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PubMed2003

Trials and tribulations: current challenges in conducting clinical trials.

Randomized controlled trials are the gold standard for the evaluation of new therapies and surgical procedures and as such require strict attention to study design and statistical analysis. There are, however, multiple challenges in conducting a well-designed clinical trial. This article describes the difficulties encountered at a single institution participating in a multicenter drug study and reviews the challenges involved in developing a high-quality randomized controlled study.

Acetaminophen↗
PubMed1982

Methodology for the identification of the urinary metabolites of the analgesic-narcotic antagonist, codorphone, by gas chromatography mass spectrometry.

Methodology is presented for the identification of codorphone and its metabolites in urine samples using gas chromatography mass spectrometry. The procedure focuses on the clean-up of biological samples and a derivatization technique suitable for these samples. Sep-Pak C-18 cartridges were employed in the clean-up procedure permitting the biological sample to be derivatized in a relatively small volume of reagents. The derivatization procedure incorporated a one-step trimethylsilyloxime reaction to prevent enol formation while simultaneously derivatizing free hydroxyl groups with the excess trimethylsilylimidazole present in the reaction mixture. This was followed by the addition of BSTFA directly to this reaction mixture to complete derivatization of any metabolites possessing dealkylation of the nitrogen. Using this derivatization scheme, synthetic metabolites were analyzed by gas chromatography mass spectrometry, and their mass spectra were characterized emphasizing the diagnostic fragment ions observed in the spectra. To illustrate the usefulness of this methodology, a urine sample obtained from a dog that had been dosed with codorphone was analyzed by gas chromatography mass spectrometry, and the metabolites were identified by comparison to the mass spectra of the synthetic derivatives.

Analgesics, Opioid↗
PubMed2006

Rapid analysis of controlled substances using desorption electrospray ionization mass spectrometry.

The recently developed technique of desorption electrospray ionization (DESI) has been applied to the rapid analysis of controlled substances. Experiments have been performed using a commercial ThermoFinnigan LCQ Advantage MAX ion-trap mass spectrometer with limited modifications. Results from the ambient sampling of licit and illicit tablets demonstrate the ability of the DESI technique to detect the main active ingredient(s) or controlled substance(s), even in the presence of other higher-concentration components. Full-scan mass spectrometry data provide preliminary identification by molecular weight determination, while rapid analysis using the tandem mass spectrometry (MS/MS) mode provides fragmentation data which, when compared to the laboratory-generated ESI-MS/MS spectral library, provide structural information and final identification of the active ingredient(s). The consecutive analysis of tablets containing different active components indicates there is no cross-contamination or interference from tablet to tablet, demonstrating the reliability of the DESI technique for rapid sampling (one tablet/min or better). Active ingredients have been detected for tablets in which the active component represents less than 1% of the total tablet weight, demonstrating the sensitivity of the technique. The real-time sampling of cannabis plant material is also presented.

Acetaminophen↗
PubMed1975

Comparison of fixed interval and visual analogue scales for rating chronic pain.

A visual analogue scale (VAS) and a 4-point scale (FPS) have been compared in patients suffering from prolonged constant pain due to chronic inflammatory or degenerative arthropathy. Each patient was treated with a constant low or high dose of paracetamol or dihydrocodeine throughout a four week period. The VAS was accurate, as reliable and more sensitive than the FPS in registering the intensity of chronic pain. Separate records of each estimate, sealed immediately on completion by the patient, resulted in omission of significantly more pain recordings on the FPS, whereas retention by the patients of their previous records did not systematically influence subsequent judgments. In this study, the VAS appeared to be more satisfactory than the FPS for patient self-rating of pain intensity.

Acetaminophen↗
PubMed1994

Dihydrocodeinone-hydrazone, dihydrocodeinone-oxime, naloxone-3-OMe-oxime, and clocinnamox fail to irreversibly inhibit opioid kappa receptor binding.

Previous work from our lab identified two subtypes of the opioid kappa receptor. Whereas the kappa1 receptor can be labeled by [3H]U69,593 (5 alpha,7 alpha,8 beta-(-)- N-methyl-N-[7-(1-pyrrolidinyl)-1-oxaspiro(4,5)dec-8-yl]-phenyl- benzeneacetamide), the kappa2 receptor can be labeled by [125I]OXY (6 beta-125iodo-3,14-dihydroxy-17-cyclopropylmethyl-4,5 alpha-epoxymorphinan). Other data demonstrate that [125I]IOXY, like [3H]bremazocine, labels two populations of kappa2 receptors in guinea pig brain: kappa2a and kappa2b binding sites. In the present study, we tested the hypothesis that certain dihydrocodeinone and oxicodone derivatives, which have been shown to irreversibly block low affinity [3H]naloxone binding sites, would also bind irreversibly to opioid kappa receptor subtypes. We also tested the novel irreversible mu receptor antagonist, clocinnamox (14 beta-(p-chlorocinnamoylamino)-7,8-dihydro-N-cyclopropylmethylno rmorphinone mesylate). Wash-resistant inhibition (WRI) assays were conducted to detect apparent irreversible inhibition. The proportion of WRI attributable to inhibition of receptor binding, termed receptor inhibition (RI), was calculated by the equation: RI = WRI (wash-resistant inhibition) - SI (supernatant inhibition or inhibition attributable to residual drug.) Dihydrocodeinone-hydrazone, dihydrocodeinone-oxime and naloxone-3-OMe-oxime failed to produce any wash-resistant inhibition of kappa receptor binding. In contrast, preincubating guinea pig membranes with 1 microM clocinnamox produced a substantial degree of wash-resistant inhibition (greater than 90%) at kappa1 and kappa2 binding sites. However, as indicated by supernatant inhibition values of 70% to 90%, there was a large amount of residual clocinnamox which remained despite the use of an extensive washing procedure.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗
PubMed2005

