Steroids and A Double-blind
Rhinoplasty
Study
Dieter F. Hoffmann, MD; Ted A. Cook, MD; Vito C. Quatela, MD; Tom D. Peter J. Brownrigg, MD; Robert E. Brummett, PhD
\s=b\ Many facial plastic surgeons use \s=b\ operative steroids to reduce postoperative edema and morbidity. This use of steroids is based more on theory and anecdotal experience than on controlled studies. We studied 49 patients undergoing rhinoplasty in a randomized, double-blind fashion to evaluate the effects of perioperative and postoperative steroid use. We found significantly less postoperative eyelid and paranasal edema in those patients receiving steroids. In addition, trends toward less ecchymosis, less intranasal edema, and less discomfort in the patients receiving
steroids
were
noted.
(Arch Otolaryngol 1991;117:990-993)
Head
Neck
Accepted for publication March 13,
Surg.
1991. From the Division of Facial Plastic Surgery, Department of Otolaryngology\p=m-\Headand Neck Surgery, Oregon Health Sciences University, Portland (Drs Hoffmann, Cook, and Brummett); the Department of Otolaryngology, the University of Rochester (NY) Medical Center (Dr Quatela); the Department of Otolaryngology\p=m-\Headand Neck Surgery, the Mayo Graduate School of Medicine, Rochester, Minn (Dr Wang); and the Department of Otolaryngology\p=m-\Headand Neck Surgery, University of Ottawa (Ontario) (Dr Brownrigg). Read before the Fifth International Symposium of Facial Plastic and Reconstructive Surgery of the Head and Neck, Toronto, Ontario, June 26,1989. Reprint requests to Department of Otolaryngology\p=m-\Headand Neck Surgery, Oregon Health Sciences University, 3181 SW Sam Jackson Park Rd,
Portland, OR 97201 (Dr Cook).
Wang, MD;
reduce post¬ steroids Theoperativeofbased morbidity due edema theoretical and use
to
to
on is generally anecdotal considerations. Theoretical¬ ly, the anti-inflammatory properties of glucocorticoids result in diminished vascular permeability, leading to less exudation and diminished edema. Sub¬ jectively, many respected facial plastic surgeons are convinced that steroid use results in diminished postoperative morbidity. Nevertheless, few well-con¬ trolled studies have documented the efficacy of steroid use in facial plastic surgery. We designed a prospective,
randomized, double-blind study
to
evaluate the effect of perioperative and postoperative steroid use in rhinoplasty. Closely observed were postop¬ erative edema of the upper and lower
eyelids, paranasal edema, periorbital ecchymosis, intranasal edema, patient discomfort, and complications. MATERIALS AND METHODS
Forty-nine patients were studied who un¬ rhinoplasty that was either per¬ formed or supervised by one of us (T.A.C.). Patients were randomized into a study group and a control group. The study group consist¬ ed of 24 patients who received 10 mg of intra¬ venous dexamethasone intraoperatively, 50 mg of oral prednisone on the first postop¬ erative day, tapering by 10 mg/d until the derwent
Downloaded From: http://archotol.jamanetwork.com/ by a Monash University Library User on 06/18/2015
final dose of 10 mg on day 5. The control group of 25 patients received identical-ap¬ pearing placebo intraoperatively and postoperatively. The patient and physician were blinded until the completion of the study.
Appropriate approval was procured through the hospital investigational committee, and informed consent was obtained from all pa¬ tients. The patients were then seen on post¬ operative days 1, 4, and 7. Edema of the upper and lower eyelid and periorbital ecchymosis were evaluated using a graded scale from 0 to 4 + (Figs 1 and 2). Paranasal edema was graded from 0 to 4+ visually and by palpating the soft tissue of the cheek. Intranasal edema was evaluated by anterior rhinoscopic examination and graded from 0 to 4 + by determining the amount of septal and tur¬ binate edema and the patency of the airway. Each patient was graded independently by at least two observers at each visit. These ob¬ servers consisted of a resident (D.H.), a fa¬ cial .plastic fellow (V.Q., T.W., and P.B.), and a facial plastic surgeon (T.A.C.). Pa¬ tients were asked to grade their discomfort from 0 to 4+ and tabulate the number of ibuprofen tablets (400 mg) taken orally. Scores were then averaged for each visit to obtain a final score for each patient in each category on postoperative days 1, 4, and 7. Scores were consistently similar between ob¬ servers and were noted never to vary by more than one grade on the scale. At the completion of the study, the code was broken and an average was calculated for the study group patients and the control group patients for each parameter. The values were then
Results of Parameters Studied Average Score Parameter
Day
Lower
Value
Steroid Group
Placebo Group
0.85
1.61
.0027
0.42
.0729
0.85
1.33
.0285
1.39
1.83
.1517
1.54
1.18
.1522 .2407
Upper eyelid edema
eyelid edema
Periorbital
ecchymosis
Intranasal edema
Method to evaluate eyelid edema. 0 indi¬ cates none; 1 +, minimal; 2 + onto iris; 3 + covering iris; and 4 + massive, swollen shut.
