Purpose
To evaluate the role of oral corticosteroids as an anti-inflammatory adjunct in the treatment of orbital cellulitis.
Design
Prospective, comparative, single-masked, interventional clinical study.
Methods
setting : Tertiary eye care center (All India Institute of Medical Sciences). study population : Patients with acute onset (within 14 days) of orbital cellulitis with or without abscess. intervention : Patients were randomized into 2 groups in the ratio of 1:2. Both groups received initial intravenous antibiotics. In Group 2, oral steroids were added after an initial response to intravenous antibiotics. main outcome measures : Resolution of signs and symptoms, duration of intravenous antibiotics, length of hospital stay, and sequelae of disease (ptosis, proptosis, and movement restriction) were evaluated and compared between the 2 groups.
Results
A total of 21 patients (age range, 11-59 years) with orbital cellulitis were studied. There were 7 patients in Group 1, who received standard intravenous antibiotics, and 14 in Group 2, who received adjuvant steroids. Patients in Group 2 showed an earlier resolution of inflammation in terms of periorbital edema ( P = .002 at day 7), conjunctival chemosis ( P < .001 at day 10), and pain ( P = .012 at day 7). They also attained vision of 0.02 on logMAR earlier than Group 1 patients. Decrease in proptosis and improvement in extraocular movements were also significantly better with the use of steroids ( P = .027 at day 10, P = .003 at day 14, respectively). While a significant number of patients in Group 1 had mild residual ptosis, proptosis, and movement restriction at 12 weeks, none of the patients treated with steroids had any residual changes ( P = .023, P = .001, and P = .001, respectively). The durations of intravenous antibiotics and hospital stay were significantly less in Group 2.
Conclusion
Use of oral steroids as an adjunct to intravenous antibiotic therapy for orbital cellulitis may hasten resolution of inflammation with a low risk of exacerbating infection.
Acute orbital cellulitis attributable to bacterial infection is associated with diffuse edema of the orbital tissues with infiltration by inflammatory cells. It is a potentially sight- and life-threatening condition. Permanent visual loss has been reported in 11% to 26% of cases. This results from panophthalmitis or compressive optic neuropathy attributable to raised intraorbital pressure or toxic optic neuritis or due to exposure keratopathy following proptosis. Intracranial complications, “though rare,” include meningitis (2.1%), brain abscess, subdural empyema, and cavernous sinus thrombosis(19.2%).
The standard management of acute-onset orbital cellulitis is to start a combination of intravenous broad-spectrum antibiotics along with treatment of associated sinusitis, if present. Surgical drainage of the abscess is done, when necessary. Though this effectively controls the infective component, inflammation may persist for weeks to months after infection.
As the orbit represents a nearly closed compartment with limited space, elevated orbital pressure as a result of inflammation is the primary and potentially reversible mechanism of visual impairment in most cases of orbital cellulitis. By reducing edema and cell migration and inhibiting the toxic effects of cytokines and other mediators, corticosteroids can decrease the compression on orbital structures. Moreover, by decreasing fibroblast proliferation, they can reduce scarring and potential long-term sequelae.
Although there are many theoretical advantages for the adjunctive use of corticosteroids, their role in orbital cellulitis is not clear. On review of English literature, we found 1 study evaluating the role of corticosteroids in acute management of orbital cellulitis. In this retrospective study, the authors concluded that the use of corticosteroids does not adversely affect clinical outcome and may be beneficial in treatment of pediatric orbital cellulitis with subperiosteal abscess.
We conducted a prospective, randomized, comparative clinical study to evaluate the role of oral corticosteroids in the management of orbital cellulitis. The purpose of the study was to evaluate if addition of corticosteroids could lead to earlier resolution of inflammation and improve functional outcome. We excluded children in our study as this was a pilot study and the role of steroids in cellulitis is not established.
Methods
Eligible Patients
This was a prospective, comparative, single-masked, interventional clinical study. The study protocol was approved by the All India Institute of Medical Science’s Ethical Committee. Informed written consent to participate in this study was obtained from all patients.
Patients with acute onset (within 14 days) of orbital cellulitis were enrolled over a period of 18 months (August 2007 – January 2009). Children less than 10 years of age were excluded. Patients with suspected fungal or tubercular orbital infections, those not responding to standard treatment, or those having received intravenous antibiotics or who were pregnant were also excluded. On admission, after a detailed history and clinical examination, baseline investigations including hemogram, liver and renal function tests, blood sugar, blood culture, urine microscopy and culture, chest radiograph, and temperature charting were carried out. Computed tomography of the head and orbit was performed to document and stage the infection. Ultrasonography of the orbit was done to look for the resolution of abscess.