The GC-MS detection and characterization of neopine resulting from opium use and codeine metabolism and its potential as an opiate-product-use marker.

Neopine, a minor opium alkaloid and an isomer of codeine (also known as beta-codeine), has been detected in both the urine of opium users and pharmaceutical codeine users. The characterization of neopine was achieved by comparison of the mass spectra and GC retention times of the trimethylsilyl derivative. The presence of neopine in the urine of pharmaceutical codeine users was attributed to the metabolism of codeine through a double bond migration in ring C, from the 7-8 to the 8-14 position. The potential use of the alkaloid as a confirmation marker of opium and/or pharmaceutical codeine use and the ability to differentiate these from heroin use has been discussed.

Biomarkers↗
PubMed1997

Ambulatory laparoscopic fundoplication.

BACKGROUND: Increasingly larger series of laparoscopic fundoplications (LF) are being reported. A well-documented advantage of the laparoscopic approach is shortened hospital stay. Most centers report typical lengths of stay (LOS) for LF of 2-3 days. Our success with LF with a LOS of 1 day led to an attempt at performing LF on an ambulatory basis. METHODS: Sixty-one consecutive patients with appropriate criteria for LF underwent surgery at our institution. Patients were counseled by the authors as to the usual postop course and progression of diet. All patients received preemptive analgesia (PEA) consisting of perioperative ketorolac and preincisional local infiltration with bupivicaine. Anesthetic management included induction with propofol, high-dose inhalational anesthetics, minimizing administration of parenteral narcotics, and avoidance of reversal of neuromuscular blockade. Immediate postop pain management included parenteral ketorolac and oral hydro- or oxycodone. All patients were given oral fluids and soft solids after transfer from the recovery room to the postoperative observation unit. Two patients were excluded from ambulatory consideration due to excessive driving distance from our hospital. Another two were hospitalized for observation after experiencing intraoperative technical problems. RESULTS: Of 57 patients in whom same-day discharge was attempted, there were three failures requiring overnight hospitalization: All were due to pain and nausea; one patient also suffered transient urinary retention. There were no adverse outcomes related to early discharge, and there were no readmissions. One patient returned to the emergency room after delayed development of urinary retention. Median time from conclusion of operation to discharge was less than 5 h. No patients expressed dissatisfaction with early discharge on follow-up interview. CONCLUSIONS: LF can be safely performed as an ambulatory procedure. Analgesic and anesthetic management should be tailored to minimize nausea and provide adequate pain control.

Adult↗
PubMed2005

In-Service.

Explore the source record for details and available documents.

Analgesics, Opioid↗
PubMed2006

Tramadol/acetaminophen or hydrocodone/acetaminophen for the treatment of ankle sprain: a randomized, placebo-controlled trial.

STUDY OBJECTIVE: This randomized, multicenter study compares the analgesic efficacy and safety of tramadol/acetaminophen versus hydrocodone/acetaminophen versus placebo for the treatment of acute musculoskeletal pain caused by ankle sprain. METHODS: Adults were enrolled with ankle sprain with a diagnosis of partial ligament tear, pain visual analog scale score of 50 to 100 mm (0="no pain," 100="extreme pain"), and pain numeric rating scale score of 2 to 3 (0="none," 3="severe"). Patients reported pain intensity on these scales and pain relief (-1="pain worse," 4="complete relief") hourly for 4 hours after the first dose of tramadol/acetaminophen 75 mg/650 mg, hydrocodone/acetaminophen 7.5 mg/650 mg, or placebo, and daily for 5 days, with as-needed dosing. RESULTS: Tramadol/acetaminophen (n=192) and hydrocodone/acetaminophen (n=204) provided greater total pain relief than placebo (n=207; P<.001) during the first 4 hours (mean scores [95% confidence interval (CI)] 6.6 [95% CI 6.1 to 7.1], 6.8 [95% CI 6.3 to 7.3], and 5.4 [95% CI 4.9 to 5.9], respectively; possible range -4 to 16), decreased pain intensity during the first 4 hours, and increased average pain relief on days 1 to 5. No efficacy measure was significantly different between the tramadol/acetaminophen and hydrocodone/acetaminophen groups. Common adverse events included somnolence, nausea, dizziness, and vomiting. CONCLUSION: One or 2 capsules of 37.5 mg tramadol/325 mg acetaminophen and 1 capsule of 7.5 mg hydrocodone/650 mg acetaminophen were well tolerated, had comparable clinical utility, and were more effective than placebo in the management of acute musculoskeletal pain caused by ankle sprain.

