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PubMed1981

Problems with the use of oxycodone compound in patients with chronic pain.

In a pain management program (200 patients), a group of daily users of oxycodone compound (29 patients) and a subgroup who were taking a "high dose" of oxycodone compound (13 patients) were compared with a group of 171 non-users of oxycodone compound. A significantly lower treatment success rate was observed in the users (P = 0.04) and high-dose users (P = 0.03). A similar trend was seen in preliminary data available in a larger sample (514 patients). Continued study of these findings is necessary. Meanwhile, in patients with chronic pain, there should be cautious use of this compound.

Aspirin↗

PubMed1997

Comparison of respiratory effects of tramadol and oxycodone.

STUDY OBJECTIVE: To compare the respiratory effects of tramadol and oxycodone. DESIGN: Placebo-controlled, double-blind randomized study. SETTING: IV Department of Surgery, Helsinki University Central Hospital. PATIENTS: 36 ASA physical status I and II patients undergoing minor surgery with general anesthesia. INTERVENTIONS: The respiratory effects of intravenous (i.v.) tramadol 0.6 mg/kg and oxycodone 0.04 mg/kg were compared after induction of anesthesia with propofol and succinylcholine-facilitated endotracheal intubation. Patients spontaneously breathed halothane in 70% nitrous oxide and oxygen via a nonrebreathing valve. The trial drugs or placebo were given after recovery from neuromuscular block. MEASUREMENTS AND MAIN RESULTS: Inspiratory and expiratory oxygen and end-tidal carbon dioxide concentrations (ETCO2), tidal volume (VT) minute volume of ventilation (VE), and respiratory rate (RR) were recorded by side-stream spirometry with end-tidal halothane of 0.3% for 30 minutes before surgery. Oxycodone caused a significant respiratory depression seen as an increase in the inspiratory-expiratory oxygen difference and ETCO2 and as a decrease in VE and RR. On the contrary, the effect of tramadol were similar to those of placebo. VT was not affected by any study drug. CONCLUSION: Tramadol was not associated with respiratory depression in the present setting.

Adult↗

PubMedDate not supplied

The safety and efficacy of intrabursal oxycodone and bupivacaine in analgesia after shoulder surgery.

BACKGROUND AND OBJECTIVES: Peripherally administered opioids, e.g., intra-articular morphine, exert their analgesic action on local opioid receptors. The present study investigated the safety and efficacy of intrabursal oxycodone and bupivacaine in comparison with bupivacaine infiltration and interscalene brachial plexus block in conjunction with shoulder surgery. METHODS: A prospective, randomized study was conducted in 45 patients (15 per group) undergoing elective shoulder surgery during general anesthesia. At the end of the surgery, patients received either 10 mL 0.5% bupivacaine (group B) or 5 mg oxycodone and 10 mL 0.5% bupivacaine (group OB) in the subacromial bursa; interscalene plexus blocks were performed preoperative (group IPB). Postoperative analgesia was provided by patient-controlled analgesia, and the amount of intravenous fentanyl used during the total perioperative period was recorded. Postoperative pain was assessed by a visual analog scale. RESULTS: The total fentanyl consumption was lower in groups OB and IPB than in group B, and the difference reached statistical significance for both groups (P = .045 and P = .006, respectively). However, the groups OB and IPB did not differ in respect to their fentanyl requirements (P = 1.000). Visual analog scores for pain were lowest in group IBP during the first 6 postoperative hours. The incidence of adverse effects was similar in all groups; serious adverse effects did not occur. CONCLUSIONS: According to the present study, intrabursal oxycodone and bupivacaine offer an acceptable and efficient method for postoperative analgesia after shoulder surgery.

Adult↗

PubMed1999

Time course of changes in breathing pattern in morphine- and oxycodone-induced respiratory depression.