Fig 1.
Paranasal edema
1.33
1.45
.2146
0.80
.7277
2.02
.0046
—
,
.0500 .8978
,
,
0.75
.3596
Patient discomfort 0.84 0.59
Analgesics used
0.64
.7470
8.0
.1390
2.5
3.5
Fig 2. Method to evaluate periorbital ecchymosis. 0 indicates none; 1 +, medial; 2 +, to pupil; 3 +, past pupil; 4 +, to lateral canthus. —
evaluated statistically using a one-way anal¬ ysis of variance with SPSS/PC + software values less (SPSS, Chicago, 111). than .05 were considered statistically signifi¬ cant in evaluating the difference between the two groups.
patients in the study group given any medications other than those
None of the were
used for local anesthesia and intravenous an¬ algesia. No antibiotics were given perioperatively but were used postoperatively in five patients who demonstrated clinical evidence of a local infectious process (see the "Results" section).
RESULTS
Forty-nine patients were studied who were undergoing rhinoplasty with osteotomies. Twenty-four patients re¬ ceived the study drug, and 25 patients received the placebo. The age range was 15 to 70 years. Thirty-six proce¬ dures were performed by one of the authors (T.A.C.) and 13 by the resi¬ dent (D.H.). Twenty patients under¬ went external rhinoplasty, and 29 pa¬ tients underwent a closed procedure. The distribution of patients receiving the study drug was not significantly different between the senior surgeon and the resident surgeon. Similarly,
patients undergoing closed-vs-open rhinoplasty were almost equally dis¬ tributed between the study and control groups. No attempt was made, howev¬
er, to control distribution in either
surgeon or the surgical approach. The results of the parameters stud¬ ied are summarized in the Table. The measurement of edema in the upper and lower eyelids at postoperative days 1 and 4 was significantly dimin¬ ished in the group receiving steroids (Figs 3 and 4). At day 7, the edema in the upper eyelid was still diminished, however not to a statistically signifi¬ cant degree. The edema in the lower
eyelid had nearly equalized. Although an early trend toward diminished post¬ operative ecchymosis in the study
was noted, this was not statisti¬ cally significant (Fig 5). The amount of paranasal edema at days 1 and 4 was
group
also significantly lower in the steroid group (Fig 6). As was the case with the edema in the lower eyelid, this had equalized by day 7. Intranasal edema tended to be lower in the study group. This was, however, not statistically different (Fig 7). In addition, patient discomfort tended to be diminished in the study group; however, this was statistically significant on day 4 only (Fig 8). Also, a trend toward lower
requirements for analgesics in the group receiving steroids was observed (Fig 9). Five patients experienced a postop¬ erative wound infection manifested by erythema and tenderness. Four of these patients had undergone an au¬ togenous or irradiated cartilage im¬ plant. Only one patient was in the steroid group. One patient who re¬ ceived steroids experienced gastroin¬ testinal bleeding due to gastritis. He originally had not admitted to a history of alcohol abuse and peptic ulcer disease.
COMMENT
operative use of steroids, partic¬ ularly in facial plastic surgery, suffers The
lack of well-controlled studies. a steroid nasal spray after rhinoplasty, reportedly ob¬ taining a good-to-excellent airway in most patients. Kittel and Masing2 in¬
from
a
Wing1 reported using
jected 6-methyl-21 acetyl-prednisolone
into the "soft parts of the cheek" in 796 patients who underwent a rhinoplasty. They noted a reduction in edema and periorbital ecchymosis when compared with 27 patients receiving the same medication subgluteally. No control groups were utilized in either of the preceding studies. Habal and Powell'
Downloaded From: http://archotol.jamanetwork.com/ by a Monash University Library User on 06/18/2015
Days
Days
Fig 3. —Upper eyelid edema scores. Open squares indicate steroid; closed circles, placebo; and asterisks, P
Rhinoplasty
Study
Dieter F. Hoffmann, MD; Ted A. Cook, MD; Vito C. Quatela, MD; Tom D. Peter J. Brownrigg, MD; Robert E. Brummett, PhD
\s=b\ Many facial plastic surgeons use \s=b\ operative steroids to reduce postoperative edema and morbidity. This use of steroids is based more on theory and anecdotal experience than on controlled studies. We studied 49 patients undergoing rhinoplasty in a randomized, double-blind fashion to evaluate the effects of perioperative and postoperative steroid use. We found significantly less postoperative eyelid and paranasal edema in those patients receiving steroids. In addition, trends toward less ecchymosis, less intranasal edema, and less discomfort in the patients receiving
steroids
were
noted.