Acetaminophen↗
PubMed2005

Major increases in opioid analgesic abuse in the United States: concerns and strategies.

The problem of abuse of and addiction to opioid analgesics has emerged as a major issue for the United States in the past decade and has worsened over the past few years. The increases in abuse of these opioids appear to reflect, in part, changes in medication prescribing practices, changes in drug formulations as well as relatively easy access via the internet. Though the use of opioid analgesics for the treatment of acute pain appears to be generally benign, long-term administration of opioids has been associated with clinically meaningful rates of abuse or addiction. Important areas of research to help with the problem of opioid analgesic abuse include the identification of clinical practices that minimize the risks of addiction, the development of guidelines for early detection and management of addiction, the development of opioid analgesics that minimize the risks for abuse, and the development of safe and effective non-opioid analgesics. With high rates of abuse of opiate analgesics among teenagers in the United States, a particularly urgent priority is the investigation of best practices for treating pain in adolescents as well as the development of prevention strategies to reduce diversion and abuse.

Analgesics, Opioid↗
PubMed2003

Withdrawal hyperalgesia after acute opioid physical dependence in nonaddicted humans: a preliminary study.

Hyperalgesia has been demonstrated to be a cardinal sign of physical withdrawal from opioids in preclinical models for more than 30 years, although few empirical data exist to support its occurrence in humans. In this preliminary study we used the acute opioid physical dependence (APD) model to test for the presence of hyperalgesia to experimental cold-pressor pain in 4 healthy non-opioid-dependent men via 3 different pretreatment opioid administration protocols previously demonstrated to induce APD (morphine 18 mg/70 kg intramuscular, morphine 10 mg/70 kg intravenous, hydromorphone 2 mg/70 kg intravenous), repeated on 2 separate occasions, and placebo. Cold-pressor pain threshold and tolerance were examined before opioid administration and 5 and 15 minutes after precipitated withdrawal with naloxone 10 mg/70 kg intravenous. Paired t tests comparing change scores between the opioid pretreatments and placebo showed that pain threshold and tolerance to the cold-pressor uniformly decreased across all APD induction methods, and the effect size was large (approximately 70% of baseline) and reproducible. These findings provide initial support for the existence of opioid-induced hyperalgesia, which has been conceptualized as a coexisting opponent process to opioid-induced analgesia and proposed to be an alternative explanation for the development of analgesic tolerance to opioids.

Acute Disease↗
PubMed2005

Palatal perforation associated with intranasal prescription narcotic abuse.

BACKGROUND: Palatal perforation resulting from insufflation of cocaine has been well documented. In comparison, reports of destructive orofacial lesions resulting from intranasal abuse of prescription narcotics are rare. We present the clinical and histologic findings in a case of palatal perforation arising in a patient abusing a prescription opioid drug. The patient denied any history of cocaine use but admitted to habitually crushing and snorting a hydrocodone/acetaminophen preparation. Study design The patient presented to our clinic seeking resolution of speech difficulties associated with an oroantral fistula. Surgical repair of the defect had been attempted unsuccessfully in the past. In addition to blood and chemistry panels, endoscopic examination was conducted, with removal of several biopsy specimens for histologic evaluation and flow cytometry. Biopsy specimens included both lesional and perilesional tissue from within the oral and nasopharyngeal cavities. Culture and cytology for fungal organisms were also performed. RESULTS: Histopathologic examination revealed normal mucosa with diffuse and focal inflammatory changes and no evidence of malignancy. Polarizable foreign material was noted in the specimens. The absence of lymphoid neoplasia was confirmed by flow cytometric analysis. The toxicology panel was positive for the presence of opiates in the blood. Culture and cytology were positive for candidal organisms. A palatal obturator was fabricated for the patient, producing significant improvement in the quality of speech. CONCLUSIONS: This may represent a case of palatal perforation resulting from abuse of a drug other than cocaine. The potential for drugs other than cocaine to produce destructive orofacial lesions should be considered.

Administration, Intranasal↗
PubMed2002

Rational use of analgesic combinations.

Careful selection of an effective analgesic regimen based on the amount and type of pain the patient is expected to have can prevent the stress and anxiety associated with breakthrough pain. When analgesics fail, it is not unusual for patients to go to desperate lengths to seek relief. The clinician can and should develop a variety of effective, safe analgesic regimens based on estimates of anticipated pain intensity that apply sound pharmacologic principles.

Acetaminophen↗