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Pediatric Anesthesia 2009

19: 756–763

doi:10.1111/j.1460-9592.2009.03060.x

The use of NSAIDs in pediatric scoliosis surgery – a survey of physicians’ prescribing practice J A S O N H A YE S M D F R C P C * , C A R O L Y N E P E H O R A AND BRUNO BISSONNETTE MD†

RN*

*Department of Anesthesia and Pain Medicine, The Hospital for Sick Children, Toronto, Ontario, Canada and †Department of Anesthesia, University of Toronto, Toronto, Ontario, Canada

Summary Background: Pediatric scoliosis surgery is associated with considerable postoperative pain requiring opioids for analgesia. Nonsteroidal antiinflammatory drugs (NSAIDs) can be used as adjuvants for analgesia; however, the potential of these agents to affect bone healing raises concerns. No large-scale prospective studies have been performed to evaluate the benefit-to-risk ratio of NSAID use after pediatric scoliosis surgery. Given the lack of evidence in the literature, a survey of practice patterns of anesthesiologists from around the world was conducted with respect to the use of NSAIDs after pediatric spinal fusion surgery for scoliosis. Methods: One hundred and fourteen anesthesiologists from international academic pediatric hospitals were asked to complete an online survey. After 1 month, nonresponders were sent a second e-mail asking for their participation. All questions were developed specifically for this study. Results: Out of 80 anesthesiologists who responded 61 were included in the final analysis. Fifty-nine percent routinely use NSAIDs, the most common agents being intravenous ketorolac and oral ibuprofen. The majority of respondents begin to administer NSAIDs within the first three postoperative days for a duration of four or more days. The primary reason for not routinely prescribing NSAIDs was the risk of bone nonunion. Conclusions: This survey demonstrates that the practice patterns of pediatric anesthesiologists from around the world with respect to the administration of NSAIDs for the management of postoperative pain after pediatric spinal fusion reflects the conflicting evidence in the literature and the lack of high-quality studies in humans. Keywords: survey; nonsteroidal antiinflammatory drugs; spinal fusion; complications; side effects; children

Introduction Correspondence to: J. Hayes, The Hospital for Sick Children, 555 University Avenue, Toronto, Ontario M5G 1X8, Canada (email: jason.hayes@sickkids.ca).

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Pediatric scoliosis surgery is associated with considerable postoperative pain requiring parenteral opioids for analgesia. The use of opioids is associated

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with side effects such as respiratory depression, nausea, vomiting, urinary depression, and pruritus. Furthermore, the sedating effects associated with opioids may prevent patients from participating in physical therapy (1). Nonsteroidal antiinflammatory drugs (NSAIDs) are used to provide postoperative analgesia in pediatric patients. Numerous studies have shown that children undergoing orthopedic surgery who receive NSAIDs as an adjuvant to opioids had lower pain scores and fewer opioid side effects than those who did not (1–3). However, the potential of these agents to affect bone healing raises concerns. The inhibition of bone healing has been demonstrated in vitro (4), in animal research (5–14), and in human investigations (15,16). It has been suggested that the effect of NSAIDs on bone healing may be dependent on the duration of treatment and the dose administered (17,18). Studies have demonstrated that the administration of lower doses of ketorolac, a nonspecific NSAID, or cyclooygenase-2 inhibitors, such as celecoxib, does not affect the rate of bone nonunion (18). Many reviews have been written on this subject, with opinions expressed on both sides of the debate (17,19–21). Until well-designed prospective studies in humans are performed to clarify this issue, practitioners must decide how best to manage patients after corrective spinal surgery. Given the lack of clarity in the literature, a survey of practice patterns of anesthesiologists from around the world was conducted with respect to the use of NSAIDs after pediatric spinal fusion surgery for scoliosis. The emphasis of this survery was on reasons for and against the use of NSAIDs.

Methods With the approval by the Research Ethics Board at the Hospital for Sick Children, anesthesiologists from international academic pediatric hospitals were contacted by e-mail or phone by one of the authors (B. Bissonnette) during April and May 2008. Each contact was asked whether they would be willing to complete an online survey. If they agreed, an e-mail containing a link to the survey was sent. Each respondent was assigned a random identification number that they recorded during the survey in order to maintain confidentiality and to prevent the

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recording of more than one response from each participant. After 1 month, nonresponders were sent a second e-mail asking for their participation. A copy of the survey is included (Appendix 1). All questions were developed specifically for this study.