The time course of changes in breathing pattern in opioid-induced respiratory depression was characterised for two opioids. Intravenous morphine (0.039 mg.kg-1 bolus + 0.215 mg.kg-1.h-1 infusion) and oxycodone (0.05 mg.kg-1 bolus + 0.275 mg.kg-1.h-1 infusion) were administered to six healthy male volunteers for 2 h in a random, double-blind and cross-over fashion. Monitoring included pulse oximetry and noninvasive respiratory-inductive plethysmography for the measurement of breathing pattern. The total amounts of drugs given were 35.1 (0.0) mg [mean (SD)] morphine and 41.3 (8.0) mg oxycodone. Four of the six oxycodone infusions had to be stopped at 99 (14) min because of respiratory depression as judged by pulse oximetry. No morphine infusions were stopped. The first changes in breathing pattern were a decrease in respiratory rate and an increase in the contribution of the rib cage to tidal volume, while the compensatory increase in tidal volume became evident later. A decrease in minute ventilation and inspiratory duty cycle were also found.

Adult↗

PubMed2006

Oral oxycodone hydrochloride versus epidural anaesthesia for pain control after radical retropubic prostatectomy.

OBJECTIVE: To evaluate whether combined oral intake of paracetamol (4 x 1 g) + oxycodone hydrochloride (2x10 mg) is adequate and equivalent to epidural anaesthesia (EDA) with respect to postoperative pain control and postoperative mobilization after radical retropubic prostatectomy (RRP). MATERIAL AND METHODS: Forty consecutive patients scheduled for RRP were randomized to either: EDA with ropivacaine + paracetamol (4 x 1 g tablet) + injected or oral morphine on demand (EDA group); or infiltration of 25-40 ml of 0.25% bupivacaine into the wound + oxycodone hydrochloride (2 x 10 mg tablet) + paracetamol (4x1 g tablet) + injected or oral morphine on demand (OXY group). The groups were compared with respect to pain control determined by means of a visual analogue scale (VAS), time to free mobilization, hospital stay, complications, operation time and bleeding. RESULTS: Both analgesic regimens provided satisfactory analgesia, i.e. VAS scores remained significantly below 4 (p<0.0001). The EDA group experienced slightly less pain than the OXY group on the operation day but this was not significant: median VAS scores of 0.7 and 1.8, respectively (p=0.27). Median VAS scores during hospital stay were 1.7 in both treatment groups. VAS scores ranged from 0.1 to 3.3 and from 0.2 to 3.5 in the EDA and OXY groups, respectively. There was no significant difference in postoperative mobilization between the groups (p=0.06). The median duration of hospital stay was 3 nights in both groups. CONCLUSION: Postoperative pain control after RRP with oral oxycodone hydrochloride, paracetamol and extra morphine on demand is preferable to EDA when pain control as well as mobilization and costs are taken into account.

Acetaminophen↗

PubMedDate not supplied

Oxycodone involvement in drug abuse deaths. II. Evidence for toxic multiple drug-drug interactions.

Recent surveys suggest that the abuse of drugs, often in combination, is pervasive throughout society. Adverse consequences of drug abuse tend to be attributed to the single drug "most likely" to be responsible. This is frequently seen in fatality cases, particularly those involving opioids. However, it is difficult to determine the specific cause of death when multiple drugs are involved. Although enhanced toxicity of alcohol and other centrally acting drugs with opioids has been well established in animal studies, there is a paucity of data in well-controlled human studies. We evaluated 1014 fatality cases involving oxycodone (OXC) for evidence of enhanced toxicity associated with multiple drug-drug interactions. We previously reported on these cases, and we classified them by a standardized method into groups that distinguished cases unrelated to drug abuse from those related to drug abuse, cases that involved only OXC from cases involving multiple drugs, drug-induced fatalities from drug-related fatalities, and cases in which the specific drug product OxyContin (oxycodone HCl controlled-release) tablets were identified from cases where OxyContin was not identified. Our working hypothesis was that OXC in combination with other centrally acting drugs is more toxic than OXC alone, evidenced by the finding of lower mean blood concentrations of OXC in multiple drug-induced deaths compared to single (OXC only) drug-induced deaths. Assessment of blood levels determined by specific assay methodology (primarily gas chromatography-mass spectrometry) in these cases provided the following mean postmortem concentrations of OXC: multiple drug-induced deaths, OxyContin identified, 0.93 mg/mL (N = 167); multiple drug-induced deaths, OxyContin not identified, 0.73 mg/mL (N = 579); single (OXC) drug-induced deaths, OxyContin identified, 1.55 mg/mL (N = 12); and single (OXC) drug-induced deaths, OxyContin not identified, 1.70 mg/mL (N = 15). Overall, mean OXC concentration trends were as follows: single (OXC), drug-induced, drug abuse deaths > multiple, drug-induced drug abuse deaths > drug-related drug abuse deaths approximately deaths unrelated to drug abuse; and deaths in which OxyContin was identified approximately deaths in which OxyContin was not identified, whether the deaths involved oxycodone alone or multiple drugs. Drug abuse patterns in the multiple drug-induced cases were complex. Over 135 drugs that were considered to be plausibly contributory to enhanced toxicity were identified in body fluids and tissues. Evaluation of mean OXC blood concentrations in cases that contained one, two, three, four, five, and six or more contributory drugs in combination demonstrated consistently lower mean OXC concentrations than those cases in which OXC was the only drug identified. A smaller number of cases were evaluated in the multiple drug-induced groups in which OXC was paired with a single other contributory drug. The overall mean OXC concentration for these cases was 0.71 mg/mL (N = 90) as compared to 1.64 mg/mL (N = 27) for the cases in the single drug-induced groups. The consistent finding of lower mean OXC blood levels associated with multiple drug-induced fatalities supports the stated hypothesis that OXC in combination with other centrally active drugs is more toxic than when OXC was the only drug involved. It was concluded that in cases of multiple drug fatalities, cause of death (COD) should not be attributed to any single drug. Rather, the unique combination of drugs, the pattern of drug use/abuse, and individual factors, such as tolerance to the respiratory depressant effects of opioids, must be taken into account in arriving at a valid COD statement.

