-
Medicine Aug 2017This study aims to explore the effect of oxycodone hydrochloride injection on the immune function of patients who underwent radical resection of rectal cancer under... (Randomized Controlled Trial)
Randomized Controlled Trial
This study aims to explore the effect of oxycodone hydrochloride injection on the immune function of patients who underwent radical resection of rectal cancer under general anesthesia.Eighty patients were enrolled and randomly divided into group A and B (n = 40, each). All patients underwent general intravenous anesthesia. At the end of surgery, each patient in group A was injected with 5 mg (5 mL) of oxycodone hydrochloride, while 5 mg (5 mL) of morphine hydrochloride in group B. Venous blood was withdrawn in both groups at different time points. Changes in the numbers of T lymphocyte subsets and natural killer (NK) cells were determined by flow cytometry.First the numbers of T lymphocyte subsets and NK cells at T1, T2, T3, and T4 decreased in both groups, compared with those at T0, and the differences were statistically significant. Furthermore, the numbers reduced to a minimum at T2 and began to recover at T3. Second the differences between group A and B at T1, T2, T3, and T4 were statistically significant; and the numbers of T lymphocytes and NK cells were higher in group A than in group B at corresponding time points.Oxycodone hydrochloride and morphine hydrochloride both have inhibitory effects on immune function in patients undergoing radical resection of rectal cancer after surgery. However, oxycodone hydrochloride has a smaller effect compared to morphine hydrochloride.
Topics: Analgesics, Opioid; Anesthesia, General; Biomarkers; Female; Humans; Immunologic Factors; Male; Middle Aged; Morphine; Oxycodone; Rectal Neoplasms; Treatment Outcome
PubMed: 28767570
DOI: 10.1097/MD.0000000000007519 -
Journal of Pain and Symptom Management Oct 1991
Topics: Acetaminophen; Adult; Anus Neoplasms; Drug Combinations; Female; Humans; Oxycodone; Pain
PubMed: 1940492
DOI: 10.1016/0885-3924(91)90046-7 -
Journal of Opioid Management 2014To evaluate the long-term safety of oxycodone-hydrochloride and sequestered naltrexone-hydrochloride (ALO-02) administered for up to 12 months. (Clinical Trial)
Clinical Trial
A multicenter, 12-month, open-label, single-arm safety study of oxycodone-hydrochloride/naltrexone-hydrochloride extended-release capsules (ALO-02) in patients with moderate-to-severe chronic noncancer pain.
OBJECTIVE
To evaluate the long-term safety of oxycodone-hydrochloride and sequestered naltrexone-hydrochloride (ALO-02) administered for up to 12 months.
DESIGN
Open-label, single-arm safety study.
SETTING
Thirty-two US research centers (ClinicalTrials.gov identifier NCT01428583).
PATIENTS
Three hundred ninety-five adults (opioid experienced and opioid naïve) with moderate-to-severe chronic noncancer pain (CNCP).
INTERVENTIONS
Open-label, oral ALO-02 capsules, daily dose ranging from 20 to 160 mg oxycodone for up to 12 months.
MAIN OUTCOME MEASURES
Number and type of adverse events (AEs) and drugrelated AEs, including assessments of withdrawal (Clinical Opiate Withdrawal Scale; COWS), pharmacokinetics, efficacy, and aberrant behaviors (Current Opioid Misuse Measure).
RESULTS
A total of 193 (48.9 percent) patients received ALO-02 for ≥181 days and 105 (26.6 percent) patients for ≥361 days. The most common treatment-emergent AEs were nausea (25.3 percent), constipation (21.3 percent), vomiting (13.9 percent), and headache (11.6 percent). The most common drug-related AEs were constipation (18.0 percent), nausea (14.9 percent), somnolence (8.4 percent), fatigue (6.8 percent), dizziness (5.6 percent), and vomiting (5.1 percent). A majority of patients (86.6 percent) had a maximum COWS total score below the level for mild withdrawal symptoms at every visit throughout the study. Pain severity scores as measured by the short Form of the Brief Pain Inventory (BPI-SF) decreased over time.
CONCLUSIONS
Repeat dosing of ALO-02 for up to 12 months is safe and well tolerated in a CNCP population of both opioid-experienced and opioid-naïve patients. ALO-02 demonstrated a safety profile consistent with extended-release opioids and the expected analgesic efficacy. The addition of sequestered naltrexone had no significant clinical effect on patients when taken as directed.