Results Demographics One hundred and fourteen anesthesiologists were contacted. Sixty-seven responded to the initial request and thirteen to the second request, for a total response rate of seventy percent. Of the 80 respondents, 61 completed the survey satisfactorily and were included in the analysis. (Figure 1) The remaining respondents were excluded for the folSurvey requests sent 114

Responses 80

Included in analysis 61

Use NSAIDs routinely 36 Intravenous Ketorolac Ketoprofen Parecoxib Diclofenac

12 10 2 2

Oral*

Excluded from analysis 19

Do not use NSAIDs routinely 25 Reasons** Nonunion Bleeding Gastric ulcer Kidney damage Infection

20 12 4 2 1

Ibuprofen 20 Diclofenac 9 Naproxen 3 Ketoprofen 2 Celecoxib 1 Mefenic acid 1

Figure 1 Flow diagram of survey responses. *Ten respondents use two or more oral agents. **Eleven respondents gave two or more reasons. NSAIDs, nonsteroidal antiinflammatory drugs.


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lowing reasons: (1) do not perform pediatric scoliosis correction cases (eight responses), (2) incomplete or no data entered (nine responses), and (3) contradictory information entered regarding the use of NSAIDs (two responses). The anesthesiologists were classified by country and whether or not NSAIDs are used (Table 1). The median number of surgeries performed at each institution per year for idiopathic and neuromuscular scoliosis by those who do use NSAIDs when compared to those who do not use NSAIDs were 30 (range 0–120) and 16 (range 1–60), respectively, and 45 (range 5–400) and 35 (range 5–200), respectively. Four respondents who do use NSAIDs did not enter data for the number of surgeries performed.

Geographic location North America Canada USA Mexico Europe England Ireland Scotland France Belgium Switzerland Germany Austria Norway Poland Italy Spain Finland Africa Algeria Morocco Tunisia South Africa Egypt Australasia China India Iran Saudi Arabia Singapore Australia New Zealand South America Brazil Unknown Total

Number of surveys sent

8 21 2 7 3 4 19 1 9 2 1 1 1 2 1 1 1 1 1 3 1 2 2 2 1 1 8 5

Use of NSAIDs Thirty-six respondents (59%) who perform scoliosis surgery replied that NSAIDs were routinely used in their center, compared to 25 (41%) who replied that NSAIDs were not routinely used. The majority (72%) of those who prescribe NSAIDs use an intravenous agent, usually ketorolac, followed by ketoprofen, parecoxib, and diclofenac. The most common dosing regimen for ketoroloc was 0.5 mgÆkg)1 every 6–8 h, with a 24-h maximum of 40–120 mg. A slightly greater percentage (75%) prescribes oral NSAIDs, ibuprofen being the most common agent; however, many indicated that they have a choice of two oral NSAIDs. Eighteen pre-

Number of respondents who perform scoliosis surgery and use NSAIDs postoperatively

Number of respondents who perform scoliosis surgery and does not use NSAIDs postoperatively

4 3

1 11

Table 1 Classification of respondents included in analysis according to routine use of NSAIDs and geographic location

1 1 1 7 1 2 1 1

2 2

1

1

1 1 1

1 1

2 2

2 3

3

2

114

36

3 1

1 25

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Figure 2 The percentage of respondents who initiate NSAID administration on each postoperative day. Postoperative day 0 = day of surgery. NSAID, nonsteroidal antiinflammatory drug.

Figure 3 The cumulative numbers of days NSAIDs are prescribed by percentage of respondents. Six days = day of surgery to postoperative day 5. NSAIDs, nonsteroidal antiinflammatory drugs.

scribe both intravenous and oral NSAIDs postoperatively, and nine prescribe only intravenous or oral NSAIDs. Thirty anesthesiologists responded to question five of the survey (Appendix 1) regarding the timing of NSAIDs administration. All of the respondents except one begin administering NSAIDs within the first three postoperative days, with the majority (60%) starting on the day of surgery (Figure 2). One respondent indicated that they would not prescribe NSAIDs until after the fifth postoperative day. Of the twenty-nine respondents who administer NSAIDs within the first six postoperative days (including the day of surgery), twelve (41%) prescribe NSAIDs for up to 3 days, and seventeen (59%) for 4 days or more (Figure 3). Six respondents administer NSAIDs beyond the fifth postoperative day.

the most common (8 ⁄ 13), followed by nonunion (5 ⁄ 13) and excessive bleeding (5 ⁄ 13). A respondent described one case of nonunion in a patient with neuromuscular scoliosis who developed an infected hematoma, and another commented that it was difficult to attribute excessive bleeding directly to the use of NSAIDs.