Treatment Protocol
All patients were classified into 1 of the 5 groups originally described by Chandler and associates. All patients were initially started on standard treatment of intravenous vancomycin (1 g twice a day or 40 mg/kg/day in 2 divided doses) and intravenous ceftriaxone (1 g twice a day or 100 mg/kg/day in 2 divided doses). In cases not responding within 48 hours or where anaerobic foci were suspected, intravenous metronidazole (500 mg 3 times a day or 30 mg/kg/day in 3 divided doses) was added. Concomitant sinusitis, if present, was treated. Surgical drainage was done as and when required and pus was sent for cultures. Supportive treatment in the form of topical antibiotics and lubricants was started.
After an initial response to antibiotics, the patients were randomized into 2 groups (using a random number generator). Patients in Group 1 were continued on the standard treatment. Patients in Group 2 received adjuvant oral prednisolone starting from day 4 to day 7 in addition to standard treatment. The starting dose was 1.5 mg/kg/day for 3 days followed by 1 mg/kg/day for another 3 days. The steroids were then tapered and stopped within the next 1 to 2 weeks. After significant response to treatment, patients were shifted onto oral antibiotics and discharged on the third day. Patients with abscess were discharged when no collection was found on ultrasound.
Parameters Assessed
The clinical parameters evaluated were pain, fever, periorbital edema, conjunctival chemosis, vision (logMAR values), proptosis (measured by Hertel exophthalmometer), and extraocular movements.
Pain was assessed by visual analogue scale (VAS), which is a 0-to-10 scale for pain intensity (0 is no pain and 10 is extreme pain). The grading of pain was done as: grade 5: extreme pain with VAS score of 10; grade 4: severe pain with VAS score of 7 to 9; grade 3: moderate pain with VAS score of 5 or 6; grade 2: mild pain with VAS score of 3 or 4; grade 1: no to faint sensation with VAS score of 0 to 2.
Periorbital edema was graded on a scale of 0 to 4, as follows: grade 4: very severe swelling, very difficult to separate the eyelids; grade 3: severe swelling, eyelids can be separated with some difficulty; grade 2: moderate swelling, patient can separate eyelids by himself or herself; grade 1: mild swelling, patient can easily open eyelids with no difficulty; grade 0: no swelling.
Conjunctival chemosis was graded on a scale of 0 to 3: grade 3: conjunctival congestion with prolapse; grade 2: in between grade 3 and grade 1; grade 1: minimal congestion with faintly detectable conjunctival edema; grade 0: no chemosis.
Extraocular movement was measured by the Kestenbaum limbus test of motility. Movement of limbus was measured in all 4 directions (superior, inferior, lateral, and medial) using a ruler and recorded in millimeters, for both eyes. The sum of all values was calculated and this value was compared with the other eye. For movement in percentage, the movement in the affected eye was compared with the normal eye.
The analysis of parameters was done for the data collected on the day of admission; on days 3, 7, 10, and 14; and on the 12th week (final) using the Mann-Whitney test, Student t test, and Fisher exact test. A P value < .05 was considered significant.
Results
Demographic and Clinical Features
A total of 21 patients were enrolled and randomized into 2 groups: 7 in Group 1 and 14 in Group 2 (cases treated with adjuvant oral steroids). Overall, the male-to-female ratio was 5:2. One patient in Group 2 had bilateral involvement. The average age in Group 1 was 22.6 ± 18.6 years and in Group 2 was 22.9 ± 11.2 years. The mean duration of illness at presentation was 7.4 ± 2.8 days in Group 1 and 7.9 ± 5.1 days in Group 2. Orbital cellulitis with abscess (stage 4) was the most common presentation (12 of 22 eyes, 55%; 3 in Group 1 and 9 in Group 2), followed by cellulitis without abscess (stage 2, 7 of 22 eyes, 32%; 3 in Group 1 and 4 in Group 2) and cellulitis with subperiosteal abscess (stage 3, 3 of 22 eyes, 14%; 1 in Group 1 and 2 in Group 2). The distribution of cases in different stages of cellulitis in both groups was statistically comparable.