Topics: Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Capsules; Chemistry, Pharmaceutical; Chronic Pain; Delayed-Action Preparations; Drug Administration Schedule; Drug Combinations; Drug Dosage Calculations; Drug Monitoring; Female; Humans; Male; Middle Aged; Naloxone; Narcotic Antagonists; Oxycodone; Pain Measurement; Severity of Illness Index; Time Factors; Treatment Outcome; United States
PubMed: 25531960
DOI: 10.5055/jom.2014.0239 -
Acta Anaesthesiologica Scandinavica May 2020Parenteral opioids are used for pain relief in labour but there are little data for oxycodone in this context. The aim of this study was to evaluate the efficacy, foetal...
BACKGROUND
Parenteral opioids are used for pain relief in labour but there are little data for oxycodone in this context. The aim of this study was to evaluate the efficacy, foetal exposure and safety of subcutaneous oxycodone in the latent phase of labour.
METHODS
This pragmatic trial included 76 parturients, who received subcutaneous oxycodone for pain relief in the latent phase of labour according to the hospital protocol: an initial dose 0.1 mg/kg, and a second dose, 0.05 mg/kg, could be administered four hours later. Pain intensity and pain relief were assessed using a numerical rating scale of 0-10. After delivery, blood samples from the maternal and umbilical veins were collected, and plasma concentrations of oxycodone and its main metabolites were quantified using UPLC-MS/MS. The Apgar scores and maternal and neonatal adverse effects were recorded.
RESULTS
The foetal exposure at birth was low, the median oxycodone and oxymorphone umbilical vein plasma concentrations were 1.2 ng/mL (range 0.21-7.8) and 0.14 ng/mL (0-0.26), respectively. Pain scores decreased substantially, from a median pain score of 7/10 before oxycodone to median scores of 5/10 at 30 minutes after administration, 5/10 at 60 minutes and 6/10 at 120 minutes. The median Apgar score was 9 (range 2-10) at 1 minute and 9 (6-10) at 5 minutes. Maternal adverse effects were mild, and there were no oxycodone-related neonatal adverse effects.
CONCLUSION
Subcutaneous oxycodone provided effective analgesia during the latent phase of labour. Newborn exposure at birth was low, and oxycodone was well-tolerated.
Topics: Adult; Analgesia, Obstetrical; Analgesics, Opioid; Female; Finland; Humans; Labor Pain; Labor, Obstetric; Oxycodone; Pain Management; Pregnancy; Young Adult
PubMed: 31950485
DOI: 10.1111/aas.13550 -
Drugs in R&D Sep 2017Oxycodone is a semisynthetic opioid used for the treatment of moderate to severe pain. Two separate studies were conducted to assess the pharmacokinetic bioequivalence... (Comparative Study)
Comparative Study Randomized Controlled Trial
Pharmacokinetic Bioequivalence Studies of an Extended-Release Oxycodone Hydrochloride Tablet in Healthy Japanese Subjects Under Fasting and Fed Conditions Without an Opioid Antagonist.
Oxycodone is a semisynthetic opioid used for the treatment of moderate to severe pain. Two separate studies were conducted to assess the pharmacokinetic bioequivalence of a newly formulated oxycodone hydrochloride extended-release tablet to a marketed oxycodone product in Japan under fasting and fed conditions. Each study was a randomized, open-label, single-dose, single-center, two-period, two-way crossover study. Healthy male Japanese subjects received the oxycodone 10-mg products under fasting and fed conditions. Blood samples were collected at specified time intervals, and plasma concentrations of oxycodone were analyzed using a validated liquid chromatography tandem mass spectrometry assay method. The pharmacokinetic parameters were determined via non-compartmental analysis. Pharmacokinetic metrics used for bioequivalence assessment were the maximum observed plasma concentration (C ) and the area under the concentration-time curve up to the last sampling time (AUC ). A total of 24 healthy subjects were enrolled in each study. One subject withdrew after completion of the first sequence under fed conditions. The ratios of geometric least square means for C and AUC under fasting conditions were 1.1110 (90% confidence interval [CI] 1.0562-1.1687) and 0.9946 (90% CI 0.9670-1.0231), respectively. The ratios of geometric least square means for C and AUC under fed conditions were 1.1417 (90% CI 1.0959-1.1895) and 1.0135 (90% CI 0.9810-1.0470), respectively. The 90% CIs were within the predefined range (0.80-1.25). Both treatments were well tolerated when taken without an opioid antagonist in healthy Japanese subjects. Pharmacokinetic bioequivalence between test and reference formulations under fasting and fed conditions was concluded in terms of both rate and extent of absorption.