Reasons for not prescribing NSAIDs The most common reason for not routinely prescribing NSAIDs was the risk of bone nonunion, followed by risks of bleeding, gastric ulcer, kidney damage, and infection. One-quarter of respondents who do not prescribe NSAIDs replied that NSAIDs are unnecessary for adequate pain control.

Complications related to the use of NSAIDs Thirteen respondents described one or more complications related to their use. Gastric ulceration was

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Discussion Despite many concerns regarding the use of NSAIDs after pediatric scoliosis surgery, over one-half of anesthesiologists from around the world who responded to this survey prescribe NSAIDs for the management of postoperative pain. The majority use both intravenous and oral NSAIDs, and nonspecific agents are used much more often than COX-2specific agents. NSAIDs are usually started within the first 3 days after surgery and continued for 3 or more days. There did not appear to be a qualitative correlation between geographic location and the use of NSAIDs, except perhaps for the United States, where the majority of respondents (11 ⁄ 14) do not use NSAIDs. Another difference with respect to the demographics of NSAID use was the greater number of cases, particularly for neuromuscular scoliosis, performed in centers that do not use NSAIDs. The primary reason for not routinely prescribing NSAIDs was the risk of bone nonunion. The mechanisms by which NSAIDs inhibit bone healing may include decreased production of pro-


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staglandins, which are essential to maintain osteoblast activity (22), a direct cytotoxic effect on osteoblasts (4), and ⁄ or a negative effect on blood flow across a healing fracture(13). Numerous studies in animals have reported impaired osteogenesis after spinal fusion and an increased incidence of fractures after treatment with NSAIDs (5,6,23,24). Many of these animal studies used excessive doses (ketorolac 1–4 mgÆkg)1Æday)1 and celecoxib 3– 50 mgÆkg)1Æday)1), or for extended periods of time (up to 12 weeks). However, a recent study suggests that even short-term use of NSAIDs at clinically acceptable doses may be detrimental to fracture healing (24). Fortunately, the negative effects of NSAIDs on bone healing may be reversible after discontinuation (7). In adult humans, two retrospective studies of NSAID use after spinal fusion surgery found increased rates of bone nonfusion (15). However, the duration of treatment (>3 months) in one study and the dose of ketorolac (>2 mgÆkg)1Æday)1) in the other are considered excessive when compared to current pain management practices in humans. A subsequent retrospective study showed that the effects of NSAIDs on spinal fusion may be dose dependent (18). Ketorolac doses greater than 110 mgÆday)1 for 5 days after one or two level lumbar spinal fusion in adults resulted in a higher incidence of bone nonunion when compared to lower doses of ketorolac (£110 mgÆday)1), celecoxib (200–600 mgÆday)1), and rofecoxib (50 mgÆday)1) (18). A prospective study in a similar group of patients demonstrated that celecoxib 400 mg preoperatively followed by 400 mgÆday)1 for 5 days postoperatively did not increase the rate of nonunion at 1 year (25). Two studies have evaluated the use of ketorolac after posterior spinal fusion for scoliosis in adolescents (2,26). A small prospective study of 35 patients did not show an increase in the incidence of bone nonunion at 2 years in patients who received ketorolac 0.5 mgÆkg)1 (maximum 15 mg per dose) every 6 h for 36 h postoperatively compared to controls (2). However, only 14 patients (eight in the ketorolac group) were followed to the 2-year mark. A retrospective study of over 200 children found the same rate of reoperation (13%) for bone nonunion in the sixty patients who received ketorolac (0.5 mgÆkg)1 every 6 h intravenously for 2–3 days) and the control patients (26).

