Corticosteroid Therapy During Endoscopic Sinus Surgery in Children: Is There a Need for a Second Look?

Objective  To determine whether intravenous administration of dexamethasone during endoscopic sinus surgery in children will decrease scarring and edema during a second-look procedure.

Design  Prospective, randomized, double-blind, placebo-controlled trial.

Setting  University medical center.

Patients  Forty-eight children undergoing endoscopic sinus surgery for chronic sinusitis.

Intervention  Twenty-four children received intravenous dexamethasone and 24 received placebo intraoperatively before the start of the procedure.

Main Outcome Measures  The status of the ethmoid cavity, the status of the mucosa in the maxillary sinuses, and the patency of the maxillary sinus ostium during the second-look procedure performed 2 to 3 weeks after the primary procedure.

Results  Children who received intravenous dexamethasone had significantly less maxillary sinus mucosal edema, less ethmoid scarring, and a lower incidence of closure of the maxillary ostium (P = .02). During the second-look procedure, 62% of children in the noncorticosteroid group had abnormal findings vs 29% in the corticosteroid group. Patients with asthma, lower computed tomography scores, and no exposure to smoking had a significantly lower incidence of scarring with use of corticosteroids. Children older than 6 years benefited from intravenous corticosteroid therapy vs children 6 years and younger.

Conclusions  Treatment with intravenous dexamethasone during endoscopic sinus surgery was safe and was helpful in reducing scarring and swelling noted during the second-look procedure. Use of corticosteroids was particularly helpful in children with asthma, lower computed tomography scores, and no exposure to smoking and in children older than 6 years.

ENDOSCOPIC sinus surgery (ESS) is one of the procedures performed on children with chronic sinusitis who have not responded to prolonged medical therapy or previous surgical procedures.¹ Postoperative care of the sinus cavities is necessary for optimal success of the procedure. In adults, the postoperative care is performed in the office; however, in most children this may not be feasible. Instead, children undergo a second-look procedure under general anesthesia 2 to 3 weeks after ESS.^1-4 The main aims of the procedure are to debride the sinus cavities of any adhesions; to remove blood clots, spacers, or packing placed during the primary procedure; and even to revise the maxillary sinus ostia.⁴ The second-look procedure has not been accepted by all otolaryngologists; in fact, recent studies⁵ suggest that a second-look procedure is unnecessary. Numerous studies, however, describe the findings at the second-look procedure and suggest that it is necessary to improve the surgical outcome of ESS.

Corticosteroids are potent anti-inflammatory agents and have been used perioperatively in an attempt to improve outcomes. They have been used in eye surgery, orthopedic surgery, and general surgery to improve wound healing.^6-8 Otolaryngologists have used corticosteroids to decrease edema in the airway, swelling after cosmetic procedures, and pain after tonsillectomy.^9,10 The purpose of this study was to determine whether administration of a single intraoperative dose of dexamethasone would have an impact on the findings of the second-look procedure.

A prospective, randomized, double-blind, placebo-controlled study was conducted with children aged 2 to 12 years (mean, 5.8 years) scheduled to undergo ESS between January 1, 1998, and October 31, 1999. Candidates for ESS were (1) all children referred to us for surgical intervention because of chronic sinusitis with continued symptoms despite prolonged and maximal medical management that included antibiotic drug use for at least 12 weeks, topical nasal corticosteroid administration, and allergy management or (2) individuals who had a previous adenoidectomy but continued to exhibit symptoms of chronic sinusitis. All children had documented sinusitis on coronal computed tomographic (CT) scans of sinuses while taking antibiotics for at least 4 weeks. Children who had previous ESS, cystic fibrosis, immunoglobulin deficiency, immotile cilia syndrome, or a contraindication to corticosteroid use were excluded from the study. Patients were randomized to receive intravenous dexamethasone (0.15-0.2 mg/kg for a maximum dose of 8 mg) or a placebo immediately before undergoing the sinus procedure. The medications were prepared by the pharmacy and were administered in a double-blind fashion. All procedures were performed under direct supervision of the author (a total of 6 senior residents participated in all surgical procedures). Standard ESS was performed as described previously.^1,4 At the end of the procedure, rolled absorbable gelatin sheet (Gelfilm) was inserted into the ethmoid cavities bilaterally (Figure 1). No additional packing or other materials were inserted into the nasal or sinus cavities. All patients were instructed not to use any nasal sprays after surgery. Patients who had purulence at the time of the procedure in their sinus cavities were given oral antibiotics for 10 days after surgery. All patients were discharged from the hospital 4 to 6 hours after undergoing the procedure. None of the patients were given any scheduled office appointments before the second-look procedure, which was performed 2 to 3 weeks after the primary ESS. At the time of the procedure, the sinus cavities were evaluated for adhesions, granulation tissue, maxillary sinus mucosal swelling, and maxillary sinus ostium–stenosis. Findings on CT were scored using the Lund-Mackay staging system.¹¹ Children with a CT score of 8 or higher were considered to be in a high stage compared with those who had a score less than 8. Statistical analysis was performed using SAS statistical software (SAS Institute Inc, Cary, NC). Univariate analysis was performed using χ² analysis for proportional variables and t tests for continuous variables; multivariate analysis was performed using logistic regression analysis. Differences were considered statistically significant at P<.05.