Cause of Death↗

PubMed2004

Oxycodone involvement in drug abuse deaths. II. Evidence for toxic multiple drug-drug interactions.

Recent surveys suggest that the abuse of drugs, often in combination, is pervasive throughout society. Adverse consequences of drug abuse tend to be attributed to the single drug "most likely" to be responsible. This is frequently seen in fatality cases, particularly those involving opioids. However, it is difficult to determine the specific cause of death when multiple drugs are involved. Although enhanced toxicity of alcohol and other centrally acting drugs with opioids has been well established in animal studies, there is a paucity of data in well-controlled human studies. We evaluated 1014 fatality cases involving oxycodone (OXC) for evidence of enhanced toxicity associated with multiple drug-drug interactions. We previously reported on these cases, and we classified them by a standardized method into groups that distinguished cases unrelated to drug abuse from those related to drug abuse, cases that involved only OXC from cases involving multiple drugs, drug-induced fatalities from drug-related fatalities, and cases in which the specific drug product OxyContin (oxycodone HCl controlled-release) Tablets were identified from cases where OxyContin was not identified. Our working hypothesis was that OXC in combination with other centrally acting drugs is more toxic than OXC alone, evidenced by the finding of lower mean blood concentrations of OXC in multiple-drug-induced deaths compared to single (OXC only)-drug-induced deaths. Assessment of blood levels determined by specific assay methodology (primarily gas chromatography-mass spectrometry) in these cases provided the following mean postmortem concentrations of OXC: multiple-drug-induced deaths, OxyContin identified, 0.93 microg/mL (N = 167); multiple-drug-induced deaths, OxyContin not identified, 0.73 microg/mL (N = 579); single (OXC)-drug-induced deaths, OxyContin identified, 1.55 microg/mL (N = 12); and single (OXC)-drug-induced deaths, OxyContin not identified, 1.70 microg/mL (N = 15). Overall, mean OXC concentration trends were as follows: single (OXC)-drug-induced, drug-abuse deaths > multiple-drug-induced drug-abuse deaths > drug-related drug-abuse deaths approximately deaths unrelated to drug abuse; and deaths in which OxyContin was identified approximately deaths in which OxyContin was not identified, whether the deaths involved oxycodone alone or multiple drugs. Drug abuse patterns in the multiple-drug-induced cases were complex. Over 135 drugs that were considered to be plausibly contributory to enhanced toxicity were identified in body fluids and tissues. Evaluation of mean OXC blood concentrations in cases that contained one, two, three, four, five, and six or more contributory drugs in combination demonstrated consistently lower mean OXC concentrations than those cases in which OXC was the only drug identified. A smaller number of cases were evaluated in the multiple-drug-induced groups in which OXC was paired with a single other contributory drug. The overall mean OXC concentration for these cases was 0.71 microg/mL (N = 90) as compared to 1.64 microg/mL (N = 27) for the cases in the single drug-induced groups. The consistent finding of lower mean OXC blood levels associated with multiple-drug-induced fatalities supports the stated hypothesis that OXC in combination with other centrally active drugs is more toxic than when OXC was the only drug involved. It was concluded that in cases of multiple-drug fatalities, cause of death (COD) should not be attributed to any single drug. Rather, the unique combination of drugs, the pattern of drug use/abuse, and individual factors, such as tolerance to the respiratory depressant effects of opioids, must be taken into account in arriving at a valid COD statement.