Excessive perioperative bleeding was the second most common reason cited for avoidance of NSAIDs. The two studies in children cited above did not detect an increase in volume of blood lost or rate of transfusion during or after the administration of ketorolac (2,26). However, neither study was designed specifically to detect a difference in bleeding. The use of COX-2-specific agents was low compared to nonspecific agents. The analgesic activity of NSAIDs is mediated primarily via the COX-2 isoforms, whereas the side effects are mediated through the COX-1 isoforms (27). The COX-2 agents may have less negative effects on bone healing when compared to nonspecific agents (4–6) and are associated with a lower incidence of NSAID-related side effects (28,29). In particular, the COX-2 inhibitors have no effect on platelets and do not increase perioperative bleeding (25). The COX-2 inhibitors may also play a role in the prevention of central sensitization of dorsal horn neurons, which can result in secondary hyperalgesia (29). It was somewhat surprising to us that COX-2 agents were used so infrequently given their many advantages when compared to nonspecific NSAIDs. However, we speculate that the higher cost of COX-2-specific agents, such as celecoxib, and also the recent withdrawal of rofecoxib and valdecoxib from the market by the manufacturers following the United States Food and Drug Administration warning against their use, may have contributed to this important observation. It was also interesting that many respondents did not think NSAIDs were beneficial for the management of pain after scoliosis surgery when numerous studies have demonstrated a significant reduction in opioid consumption and decrease in pain scores when ketorolac and COX-2-specific NSAIDs were used after orthopedic surgery, including spine procedures, in adults and children (2,3,24,25,30, 31). The use of NSAIDs in the immediate postoperative period may also reduce the incidence of chronic pain at the operative site (32). Although most investigations do not demonstrate a reduction in opioid-related side effects, we believe that any reasonable attempt to reduce morbidity associated with opioid consumption, particularly respiratory depression, should be considered. These investigations showed that NSAIDs are not without risk and almost 25% of respondents were directly

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aware of the potential complications related to their use. The weaknesses of the present study is similar to all other surveys reported (33). First, did the choice of sampling frame from around the world accurately represent the practices of anesthesiologists, as well as their institutions? Sampling was not carried out in a random fashion, but instead it was based on one of the author’s (B.B.) knowledge of individual anesthesiologists practicing at recognized academic centers internationally. This was performed in an attempt to obtain the best response rate possible from anesthesiologists who have experience with these types of cases. The response rate of 70% suggests that our approach was somewhat successful. Although the purpose was to obtain an international sample of responses, the majority of the respondents were from the United States and Western Europe. It is difficult to know the degree of nonresponse bias present in the present findings. However, all anesthesiologists contacted have a similar type of practice, and there does not appear to be a geographic bias to the nonresponders. Secondly, the validity and reliability of the questions in this survey were not determined a priori. Eleven of 79 respondents did not complete the survey properly, and a pilot study may have been helpful in this respect. Language may have played a role as the questions were available in English only. In summary, it is believed that the results of the present survey reflect the discrepancy in the literature regarding the use of NSAIDs after pediatric spinal fusion for scoliosis. Clearly, many believe that the benefits of NSAIDs for the management of postoperative pain outweigh the low, but potentially serious, risks of bone nonunion and excessive bleeding. Additional prospective studies to further define the risk-to-benefit ratio of NSAIDs, particularly with respect to nonunion, are needed. However, such investigations may be difficult to perform given the low incidence of adverse events, and thus large number of subjects are required.

References 1 Eberson CP, Pacicca DM, Ehrlich MG. The role of ketorolac in decreasing length of stay and narcotic complications in the postoperative pediatric orthopaedic patient. J Pediatr Orthop 1999; 19: 688–692.