The study included 48 children, 28 boys and 20 girls, aged 2 to 12 years. Twenty-four patients received dexamethasone and 24 received placebo. The characteristics of both groups are detailed in Table 1. No statistical differences between the 2 groups concerning all variables, including age, sex, allergy, asthma, CT score, and smoking in the household, were noted. Children randomized to the intravenous dexamethasone group had significantly less maxillary sinus edema, less ethmoid scarring, and a lower incidence of closure of the maxillary sinus ostium. The overall findings of adhesions, swelling, and maxillary ostium narrowing on second-look procedures were seen in 22 (46%) of 48 patients. The overall incidence of abnormal findings on second-look procedures was 29% (7/24) in the corticosteroid group vs 62% (15/24) in the placebo group (Figure 2). Children with CT scores less than 8 who received corticosteroids had a 23% (3/13) incidence of abnormal findings on second-look procedures vs 62% (5/8) in children who received a placebo (P = .04) (Figure 3). There was no significant difference between children who had a high CT score: those in the corticosteroid group had a 36% (4/11) incidence of abnormal findings on second-look procedures compared with 62% (10/16) in children who took placebo (P = .2). Of children with asthma, 22% (2/9) in the corticosteroid group had abnormal findings vs 64% (7/11) in the placebo group (P = .04) (Figure 4). Of children with allergies, 18% (2/11) who received corticosteroids had abnormal findings on second-look procedures compared with 70% (7/10) in the placebo group (P = .02) (Figure 5). Of children in a nonsmoking household, 25% (4/16) who received corticosteroids had abnormal findings vs 65% (11/17) of those in the placebo group (P = .02) (Figure 6). To evaluate age and the impact of the use of corticosteroids and findings on second-look procedures, we used the mean age of 6 years as a cutoff point. Two (12%) of 16 children older than 6 years in the corticosteroid group had abnormal findings on second-look procedures compared with 10 (67%) of 15 in the placebo group (P = .02) (Figure 7). Three (38%) of 8 children aged 6 years or younger had abnormal findings on second-look procedures in the corticosteroid group compared with 5 (56%) of 9 in the placebo group (P = .2). No major complications were encountered in any of these patients during the primary or second-look procedures. Minor complications included floppy middle turbinate in 2 patients and orbital entry with orbital fat herniation in 1 patient. We did not encounter any intraoperative or postoperative bleeding. One patient had exacerbation of his asthma after surgery and required overnight hospitalization.

Endoscopic sinus surgery is a widely used procedure in the treatment of children with chronic sinusitis.^1-4,12 Its role in children seems to be promising. Postoperative care of the sinus cavity has been noted by many physicians as essential to promote long-term success.^2,3,13,14 Because in many children this cannot be done in the office, a second-look procedure is believed to be necessary for optimal success of the procedure. The small anatomic size of the nasal cavities and sinuses, and the difficult postoperative care, predispose these children to synechia formation.^4,15 Lazar et al¹⁶ reported a 43% incidence of synechia formation in children after ESS. Stankiewicz¹⁷ noted granulation tissue, synechia, scarring, and antrostomy narrowing in many children after surgery. Nayak et al¹⁴ reported a 43.5% incidence of adhesions on second-look procedures. Because of these findings, several packing and spacer materials have been suggested for use at the end of the procedure to prevent or decrease the incidence of adhesions and scarring and to maintain ostial patency. Rolled Gelfilm, dental wax, and Silastic splints have all been used.^4,13,14 Shikani¹⁸ developed a stent to be used in the middle meatal antrostomy area to keep it patent. Others¹⁹ suggested a partial middle turbinectomy to maintain patency of the ostium. Bolger et al²⁰ described the controlled synechiae technique to keep the middle turbinate medialized.