Cause of Death↗

PubMed2004

Efficacy and tolerability of cancer pain management with controlled-release oxycodone tablets in opioid-naive cancer pain patients, starting with 5 mg tablets.

BACKGROUND: We conducted an open-label, dose titration study to assess the efficacy and tolerability of controlled-release oxycodone in the therapy of cancer pain management, starting with a newly developed 5 mg tablet every 12 h. METHODS: Twenty-two Japanese cancer patients with pain who had not been taking opioid analgesics over the previous 2 weeks were enrolled. The length of time and the dose needed to attain stable and adequate pain control were evaluated in addition to the assessment of analgesic efficacy and safety during the study period. RESULTS: Eighteen patients in the efficacy population (18 out of 20, 90%) attained stable, adequate pain control. Two-thirds of the patients attained stable, adequate pain control without any dose titration. The mean length of time was 1.2 days. In these patients, the pain was significantly reduced in intensity, even at 1 h after the initial dose intake. Fifteen patients (68%) reported at least one side effect, but only one patient had to withdraw from the study because of a side effect. CONCLUSION: The results suggest that controlled-release oxycodone tablets offered stable and adequate pain control within a short period of time in most Japanese cancer patients who have not been taking opioid analgesics, and could be effectively titrated against pain from a starting dose of 5 mg every 12 h. This indicates that a lower strength controlled-release oxycodone formulation may make it possible to start and titrate the dose more appropriately and carefully in patients who are sensitive to opioid analgesics.

Aged↗

PubMedDate not supplied

A comparison of oral transmucosal fentanyl citrate and oral oxycodone for pediatric outpatient wound care.

Analgesia for pediatric burn wound care in the outpatient clinic is constrained by time, personnel, and/or monitoring capabilities, yet may improve patient satisfaction and comfort, clinic efficiency, and patient throughput. The ideal analgesic in this increasingly common setting should be palatable, provide potent, rapid, and brief analgesia, and require minimal appropriate monitoring. Using a placebo-controlled, double-blind design we compared oral transmucosal fentanyl citrate (OTFC, approximately 10 microg/kg) and oral oxycodone (0.2 mg/kg) in 22 pediatric outpatient wound care procedures (ages 5-14 years). Pulse oximetry, vital signs, side effects, patient pain scores, and observer scores for cooperation, anxiety, and sedation were recorded. OTFC and oral oxycodone resulted in similar outcome measures and vital signs, and no significant side effects. The taste of OTFC was preferred. We conclude that OTFC and oral oxycodone are safe and effective analgesics in the setting of monitored outpatient wound care in children, and that OTFC offers the advantage of improved palatability.

Administration, Oral↗

PubMed1994

Pharmacokinetics and ventilatory effects of intravenous oxycodone in postoperative children.

1. Oxycodone hydrochloride (0.1 mg kg-1) was given by intravenous bolus to 18 children after ophthalmic surgery. Plasma was sampled for up to 8 h. Blood pressure, heart rate, peripheral arteriolar oxygen saturation, end-tidal carbon dioxide and halothane concentrations and ventilatory rate were also recorded. 2. Mean (+/- s.d.) values of drug clearance and volume of distribution (Vss) were 15.2 +/- 4.2 ml min-1 kg-1 and 2.1 +/- 0.8 l kg-1. Maximum mean end-tidal carbon dioxide concentration and minimum mean ventilatory rate occurred 8 min after administration of oxycodone but the minimum mean peripheral arteriolar oxygen saturation occurred at 4 min. 3. Oxycodone (0.1 mg kg-1) appears to cause greater ventilatory depression than comparable analgesic doses of other opioids.

