     

The prophylactic effect of aprotinin on intraoperative bleeding in liver transplantation: a randomized clinical study

Fibrinolysis has been recognized as an important cause of intraoperative bleeding during orthotopic liver transplantation (OLT). Several investigators have used prophylactic administration of aprotinin in patients to inhibit fibrinolysis and to decrease transfusion requirements, morbidity, and mortality. Nevertheless, the role of aprotinin in this situation is not yet clear. The goal of this study was to determine the effects of prophylactic administration of aprotinin on intraoperative bleeding and blood requirements, and on hemostatic changes during OLT. Eighty consecutive patients were included in a double-blind, prospective study and were randomized in two groups. In group A (n = 39), an initial dose of 2 x 10(6) kallikrein inactivator units (KIU) of aprotinin was administered in the induction of anesthesia followed by infusion of 5 x 10(5) KIU/h until the end of the procedure. The control group (n = 41) received an identical volume of saline solution. The majority of the operations were performed with vena cava preservation (piggy-back technique) without venovenous bypass. During the anhepatic phase, a significant increase in levels of tissue plasminogen activator, thrombin-antithrombin complexes (TAT) and D-dimers (DD) was noted in both groups. A significant increment of TAT was observed in group A during reperfusion. The remaining hemostatic parameters were similar in both groups. Intraoperative requirements of packed red cells, fresh-frozen plasma (FFP), platelets, and cryoprecipitate were similar in the two groups. Our results suggest that prophylactic administration of aprotinin is not useful in reducing bleeding and blood product requirements during OLT.     

Hemostasis and blood requirements in orthotopic liver transplantation with and without high-dose aprotinin

Immunization is a safe and cost-effective method to protect adult patients against many diseases, including hepatitis B, pneumococcal infections, and influenza. Despite this fact, only 10% to 40% of adults in the United States who would benefit have been immunized. Approximately 62% to 92% of patients who develop a disease preventable by vaccination have visited an outpatient clinic at least once in the 3 years preceding their illness. Efforts to educate providers about immunization guidelines have not increased immunization rates. In this report, we propose using the preanesthesia clinic as an alternative site to screen, identify, and immunize adults at risk. We also discuss three vaccines that could be offered to patients and analyze the efficacy of the vaccines.     

A prospective, double-blind, randomized study of the effects of perioperative steroids on palatoplasty patients

OBJECTIVE: To determine whether perioperative steroids affect the outcome of patients who undergo palatoplasty. DESIGN: A prospective, double-blind, randomized study. SETTING: A university medical center. PATIENTS: Twenty patients undergoing primary repair of a cleft palate. INTERVENTION: A prospective double-blind technique was used to randomly assign patients to receive a placebo or dexamethasone sodium phosphate perioperatively. MAIN OUTCOME MEASURE: Patients were monitored for postoperative airway distress, fever, oral fluid intake, days of hospitalization, and wound healing. RESULTS: The use of perioperative steroids was associated with shorter hospitalizations. No adverse sequelae from the administration of steroids were identified. CONCLUSIONS: In our current managed care environment, the use of perioperative steroids may play an important role in reducing health care costs.