(Arch Otolaryngol 1991;117:990-993)
Head
Neck
Accepted for publication March 13,
Surg.
1991. From the Division of Facial Plastic Surgery, Department of Otolaryngology\p=m-\Headand Neck Surgery, Oregon Health Sciences University, Portland (Drs Hoffmann, Cook, and Brummett); the Department of Otolaryngology, the University of Rochester (NY) Medical Center (Dr Quatela); the Department of Otolaryngology\p=m-\Headand Neck Surgery, the Mayo Graduate School of Medicine, Rochester, Minn (Dr Wang); and the Department of Otolaryngology\p=m-\Headand Neck Surgery, University of Ottawa (Ontario) (Dr Brownrigg). Read before the Fifth International Symposium of Facial Plastic and Reconstructive Surgery of the Head and Neck, Toronto, Ontario, June 26,1989. Reprint requests to Department of Otolaryngology\p=m-\Headand Neck Surgery, Oregon Health Sciences University, 3181 SW Sam Jackson Park Rd,
Portland, OR 97201 (Dr Cook).
Wang, MD;
reduce post¬ steroids Theoperativeofbased morbidity due edema theoretical and use
to
to
on is generally anecdotal considerations. Theoretical¬ ly, the anti-inflammatory properties of glucocorticoids result in diminished vascular permeability, leading to less exudation and diminished edema. Sub¬ jectively, many respected facial plastic surgeons are convinced that steroid use results in diminished postoperative morbidity. Nevertheless, few well-con¬ trolled studies have documented the efficacy of steroid use in facial plastic surgery. We designed a prospective,
randomized, double-blind study
to
evaluate the effect of perioperative and postoperative steroid use in rhinoplasty. Closely observed were postop¬ erative edema of the upper and lower
eyelids, paranasal edema, periorbital ecchymosis, intranasal edema, patient discomfort, and complications. MATERIALS AND METHODS
Forty-nine patients were studied who un¬ rhinoplasty that was either per¬ formed or supervised by one of us (T.A.C.). Patients were randomized into a study group and a control group. The study group consist¬ ed of 24 patients who received 10 mg of intra¬ venous dexamethasone intraoperatively, 50 mg of oral prednisone on the first postop¬ erative day, tapering by 10 mg/d until the derwent
Downloaded From: http://archotol.jamanetwork.com/ by a Monash University Library User on 06/18/2015
final dose of 10 mg on day 5. The control group of 25 patients received identical-ap¬ pearing placebo intraoperatively and postoperatively. The patient and physician were blinded until the completion of the study.
Appropriate approval was procured through the hospital investigational committee, and informed consent was obtained from all pa¬ tients. The patients were then seen on post¬ operative days 1, 4, and 7. Edema of the upper and lower eyelid and periorbital ecchymosis were evaluated using a graded scale from 0 to 4 + (Figs 1 and 2). Paranasal edema was graded from 0 to 4+ visually and by palpating the soft tissue of the cheek. Intranasal edema was evaluated by anterior rhinoscopic examination and graded from 0 to 4 + by determining the amount of septal and tur¬ binate edema and the patency of the airway. Each patient was graded independently by at least two observers at each visit. These ob¬ servers consisted of a resident (D.H.), a fa¬ cial .plastic fellow (V.Q., T.W., and P.B.), and a facial plastic surgeon (T.A.C.). Pa¬ tients were asked to grade their discomfort from 0 to 4+ and tabulate the number of ibuprofen tablets (400 mg) taken orally. Scores were then averaged for each visit to obtain a final score for each patient in each category on postoperative days 1, 4, and 7. Scores were consistently similar between ob¬ servers and were noted never to vary by more than one grade on the scale. At the completion of the study, the code was broken and an average was calculated for the study group patients and the control group patients for each parameter. The values were then
Results of Parameters Studied Average Score Parameter
Day
Lower
Value
Steroid Group
Placebo Group
0.85
1.61
.0027
0.42
.0729
0.85
1.33
.0285
1.39
1.83
.1517
1.54
1.18
.1522 .2407
Upper eyelid edema
eyelid edema
Periorbital
ecchymosis
Intranasal edema
Method to evaluate eyelid edema. 0 indi¬ cates none; 1 +, minimal; 2 + onto iris; 3 + covering iris; and 4 + massive, swollen shut.