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2 Munro HM, Walton SR, Malviya S et al. Low-dose ketorolac improves analgesia and reduces morphine requirements following posterior spinal fusion in adolescents. Can J Anaesth 2002; 49: 461–466. 3 Sutters KA, Shaw BA, Gerardi JA et al. Comparison of morphine patient-controlled analgesia with and without ketorolac for postoperative analgesia in pediatric orthopedic surgery. Am J Orthop 1999; 28: 351–358. 4 Chang JK, Wang GJ, Tsai ST et al. Nonsteroidal antiinflammatory drug effects on osteoblastic cell cycle, cytotoxicity, and cell death. Connect Tissue Res 2005; 46: 200– 210. 5 Brown KM, Saunders MM, Kirsch T et al. Effect of COX-2specific inhibition on fracture-healing in the rat femur. J Bone Joint Surg Am 2004; 86-A: 116–123. 6 Gerstenfeld LC, Thiede M, Seibert K et al. Differential inhibition of fracture healing by non-selective and cyclooxygenase-2 selective non-steroidal anti-inflammatory drugs. J Orthop Res 2003; 21: 670–675. 7 Gerstenfeld LC, Al-Ghawas M, Alkhiary YM et al. Selective and nonselective cyclooxygenase-2 inhibitors and experimental fracture-healing. Reversibility of effects after short-term treatment. J Bone Joint Surg Am 2007; 89: 114–125. 8 Ho ML, Chang JK, Wang GJ. Antiinflammatory drug effects on bone repair and remodeling in rabbits. Clin Orthop Relat Res 1995; 00: 270–278. 9 Long J, Lewis S, Kuklo T et al. The effect of cyclooxygenase-2 inhibitors on spinal fusion. J Bone Joint Surg Am 2002; 84-A: 1763–1768. 10 Martin GJ Jr, Boden SD, Titus L. Recombinant human bone morphogenetic protein-2 overcomes the inhibitory effect of ketorolac, a nonsteroidal anti-inflammatory drug (NSAID), on posterolateral lumbar intertransverse process spine fusion. Spine 1999; 24: 2188–2193. 11 Meunier A, Aspenberg P. Parecoxib impairs early metaphyseal bone healing in rats. Arch Orthop Trauma Surg 2006; 126: 433– 436. 12 Mullis BH, Copland ST, Weinhold PS et al. Effect of COX-2 inhibitors and non-steroidal anti-inflammatory drugs on a mouse fracture model. Injury 2006; 37: 827–837. 13 Murnaghan M, Li G, Marsh DR. Nonsteroidal anti-inflammatory drug-induced fracture nonunion: an inhibition of angiogenesis? J Bone Joint Surg Am 2006; 88(Suppl. 3): 140– 147. 14 Reikeraas O, Engebretsen L. Effects of ketorolac tromethamine and indomethacin on primary and secondary bone healing. An experimental study in rats. Arch Orthop Trauma Surg 1998; 118: 50–52. 15 Deguchi M, Rapoff AJ, Zdeblick TA. Posterolateral fusion for isthmic spondylolisthesis in adults: analysis of fusion rate and clinical results. J Spinal Disord 1998; 11: 459–464. 16 Glassman SD, Rose SM, Dimar JR et al. The effect of postoperative nonsteroidal anti-inflammatory drug administration on spinal fusion. Spine 1998; 23: 834–838. 17 Dumont AS, Verma S, Dumont RJ et al. Nonsteroidal antiinflammatory drugs and bone metabolism in spinal fusion surgery: a pharmacological quandary. J Pharmacol Toxicol Methods 2000; 43: 31–39. 18 Reuben SS, Ablett D, Kaye R. High dose nonsteroidal antiinflammatory drugs compromise spinal fusion. Can J Anaesth 2005; 52: 506–512. 19 Gajraj NM. The effect of cyclooxygenase-2 inhibitors on bone healing. Reg Anesth Pain Med 2003; 28: 456–465.