Topics: Adult; Analgesics, Opioid; Area Under Curve; Chromatography, Liquid; Cross-Over Studies; Delayed-Action Preparations; Fasting; Food-Drug Interactions; Humans; Japan; Male; Oxycodone; Tablets; Tandem Mass Spectrometry; Therapeutic Equivalency; Young Adult
PubMed: 28516342
DOI: 10.1007/s40268-017-0184-x -
Journal of Infection and Chemotherapy :... Jul 2017Oxaliplatin is a platinum-based chemotherapeutic agent that holds a prominent position in the treatment of colorectal and gastric cancers. However, severe...
Oxaliplatin is a platinum-based chemotherapeutic agent that holds a prominent position in the treatment of colorectal and gastric cancers. However, severe oxaliplatin-related vascular pain can be problematic for patients. Here we describe seven patients who experienced severe vascular pain caused by oxaliplatin administration. All seven patients were treated with capecitabine and oxaliplatin or capecitabine plus oxaliplatin with bevacizumab as an adjuvant or a treatment for recurrent colorectal cancer, respectively. Patients experienced intolerable vascular pain during oxaliplatin administration, which continued for several days. Moreover, vascular pain also induced insomnia and appetite loss in all patients. We recommended implantation of a central venous (CV) port to the patients; however, all patients declined this treatment. In addition, various known countermeasures were taken, but were ineffective. Therefore, patients were orally administered oxycodone hydrochloride hydrate (Oxinorm) 45 min prior to oxaliplatin administration. This pretreatment successfully reduced vascular pain and improved subsequent chemotherapy. Oxinorm is a fast-acting opioid that can be an effective and practical option for severe vascular pain induced by oxaliplatin. The present report is the first description that emphasizes the usefulness of Oxinorm to overcome the vascular pain induced by administration of oxaliplatin via a peripheral vein.
Topics: Adult; Antineoplastic Agents; Colorectal Neoplasms; Female; Humans; Male; Middle Aged; Organoplatinum Compounds; Oxaliplatin; Oxycodone; Pain; Premedication
PubMed: 28285948
DOI: 10.1016/j.jiac.2017.02.006 -
BioMed Research International 2019Oxycodone is a widely used opioid analgesic, which is involved in cancer pain and non-cancer pain. This study is intended to understand the publication characteristics...
BACKGROUND
Oxycodone is a widely used opioid analgesic, which is involved in cancer pain and non-cancer pain. This study is intended to understand the publication characteristics of oxycodone research field and assess the quality of pertinent articles from 1998 to 2017.
METHODS
Oxycodone-related publications from 1998 to 2017 were retrieved from the Web of Science (WOS) and PubMed database. These papers were coded across several categories, such as total number, journals, countries, institutions, authors and citations reports. And the analysis of co-occurrence keywords was handled by VOSviewer software.
RESULTS
According to search strategies, a total of 2659 articles on oxycodone were published in world from 1998 to 2017 in WOS. Among the top 10 most productive organizations, six of them were American institutes, two of them were pharmaceutical enterprises and the other three were Finnish, Australian and Canadian institutes, which is similar with the distribution by country/region. Drewes AM from Denmark published most articles and PAIN MEDICINE is the most productive journal in oxycodone area. Meanwhile, clinical studies occupy a dominant position during the past 20 years. The 10 most cited papers were listed. Among these articles, 8 of them are reviews and 2 of those are meta-analysis. And the last decade (2008-2017) displayed that the newest keywords focus on "double-blind", "randomized controlled trial" and "neuropathic pain".
CONCLUSIONS
The findings provided a comprehensive overview of oxycodone research. In view of the adverse effects of oxycodone, high-quality oxycodone studies both in basic studies and clinical trials need to be completed.