Fig 1.
Paranasal edema
1.33
1.45
.2146
0.80
.7277
2.02
.0046
—
,
.0500 .8978
,
,
0.75
.3596
Patient discomfort 0.84 0.59
Analgesics used
0.64
.7470
8.0
.1390
2.5
3.5
Fig 2. Method to evaluate periorbital ecchymosis. 0 indicates none; 1 +, medial; 2 +, to pupil; 3 +, past pupil; 4 +, to lateral canthus. —
evaluated statistically using a one-way anal¬ ysis of variance with SPSS/PC + software values less (SPSS, Chicago, 111). than .05 were considered statistically signifi¬ cant in evaluating the difference between the two groups.
patients in the study group given any medications other than those
None of the were
used for local anesthesia and intravenous an¬ algesia. No antibiotics were given perioperatively but were used postoperatively in five patients who demonstrated clinical evidence of a local infectious process (see the "Results" section).
RESULTS
Forty-nine patients were studied who were undergoing rhinoplasty with osteotomies. Twenty-four patients re¬ ceived the study drug, and 25 patients received the placebo. The age range was 15 to 70 years. Thirty-six proce¬ dures were performed by one of the authors (T.A.C.) and 13 by the resi¬ dent (D.H.). Twenty patients under¬ went external rhinoplasty, and 29 pa¬ tients underwent a closed procedure. The distribution of patients receiving the study drug was not significantly different between the senior surgeon and the resident surgeon. Similarly,
patients undergoing closed-vs-open rhinoplasty were almost equally dis¬ tributed between the study and control groups. No attempt was made, howev¬
er, to control distribution in either
surgeon or the surgical approach. The results of the parameters stud¬ ied are summarized in the Table. The measurement of edema in the upper and lower eyelids at postoperative days 1 and 4 was significantly dimin¬ ished in the group receiving steroids (Figs 3 and 4). At day 7, the edema in the upper eyelid was still diminished, however not to a statistically signifi¬ cant degree. The edema in the lower
eyelid had nearly equalized. Although an early trend toward diminished post¬ operative ecchymosis in the study
was noted, this was not statisti¬ cally significant (Fig 5). The amount of paranasal edema at days 1 and 4 was
group
also significantly lower in the steroid group (Fig 6). As was the case with the edema in the lower eyelid, this had equalized by day 7. Intranasal edema tended to be lower in the study group. This was, however, not statistically different (Fig 7). In addition, patient discomfort tended to be diminished in the study group; however, this was statistically significant on day 4 only (Fig 8). Also, a trend toward lower
requirements for analgesics in the group receiving steroids was observed (Fig 9). Five patients experienced a postop¬ erative wound infection manifested by erythema and tenderness. Four of these patients had undergone an au¬ togenous or irradiated cartilage im¬ plant. Only one patient was in the steroid group. One patient who re¬ ceived steroids experienced gastroin¬ testinal bleeding due to gastritis. He originally had not admitted to a history of alcohol abuse and peptic ulcer disease.
COMMENT
operative use of steroids, partic¬ ularly in facial plastic surgery, suffers The
lack of well-controlled studies. a steroid nasal spray after rhinoplasty, reportedly ob¬ taining a good-to-excellent airway in most patients. Kittel and Masing2 in¬
from
a
Wing1 reported using
jected 6-methyl-21 acetyl-prednisolone
into the "soft parts of the cheek" in 796 patients who underwent a rhinoplasty. They noted a reduction in edema and periorbital ecchymosis when compared with 27 patients receiving the same medication subgluteally. No control groups were utilized in either of the preceding studies. Habal and Powell'
Downloaded From: http://archotol.jamanetwork.com/ by a Monash University Library User on 06/18/2015
Days
Days
Fig 3. —Upper eyelid edema scores. Open squares indicate steroid; closed circles, placebo; and asterisks, P