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20 Maxy RJ, Glassman SD. The effect of nonsteroidal antiinflammatory drugs on osteogenesis and spinal fusion. Reg Anesth Pain Med 2001; 26: 156–158. 21 Wedel DJ, Berry D. ‘‘He said, she said, NSAIDs’’. Reg Anesth Pain Med 2003; 28: 372–375. 22 Kawaguchi H, Pilbeam CC, Harrison JR et al. The role of prostaglandins in the regulation of bone metabolism. Clin Orthop Relat Res 1995; 00: 36–46. 23 Dimar JR, Ante WA, Zhang YP et al. The effects of nonsteroidal anti-inflammatory drugs on posterior spinal fusions in the rat. Spine 1996; 21: 1870–1876. 24 Simon AM, O’Connor JP. Dose and time-dependent effects of cyclooxygenase-2 inhibition on fracture-healing. J Bone Joint Surg Am 2007; 89: 500–511. 25 Reuben SS, Ekman EF. The effect of cyclooxygenase-2 inhibition on analgesia and spinal fusion. J Bone Joint Surg Am 2005; 87: 536–542. 26 Vitale MG, Choe JC, Hwang MW et al. Use of ketorolac tromethamine in children undergoing scoliosis surgery. An analysis of complications. Spine J 2003; 3: 55–62. 27 Hawkey CJ. COX-2 inhibitors. Lancet 1999; 353: 307–314. 28 Gilron I, Milne B, Hong M. Cyclooxygenase-2 inhibitors in postoperative pain management: current evidence and future directions. Anesthesiology 2003; 99: 1198–1208. 29 Sinatra R. Role of COX-2 inhibitors in the evolution of acute pain management. J Pain Symptom Manage 2002; 24: S18–S27. 30 Reuben SS, Connelly NR. Postoperative analgesic effects of celecoxib or rofecoxib after spinal fusion surgery. Anesth Analg 2000; 91: 1221–1225. 31 Vetter TR, Heiner EJ. Intravenous ketorolac as an adjuvant to pediatric patient-controlled analgesia with morphine. J Clin Anesth 1994; 6: 110–113. 32 Reuben SS, Ekman EF, Raghunathan K et al. The effect of cyclooxygenase-2 inhibition on acute and chronic donor-site pain after spinal-fusion surgery. Reg Anesth Pain Med 2006; 31: 6–13. 33 Burmeister LF. Principles of successful sample surveys. Anesthesiology 2003; 99: 1251–1252.

Accepted 5 May 2009

Appendix 1 1. Approximately how many pediatric spinal fusion cases for scoliosis correction are performed at your institution per year? Idiopathic scoliosis _______ Neuromuscular ⁄ secondary scoliosis _______ 2. Are nonsteroidal antiinflammatory drugs (NSAIDs) routinely (i.e usual practice for the majority of practitioners) administered for pain management in the immediate (first 5 days) postoperative period at your institution? Yes No 3a. Which intravenous NSAID(s) are routinely used (check all that apply)? None

Ketorolac Parecoxib Other nonspecific NSAIDs or COX-2 inhibitors (please specify) 3b. For each drug, please specify the dose (per kilogram body weight, e.g. mgÆkg)1) and frequency (e.g. every 8 h, t.i.d., q8h) of intravenous NSAID administration that is routinely used at your institution: 3c. If there is a limit on the maximum dose of intravenous NSAID that is routinely administered at your institution, please specify the absolute amount (e.g ketorolac 15 mg per dose or 60 mg per 24 h): No Yes (please specify limitations) 4a. Which oral NSAID(s) are routinely used (check all that apply)? None Ibuprofen ⁄ diclofenac ⁄ naproxen Celecoxib Other nonspecific NSAIDs or COX-2 inhibitors (please specify) 4b. For each drug, please specify the dose (per kilogram body weight, e.g. mgÆkg)1) and frequency (e.g. every 6 h, q.i.d., q6h) of oral NSAID administration that is routinely used at your institution: 4c. If there is a limit on the maximum dose of oral NSAID that is routinely administered at your institution, please specify the absolute amount (e.g ibuprofen 400 mg per dose or 1600 mg per 24 h): No Yes (please specify limitations) 5. On which postoperative days are NSAIDs routinely administered to patients after spinal fusion surgery (please check all that apply): Postoperative day 0 (day of surgery) Postoperative day 1 Postoperative day 2 Postoperative day 3 Postoperative day 4 Postoperative day 5 After postoperative day 5 (please provide details, if you wish) 6. If NSAIDs are NOT routinely administered, please estimate what percentage of patients, if any, are administered NSAIDs in the immediate postoperative period: Unknown Percentage (please enter) ______

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7. To the best of your knowledge, please specify why NSAIDs are NOT administered (check all that apply): Risk of nonunion (as determined by radiologic studies i.e. X-ray ⁄ CT or examination by surgeon) Risk of bleeding Risk of gastric ulceration Unnecessary for adequate postoperative pain control Other (please specify) 8. Are you aware of any patients who have experienced any of the following complications as a result

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of NSAID administration in the immediate postoperative period in the last 5 years? (check all that apply). Please do not supply any identifiable patient information. Nonunion of fusion (as determined by radiologic studies i.e. X-ray ⁄ CT or examination by surgeon) Excessive bleeding Kidney damage Gastric ulceration Other (please specify)



The use of NSAIDs in pediatric scoliosis surgery –a survey of physicians’ prescribing practice