Topics: Analgesics, Opioid; Bibliometrics; Cancer Pain; Humans; Neuralgia; Oxycodone; Publications
PubMed: 31781650
DOI: 10.1155/2019/9096201 -
Brain Research Nov 2017The Centers for Disease Control has declared opioid abuse to be an epidemic. Overdose deaths are largely assumed to be the result of excessive opioid consumption. In...
The Centers for Disease Control has declared opioid abuse to be an epidemic. Overdose deaths are largely assumed to be the result of excessive opioid consumption. In many of these cases, however, opioid abusers are often polydrug abusers. Benzodiazepines are one of the most commonly co-abused substances and pose a significant risk to opioid users. In 2016, the FDA required boxed warnings - the FDA's strongest warning - for prescription opioid analgesics and benzodiazepines about the serious risks associated with using these medications at the same time. The point of our studies was to evaluate the interactions between these two classes of drugs. We investigated whether diazepam adds to the depressant effects of opioids or do they alter the levels of tolerance to opioids. In the present study, we have found that the antinociceptive tolerance that developed to repeated administration of oxycodone was reversed by an acute dose of diazepam. Antinociceptive tolerance to hydrocodone was also reversed by acute injection of diazepam; however, a fourfold higher dose of diazepam was required when compared to reversal of oxycodone-induced tolerance. These doses of diazepam did not potentiate the acute antinociceptive effect of either opioid. The same dose of diazepam that reversed oxycodone antinociceptive tolerance also reversed oxycodone locomotor tolerance while having no potentiating effects. These studies show that diazepam does not potentiate the acute effect of prescription opioids but reverses the tolerance developed after chronic administration of the drugs.
Topics: Analgesics, Opioid; Animals; Diazepam; Dose-Response Relationship, Drug; Drug Tolerance; Hydrocodone; Male; Mice; Opioid-Related Disorders; Oxycodone
PubMed: 28830768
DOI: 10.1016/j.brainres.2017.08.017 -
British Journal of Clinical Pharmacology Apr 2017This study aimed to characterize the pharmacokinetics of oxycodone and its major metabolites in infants and covered the age range between extremely preterm neonates and... (Clinical Trial)
Clinical Trial
AIMS
This study aimed to characterize the pharmacokinetics of oxycodone and its major metabolites in infants and covered the age range between extremely preterm neonates and 2-year-old infants.
METHODS
Seventy-nine infants (gestational age 23-42 weeks; postnatal age 0-650 days) received intravenous oxycodone hydrochloride trihydrate at a dose of 0.1 mg kg during or after surgery. Three to seven blood samples were taken from each infant, and plasma concentrations of oxycodone, noroxycodone, oxymorphone, and noroxymorphone were quantified. The unconjugated forms of these compounds were determined in urine collected after up to 24 or 48 h from 25 infants. Pharmacokinetics was determined using noncompartmental analysis and reported for six clinically relevant age groups based on postmenstrual age.
RESULTS
Oxycodone pharmacokinetics changed markedly with patient age. Preterm neonates were found to have the highest pharmacokinetic variability out of the study population. In extremely preterm neonates (n = 6) median of elimination half-life was 8.8 h (range 6.8-12.5), in preterm (n = 11) 7.4 h (4.2-11.6), and in older neonates (n = 22) 4.1 h (2.4-5.8), all of which were significantly longer than that in infants aged 6-24 months (n = 12) 2.0 h (1.7-2.6). Median renal clearance was fairly constant in all age groups, whereas non-renal clearance markedly increased with age. Noroxycodone was the major metabolite in plasma and urine.
CONCLUSIONS
Oxycodone elimination is slower and pharmacokinetic variability more pronounced in neonates when compared to older infants. These findings highlight the importance of careful dose titration for neonates.
Topics: Age Factors; Analgesics, Opioid; Child, Preschool; Female; Half-Life; Humans; Infant; Infant, Extremely Premature; Infant, Newborn; Infant, Premature; Male; Morphinans; Oxycodone; Prospective Studies; Time Factors
PubMed: 27780305
DOI: 10.1111/bcp.13164 -
Journal of Pain & Palliative Care... 2003
Topics: Dose-Response Relationship, Drug; Humans; Narcotics; Oxycodone; Substance-Related Disorders
PubMed: 14640335
DOI: 10.1080/j354v17n01_01