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문제 정의
- Therefore, we evaluated the combined use of fentanyl PCA and fentanyl TTS after orthopedic surgery. The aim of this study was to assess the ADR rates and spontaneous reporting rates in patients receiving fentanyl PCA alone or combined with fentanyl TTS and to analyse the relative risk (RR) and factors contributing to ADR risk when patients receiving fentanyl PCA were administered fentanyl TTS.
- The degree of pain differs according to the type of surgery, and it could affect the dose of the analgesic. Thus, we investigated the contributing factors through adjusted analysis. Surgeries were categorized into pelvis; spine; total knee replacement (TKR) surgery; and general surgery, and analyses according to different surgeries were conducted.
제안 방법
- The study was performed in three steps. First, of the reported ADRs, ADRs related to opioid analgesics were selected and the spontaneously reported ADRs with fentanyl PCA after orthopedic surgery were analysed. The RR and the contributing factors to ADR incidence when fentanyl TTS was added to fentanyl PCA were evaluated from spontaneous ADR reports.
- The RR and the contributing factors to ADR incidence when fentanyl TTS was added to fentanyl PCA were evaluated from spontaneous ADR reports. Second, a retrospective cohort study was performed by analysing all the cases wherein patients were prescribed fentanyl PCA, which consist of PCA alone or in combination with TTS, and assessing the ADR reporting rates in both groups. Third, in order to assess the actual ADR incidence, which includes those not reported spontaneously, we retrospectively reviewed the medical records of patients administered fentanyl TTS.
- Thus, we investigated the contributing factors through adjusted analysis. Surgeries were categorized into pelvis; spine; total knee replacement (TKR) surgery; and general surgery, and analyses according to different surgeries were conducted. The correlation between adverse effect and spine, pelvis, and TKR surgery is described in Table 3.
- First, of the reported ADRs, ADRs related to opioid analgesics were selected and the spontaneously reported ADRs with fentanyl PCA after orthopedic surgery were analysed. The RR and the contributing factors to ADR incidence when fentanyl TTS was added to fentanyl PCA were evaluated from spontaneous ADR reports. Second, a retrospective cohort study was performed by analysing all the cases wherein patients were prescribed fentanyl PCA, which consist of PCA alone or in combination with TTS, and assessing the ADR reporting rates in both groups.
- Fentanyl TTS is used for chronic pain relief when continuous administration of opioid analgesic is needed, and it is not recommended for acute pain relief or post-operative pain relief since it is difficult to control the dose according to the degree of pain. Therefore, we evaluated the combined use of fentanyl PCA and fentanyl TTS after orthopedic surgery. The aim of this study was to assess the ADR rates and spontaneous reporting rates in patients receiving fentanyl PCA alone or combined with fentanyl TTS and to analyse the relative risk (RR) and factors contributing to ADR risk when patients receiving fentanyl PCA were administered fentanyl TTS.
- Second, a retrospective cohort study was performed by analysing all the cases wherein patients were prescribed fentanyl PCA, which consist of PCA alone or in combination with TTS, and assessing the ADR reporting rates in both groups. Third, in order to assess the actual ADR incidence, which includes those not reported spontaneously, we retrospectively reviewed the medical records of patients administered fentanyl TTS. Two clinical pharmacy specialists independently evaluated the relevant patients’ medical records, and differences in opinions were resolved by an expert ADR consultant.
- At Chung-Ang University Hospital, fentanyl dose in fentanyl PCA differs according to the type of orthopaedic surgery. To eliminate any discrepancy in analysing this contributing factor, we categorized patients as those with general surgery(the other surgeries) and patients with pelvis, spine, and total knee replacement (TKR) surgery and then performed sub-analysis. We obtained patient’s medication history, age, gender, body mass index (BMI), fentanyl PCA dose, the status of kidney and liver function, fentanyl TTS dose, visual analogue scale (VAS), smoking status, surgical method, duration of surgery, and any ADR reports after PCA administration.
- We assessed the degree of post-orthopedic operative pain management by fentanyl PCA only and in combination with fentanyl TTS and the ADR incidence rate by retrospectively reviewing the spontaneous ADR reports and patients’ medical records.