Performing a second-look procedure approximately 2 to 3 weeks after the primary ESS allows for toilet, debridement, and removal of middle meatal splints. Most authors suggest that children will greatly benefit from this procedure by having better outcomes. The most common findings at second-look procedures include granulation tissue and adhesions between the middle turbinate and the lateral nasal wall, narrowing or blockage of the middle meatal antrostomy, and swelling of the maxillary sinus mucosa.^13,16,17

Recent studies^19-21 suggest that only minimal postoperative care is required after ESS, but these studies were performed in the adult population. In a recent retrospective review¹⁶ of 94 patients who underwent ESS followed by a second-look procedure, revision surgery was necessary in 20 patients. However, in the same study, revision surgery was needed in 10 of 53 patients who did not undergo a second-look procedure. The authors concluded that because revision surgery in both groups was comparable, there was no need for a second-look procedure. However, the study was retrospective in nature, with a small number of patients and a large beta error, suggesting that lack of significance between the 2 groups might be because the authors did not include enough patients.²² Using revision surgery as the only outcome might not have been appropriate.

Injecting corticosteroids in the middle turbinates and lateral nasal wall during ESS has been advocated to decrease adhesions and scarring. However, the technique has not been widely adopted for fear of the development of blindness.

We elected to use a single dose of intravenous intraoperative dexamethasone and found a significant improvement in the incidence of granulation tissue and adhesions, maxillary mucosa swelling, and narrowing of the maxillary sinus ostium. Intravenous intraoperative corticosteroid administration has been found to be beneficial in decreasing the local inflammation. Because the second-look procedure in children requires a general anesthetic, which carries with it some morbidity and mortality, the benefit of a second-look procedure needs to be justified. Our overall incidence of positive findings on second-look procedures was 46%, which is similar to that reported in the literature.^14-17 The corticosteroid group had a 29% incidence of positive findings compared with 62% in the placebo group. Children older than 6 years benefited the most from intraoperative corticosteroid therapy: 12% developed synechia or mucosal edema with blockage compared with 67% in the placebo group. This suggests that in younger children, the small size of their anatomy will predispose them to synechia formation, swelling, and narrowing of their osteomeatal complex. Patients with asthma who received corticosteroids had a 22% incidence of abnormalities on second-look procedures compared with 64% in the placebo group. Children with allergies who received corticosteroids had an 18% incidence of abnormal findings on second-look procedures compared with 70% in the placebo group. It is an interesting finding that corticosteroid use made a difference in the postoperative findings in a group of children (asthmatics and allergics) knowing that both conditions benefit from corticosteroid use. Children with a lower CT score (<8) who receive corticosteroids had a 23% incidence of abnormal findings compared with 62% in the placebo group. This suggests that the worse the disease the more likely the findings of adhesions, swelling, and sinus blockage. Children in nonsmoking environments who received corticosteroids had a 25% incidence of abnormal findings compared with 65% in the placebo group. Those who were in a smoking environment and received corticosteroids had a 43% incidence compared with 100% in the placebo group (P = .3).

A second-look procedure after initial ESS in children has been debated recently. Physicians who are in favor of the procedure argue that it is important for the success of ESS and to obtain better outcomes. Those who are against the procedure argue that it adds morbidity to these children and that the risks may outweigh the benefits. Results of our study reveal that administration of a single intravenous dose of dexamethasone intraoperatively reduces the incidence of adhesions, maxillary sinus swelling, and maxillary sinus ostium narrowing on second-look procedures compared with placebo. This was particularly helpful in children with lower CT scores, asthma, or no exposure to smoking and in children older than 6 years. There was no added risk from the use of corticosteroids, and no complications were encountered.

Accepted for publication August 11, 2000.

Presented in part at the Eastern Section Meeting, Pittsburgh, Pa, January 30, 2000.

Corresponding author and reprints: Hassan H. Ramadan, MD, MSc, Department of Otolaryngology–Head and Neck Surgery, West Virginia University, PO Box 9200, Morgantown, WV 26506-9200 (e-mail: hramadan@hsc.wvu.edu).