Sinusitis was the most common predisposing factor (4 patients in Group 1 and 5 patients in Group 2). Others were local periorbital infections (1 patient in Group 1 and 5 patients in Group 2), trauma (2 patients in each group), and odontigenic infection (1 patient in Group 1). Out of 21 patients, blood culture was positive in 5 patients (23.8%; 2 in Group 1 and 3 in Group 2); 2 Staphylococcus aureus , 2 Streptococcus epidermidis , and 1 Kleibsiella sp.
Treatment
All patients were started on intravenous antibiotics, with intravenous metronidazole given in 6 patients (2 in Group 1 and 4 in Group 2). In Group 2, oral steroids were started from the fourth day onward (mean ± SD of 5.13 ± 0.84 days). Surgical drainage was required in a total of 3 patients (1 in Group 1 and 2 in Group 2) and pus culture grew S epidermidis in 2 patients (1 in each group) and Escherichia coli in 1 patient (Group 2). The mean duration for intravenous antibiotics was 11.6 ± 4.6 days in Group 1 and 8.6 ± 1.3 days in Group 2 ( P = .013). In Group 2, steroids were given for a mean duration of 15.8 days (range, 14-21 days). The mean duration of hospital stay was 18.4 ± 5.9 days in Group 1 and 14.1 ± 3.7 days in Group 2 ( P = .02).
Response Analysis
All patients were febrile on day 0. Patients in Group 2 became afebrile earlier than in Group 1 and the difference was significant on days 7, 10, and 14 of treatment ( P = .03, P = .02, P = .04, respectively). On admission, most of the patients in both the groups had a pain score of 10 on VAS. On comparing the grading of pain in both groups, pain was of lesser intensity in Group 2 at day 7 ( P = .01), though the difference was not significant on day 10. Periorbital edema was comparable at baseline in the 2 groups. Three patients in Group 1 and 7 in Group 2 had edema of grade 4 severity on day 0. On day 7, in Group 1, all patients had edema including 1 patient with grade 3 edema and 4 with grade 2 edema. In contrast, in Group 2, 10 patients had grade 1 edema and 5 had no edema. Moreover, 13 eyes in Group 2 had no edema as compared to only 1 in Group 1 by day 10. Hence, edema resolved earlier in Group 2 ( P = .002 on days 7 and 10). Similarly, at baseline, 2 patients in Group 1 and 8 in Group 2 had grade 3 conjunctival chemosis. By day 10, while 4 patients in Group 1 had edema of grade 1 severity, none of the patients in Group 2 had chemosis ( P = .0006). However, by day 14 none of the patients in either group had chemosis ( Table 1 ).
| Pain | Conjunctival Chemosis | Periorbital Edema | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade | Group 1 (n) | Group 2 (n) | P Value a | Grade | Group 1 (n) | Group 2 (n) | P Value a | Grade | Group 1 (n) | Group 2 (n) | P Value a | |
| Day 0 | 4 | 1 | 5 | .349 | 1 | 1 | 2 | .586 | 2 | 1 | 2 | >.000 |
| 5 | 6 | 10 | 2 | 4 | 5 | 3 | 3 | 6 | ||||
| 3 | 2 | 8 | 4 | 3 | 7 | |||||||
| Day 3 | 2 | 2 | 3 | .536 | 1 | 1 | 6 | .210 | 1 | 0 | 2 | 1.00 |
| 3 | 2 | 7 | 2 | 6 | 9 | 2 | 4 | 7 | ||||
| 4 | 3 | 3 | 3 | 3 | 6 | |||||||
| 5 | 0 | 2 | ||||||||||
| Day 7 | 1 | 0 | 8 | .012 | 0 | 0 | 5 | .098 | 0 | 0 | 5 | .002 |
| 2 | 7 | 5 | 1 | 7 | 10 | 1 | 2 | 10 | ||||
| 3 | 0 | 2 | 2 | 4 | 0 | |||||||
| 3 | 1 | 0 | ||||||||||
| Day 10 | 1 | 6 | 15 | .318 | 0 | 3 | 15 | .0006 | 0 | 1 | 13 | .002 |
| 4 | 1 | 0 | 1 | 4 | 0 | 1 | 6 | 2 | ||||
| Day 14 | 1 | 6 | 15 | .318 | 0 | 7 | 15 | – | 0 | 7 | 15 | – |
| 4 | 1 | 0 | ||||||||||
| Final | 1 | 7 | 15 | .99 | 0 | 7 | 15 | – | 0 | 7 | 15 | – |
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