Child↗

PubMedDate not supplied

Toward evidence-based prescribing at end of life: a comparative analysis of sustained-release morphine, oxycodone, and transdermal fentanyl, with pain, constipation, and caregiver interaction outcomes in hospice patients.

OBJECTIVE: The primary goal of this investigation was to examine selected outcomes in hospice patients who are prescribed one of three sustained-release opioid preparations. The outcomes examined include: pain score, constipation severity, and ability of the patient to communicate with caregivers. PATIENTS AND SETTINGS: This study included 12,000 terminally ill patients consecutively admitted to hospices and receiving pharmaceutical care services between the period of July 1 and December 31, 2002. DESIGN: We retrospectively examined prescribing patterns of sustained-release morphine, oxycodone, and transdermal fentanyl. We compared individual opioids on the aforementioned outcome markers, as well as patient gender, terminal diagnosis, and median length of stay. RESULTS: Patients prescribed a sustained-release opioid had similar average ratings of pain and constipation severity, regardless of the agent chosen. Patients prescribed transdermal fentanyl were reported to have more difficulty communicating with friends and family when compared with patients prescribed either morphine or oxycodone. On average, patients prescribed transdermal fentanyl had a shorter length of stay on hospice as compared with those receiving morphine or oxycodone. CONCLUSION: There was no difference in observed pain or constipation severity among patients prescribed sustained-release opioid preparations. Patients receiving fentanyl were likely to have been prescribed the medication due to advanced illness and associated dysphagia. Diminished ability to communicate with caregivers and a shorter hospice course would be consistent with this profile. Further investigation is warranted to examine the correlation between a patient's ability to interact with caregivers and pain control achieved.

Aged↗

PubMed1989

Psychomotor, respiratory and neuroendocrinological effects of a mu-opioid receptor agonist (oxycodone) in healthy volunteers.

Psychomotor performance related to driving and occupational skills was measured double-blind and cross-over in 9 healthy volunteers before and 1.5, 3 and 4.5 hr after intramuscular injection of oxycodone (0.13 mg/kg), oral diphenhydramine (100 mg) and placebo. The effects of oxycodone on performance peaked at 1.5 hr when it prolonged reaction time and impaired vigilance, attention, body balance and coordination of extraocular muscles. The subjects assessed themselves mentally slow, muzzy and impaired by performance on visual analogue scales still 3 hr after injection. Critical flicker discrimination was impaired and some respiratory depression still present at 4.5 hr after administration. Oxycodone elevated plasma prolactin at 1.5 and 3 hr while growth hormone levels remained unaffected. We conclude that the profile of psychomotor decrement produced by this mu-opioid agonist closely resembles that of agonist-antagonist analgesics.

Adult↗

PubMed2006

Population pharmacokinetics of oxycodone in children 6 months to 7 years old.

Young children are often undertreated for pain. One barrier to effective pain treatment is understanding the pharmacokinetic behavior of analgesics in this age group. Oxycodone is a commonly prescribed opioid for severe pain, yet little is known about its pharmacokinetics in young children. This article used population pharmacokinetic modeling to synthesize pharmacokinetic data from several studies into a model. A single population model that described the observed pharmacokinetics was developed. The combined data were best described with a 2-compartment linear model with different first-order absorption rates depending on route of administration. Weight was found to significantly influence both clearance (CL) and volume of distribution (Vd). The following model adequately describes the population pharmacokinetic profile of oxycodone where absolute bioavailability (F) is estimated for each administration route: CL/F=55x(body weight/70)0.87; V/F=86x(body weight/70)1.16. The interindividual coefficients of variation in CL and Vd were 20.2 and 19.7%, respectively. This finding confirms that the allometric scaling using the above model explained most of the variability in exposure observed among children. This model confirms using a weight-based dose for oxycodone without adjustment for age between 6 months and 7 years and is valuable for evaluating dosing schedules and dosing routes.

Analgesics, Opioid↗

PubMed2001

Visual hallucination and tremor induced by sertraline and oxycodone in a bone marrow transplant patient.