- We assessed the inappropriate use of fentanyl TTS in combination with fentanyl PCA, which is used to manage acute post-operative pain, by reviewing spontaneous ADRs reported to an RPVC in patients receiving fentanyl PCA monotherapy and those receiving fentanyl TTS in combination. The ADR reporting rate in regards to fentanyl PCA was 2-fold higher in women than in men and was also higher in the smoking group, which is in line with the results of other studies.
대상 데이터
- Patients who were prescribed fentanyl PCA after orthopedic surgery from June 2012 to May 2013 at Chung-Ang University Hospital were evaluated. Chung-Ang University Hospital is a tertiary teaching hospital located in Seoul with 900 beds.
- 8% of the ADRs related to narcotics in the one-year time period). The 137 ADRs for fentanyl PCA included nausea and vomiting (117, 85.4%), dizziness (13, 9.5%), vertigo (5, 3.6%), chest tightness (1, 0.7%), and sweating (1, 0.7%). General characteristics of ADRs reported by patients are described in Table 1.
데이터처리
- In order to compare the difference in ADR incidence between the fentanyl PCA group and fentanyl TTS combination group, chi-square tests and Fisher’s exact test were used for nominal scale data, Mann-Whitney U test was used for ranking scale data, and Student’s t-test was used for continuous scale data.
성능/효과
- Among the reported opioid analgesics, the ADR reporting rates of fentanyl PCA were significantly high with 86 reports (54%); of the 86 reports, combined fentanyl PCA and fentanyl transdermal therapeutic system (fentanyl TTS: Durogesic DTrans®) accounted for 43 (50%) of ADR-reported cases.
- Assessment of the ADR risk ratio based on the actual spontaneous ADR reports showed that the ADR risk ratio was 3.04 (95% CI: 2.4–4.00, p<0.0001) and that it is 3-fold higher in the TTS combination group than in fentanyl PCA monotherapy group.
- 1). Since the ADR incidence rate was 35.3% in the TTS combination group after orthopedic surgery and the spontaneous ADR reporting rate was 22%, the actual ADR incidence and spontaneous ADR reporting rate ratio were approximately 60%.
- 2%), respectively. The ADR incidence rate according to spontaneous ADR reports in the PCA monotherapy group and TTS combination group was 6% and 22%, respectively (Fig. 1). Based on the spontaneous ADR reports, the RR for ADR in the TTS combination group was 3.
- The ADR incidence rate according to fentanyl TTS dose was investigated. The ADR incidence rate in patients receiving 12 and 25 mcg/h fentanyl TTS was 4 (18.1%) and 78 (37.1%), respectively. The prescription rate of high-dose fentanyl TTS among ADR reporting patients was high, but it was not significantly different (p=0.
- To investigate the contributing factors to ADR in the TTS combination group, we compared gender, smoking status, visual analogue scale (VAS) score, body mass index (BMI), age, fentanyl PCA dose, fentanyl TTS dose, duration of surgery in patients with ADR reported (82, 35.3%), and number of patients with no ADR reported (Table 2). No other contributing factors other than VAS (p=0.
후속연구
- Adding fentanyl TTS to fentanyl PCA increased the ADR incidence risk by 3-fold. Regular analysis of spontaneous ADRs, as shown in this study, would help in the surveillance of safe use of medications and help raise awareness to increase spontaneous ADR reporting.
- We assessed the degree of post-orthopedic operative pain management by fentanyl PCA only and in combination with fentanyl TTS and the ADR incidence rate by retrospectively reviewing the spontaneous ADR reports and patients’ medical records. We did not assess the use of other analgesics, such as NSAIDs, and only focused on fentanyl PCA and fentanyl TTS; therefore, a further study that includes the assessment of non-narcotic analgesics needs to be conducted. However, we confirmed that use of fentanyl TTS is a contributing factor to ADR incidence risk after assessing the appropriateness of fentanyl TTS use in combination with fentanyl PCA for post-operative pain management.
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