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      Physical Compatibility and Chemical Stability of Fentanyl and Naloxone Hydrochloride in 0.9% Sodium Chloride Injection Solution for Patient-Controlled Analgesia Administration

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          Background and Objective

          The combination of naloxone hydrochloride (NH) and fentanyl citrate (FC) in patient-controlled analgesia (PCA) is examined to reduce the risk of opioid-induced nausea and vomiting. However, there are no such commercially available drug mixtures, and there is also no published evidence on the compatibility and stability of NH and FC. Thus, the primary purpose of the current research is to investigate the physical compatibility and chemical stability of NH when mixed with FC over a 72-h period in a 0.9% sodium chloride injection solution for PCA administration under storage at 4°C and 25°C.


          Test solutions of 20 μg/mL FC and 4 μg/mL NH were prepared and stored in polyvinyl chloride (PVC) bags or glass bottles with a 0.9% sodium chloride injection solution as the diluent. During the 72-h storage period at 4°C or 25°C without light protection, the concentrations of the test drugs were assayed via high-performance liquid chromatography (HPLC), and the physical compatibility was determined with the naked eye. Furthermore, pH measurement of each sample was also performed with a pH meter.


          The percentages of the initial concentrations of FC and NH in the various solutions were maintained at a minimum of 98% over the 72-h study period. All of the mixtures remained clear and colourless throughout the observation period, and no precipitation or turbidity was observed in any of the batches.


          The 20 μg/mL FC test solution was physically compatible and chemically stable with the 4 μg/mL NH test solution when stored at 4°C or 25°C in PVC bags or glass bottles containing the 0.9% sodium chloride injection solution.

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          Most cited references 30

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          Comparison of intravenous or epidural patient-controlled analgesia in the elderly after major abdominal surgery.

          Patient-controlled analgesia (PCA) with intravenous morphine and patient-controlled epidural analgesia (PCEA), using an opioid either alone or in combination with a local anesthetic, are two major advances in the management of pain after major surgery. However, these techniques have been evaluated poorly in elderly people. This prospective, randomized study compared the effectiveness on postoperative pain and safety of PCEA and PCA after major abdominal surgery in the elderly patient. Seventy patients older than 70 yr of age and undergoing major abdominal surgery were assigned randomly to receive either combined epidural analgesia and general anesthesia followed by postoperative PCEA, using a mixture of 0.125% bupivacaine and sufentanil (PCEA group), or general anesthesia followed by PCA with intravenous morphine (PCA group). Pain intensity was tested three times daily using a visual analog scale. Postoperative evaluation included mental status, cardiorespiratory and gastrointestinal functions, and patient satisfaction scores. Pain relief was better at rest (P = 0.001) and after coughing (P = 0.002) in the PCEA group during the 5 postoperative days. Satisfaction scores were better in the PCEA group. Although incidence of delirium was comparable in the PCA and PCEA groups (24% vs. 26%, respectively), mental status was improved on the fourth and fifth postoperative days in the PCEA group. The PCEA group recovered bowel function more quickly than did the PCA group. Cardiopulmonary complications were similar in the two groups. After major abdominal surgery in the elderly patient, patient-controlled analgesia, regardless of the route (epidural or parenteral), is effective. The epidural route using local anesthetics and an opioid provides better pain relief and improves mental status and bowel activity.
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            Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous femoral nerve sheath block on rehabilitation after unilateral total-hip arthroplasty.

            Regional analgesic techniques allow better postoperative rehabilitation and shorter hospital stay after major knee surgery. The authors tested the hypothesis that similar results could be obtained after total-hip arthroplasty. Forty-five patients scheduled for THA under general anesthesia were randomly divided into 3 groups. Postoperative analgesia was provided during the first 48 hours, with intravenous patient-controlled analgesia (IV PCA) induced by morphine (dose, 1.5 mg; lockout interval, 8 min) in group IV, continuous femoral nerve sheath block in group FNB, and continuous epidural analgesia in group EPI. The day after surgery, the 3 groups started identical physical therapy regimens. Pain scores at rest and on movement, supplemental analgesia, side effects, daily degree of maximal hip flexion and abduction, day of first walk, and duration of hospital stay were recorded. Population data, quality of pain relief, postoperative hip rehabilitation, and duration of hospital stay were comparable in the 3 groups. When compared with the two other techniques, continuous FNB was associated with a lower incidence of side effects (no nausea/vomiting, urinary retention, arterial hypotension, or catheter problem during the first 48 hours in 20%, 60%, and 13% of patients in groups IV, FNB, and EPI, respectively). This study suggests that IV PCA with morphine, continuous FNB, and continuous epidural analgesia provide similar pain relief and allow comparable hip rehabilitation and duration of hospital stay after total-hip arthroplasty (THA). As continuous FNB is associated with less side effects, it appears to offer the best option of the three.
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              Respiratory arrest in an obstetric patient using remifentanil patient-controlled analgesia.

              Remifentanil patient-controlled analgesia is well established in many centres and provides satisfactory pain relief for many women in labour. We describe a patient using remifentanil patient-controlled analgesia who suffered a respiratory arrest requiring a brief period of ventilation. In our institution, remifentanil patient-controlled analgesia has been offered to women in labour since 2009. Up to this point, we had not observed any critical incidents in over 130 patients using this mode of analgesia in our labour suite. Anaesthesia © 2012 The Association of Anaesthetists of Great Britain and Ireland.

                Author and article information

                Drug Des Devel Ther
                Drug Des Devel Ther
                Drug Design, Development and Therapy
                09 October 2020
                : 14
                : 4179-4187
                [1 ]Department of Pharmacy, Renmin Hospital of Wuhan University , Wuhan, Hubei 430060, People’s Republic of China
                [2 ]Department of Pharmacy, Dongfeng Hospital, Hubei University of Medicine , Shiyan, Hubei 442008, People’s Republic of China
                [3 ]Department of Endocrinology, Renmin Hospital of Wuhan University , Wuhan, Hubei 430060, People’s Republic of China
                Author notes
                Correspondence: Benhong ZhouDepartment of Pharmacy, Renmin Hospital of Wuhan University , Wuhan, Hubei430060, People’s Republic of ChinaTel +86 15335898431 Email benhongzh@whu.edu.cn

                These authors contributed equally to this work

                © 2020 Chen et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                Page count
                Figures: 5, Tables: 4, References: 30, Pages: 9
                Original Research


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