The authors report a case of probable serotonin syndrome caused by the coadministration of sertraline and oxycodone. A 34 year-old male patient experienced visual hallucinations and severe tremor after dramatically increasing his dosage of oxycodone while on stable amounts of sertraline and cyclosporin. Discontinuation of cyclosporin did not result in resolution of his symptoms. Consideration of a possible sertraline-oxycodone interaction led to withholding sertraline, which resulted in symptom resolution. Serotonin syndrome has been noted with sertraline in combination with other drugs, but this is the first report in combination with a narcotic analgesic. Possible pharmacological mechanisms are discussed. In complicated patients that are taking multiple medications, physicians should be aware of this possible interaction to avoid delay in the diagnosis of serotonin syndrome.

Adult↗

PubMed2002

Comparison of the pharmacokinetics of oxycodone administered in three Percocet formulations.

This randomized, open-label, three-period crossover study compared the single-dose pharmacokinetics of three dose levels of oxycodone in combination with acetaminophen (5 mg/325 mg, 7.5 mg/500 mg, or 10 mg/650 mg) in healthy volunteers. Serial 24-hour blood samples were collectedfrom 23 fasting subjects after drug administration. The individual dose levels were evaluated on 3 different days, which were separated by washout periods of at least 7 days, in each subject. Oxycodone AUC(0-t), AUC(0-infinity), and Cmax were dose dependent, whereas tma and t(1/2) were not. The most frequently reported adverse events were dizziness, nausea, headache, pruritus, and vomiting. Most adverse events were mild, and all were self-limiting. Only dizziness occurred in a dose-related manner. Increasing dose levels of oxycodone/acetaminophen provides proportional increases in oxycodone Cmax and AUC. Adverse events were predictable based on the opioid pharmacologic actions of this agent.

Acetaminophen↗

PubMed2005

Determination of oxycodone and hydrocotarnine in cancer patient serum by high-performance liquid chromatography with electrochemical detection.

We developed an HPLC procedure using electrochemical detection for the quantitation of oxycodone and hydrocotarnine in cancer patients serum. An eluent of methanol:acetonitrile:5 mM pH 8 phosphate buffer (2:1:7) was used for the mobile phase. The calibration curve was linear in the range from 10 ng/mL to 100 ng/mL. The recovery of oxycodone and hydrocotarnine was 97.2% and 90.5%, respectively. The relative standard deviations within-runs and between-runs for the assay of oxycodone or hydrocotarnine were less than 4.8%. The method developed here was better than the method reported previously.

Analgesics, Opioid↗

PubMed2000

Ketamine and oxycodone in the management of postoperative pain.

Relief of pain, whether post-traumatic or postoperative, is a prerequisite for the prevention of its deleterious effects on the whole organism. Unalleviated pain also increases the victim's or patient's anxiety and apprehension, which in turn increase the intensity of the pain. In the management of pain, opiates have maintained their position as the most common form of analgesic therapy despite the many side effects associated with their use. This double-blind study compared the analgesic effects of low doses of racemic ketamine and the morphine derivative oxycodone on postoperative pain after elective tonsillectomy. Also, the suitability of oxycodone for field use was evaluated with respect to ketamine. Plethysmographic pulse-wave amplitude changes were compared with the pain visual analogue scale scores as measures of postoperative pain. The results of this study did not reveal any significant differences between the analgesic potencies of the studied drugs and clearly demonstrate that even suboptimal doses of both ketamine and oxycodone can provide appreciable relief of pain.

Adult↗

PubMedDate not supplied

Determination of oxycodone hydrochloride in oral solutions by high-performance thin-layer chromatography/densitometry.

A thin-layer chromatography/densitometry method was developed and validated for the determination of oxycodone hydrochloride in oral solutions by using silica gel plates. A horizontal technique was used for development of the plates. The optimum composition for the mobile phase, which provided a suitable Rf value of 0.6 for oxycodone, was propanol-acetic acid-water-25% ammonia-methanol (20 + 1 + 1 + 3 + 10). Detection was at 234 nm. Oxycodone hydrochloride was stable on the sorbent and was precisely and accurately measured in the range of 0.3-1.5 microg/band.

Analgesics, Opioid↗