Methadone Contrasted with Acetaminophen Codeine plus Clonidine: An Inpatient Pilot Study

2021 ◽  
Vol 10 ◽  
Author(s):  
Saeed Shoja Shafti

Introduction: The mainstay of pharmacological management of opioid dependence is opioid substitution treatment. Methadone is a long‐acting opioid agonist, which is used for detoxification and maintenance of opioid-dependent people. Objective: Objective of the present evaluation included a comparison between methadone and acetaminophen codeine plus clonidine for management of opioid withdrawal symptoms. Methods: All patients of an acute ward of a psychiatric hospital, who met dual diagnosis of primary psychiatric disorder plus opioid use disorder, were selected as accessible sample for the current evaluation. Duration of assessment was around elven months and the study was performed according to a single-blind plan. Among 96 patients, cases, who were using methadone, before their recent admission in hospital, continued their substitution treatment according to the recommended dosage and formulation till release (n = 42). The remaining group of patients, had been given acetaminophen codeine plus clonidine, as substitution treatment, during their inpatient management (n = 54). The primary outcome measures were the ‘Cross-Cutting Symptom Measure’ and the ‘Subjective Opiate Withdrawal Scale’, which were scored at baseline, week 1 and week 2. The study was performed according to the ‘per-protocol’ analysis, and the assessor was blind with respect to the said protocols. Results: while the mean total score of primary outcome measures decreased significantly in both groups, the between-group analysis did not show any significant difference between these two groups in a head-to-head analysis. Conclusion: Acetaminophen codeine plus clonidine was as good as methadone for management of opioid withdrawal symptoms in inpatient setting.

2017 ◽  
Vol 44 (8) ◽  
pp. 1277-1287 ◽  
Author(s):  
Bethan L. Richards ◽  
Peter D.H. Wall ◽  
Andrew P. Sprowson ◽  
Jasvinder A. Singh ◽  
Rachelle Buchbinder

Objective.Previously published literature assessing the reporting of outcome measures used in joint replacement randomized controlled trials (RCT) has revealed disappointing results. It remains unknown whether international initiatives have led to any improvement in the quality of reporting and/or a reduction in the heterogeneity of outcome measures used. Our objective was to systematically assess and compare primary outcome measures and the risk of bias in joint replacement RCT published in 2008 and 2013.Methods.We searched MEDLINE, EMBASE, and CENTRAL for RCT investigating adult patients undergoing joint replacement surgery. Two authors independently identified eligible trials, extracted data, and assessed risk of bias using the Cochrane tool.Results.Seventy RCT (30 in 2008, 40 in 2013) met the eligibility criteria. There was no significant difference in the number of trials judged to be at low overall risk of bias (n = 6, 20%) in 2008 compared with 2013 [6 (15%); chi-square = 0.302, p = 0.75]. Significantly more trials published in 2008 did not specify a primary outcome measure (n = 25, 83%) compared with 18 trials (45%) in 2013 (chi-square = 10.6316, p = 0.001). When specified, there was significant heterogeneity in the measures used to assess primary outcomes.Conclusion.While less than a quarter of trials published in both 2008 and 2013 were judged to be at low overall risk of bias, significantly more trials published in 2013 specified a primary outcome. Although this might represent a temporal trend toward improvement, the overall frequency of primary outcome reporting and the wide heterogeneity in primary outcomes reported remain suboptimal.


Author(s):  
Ansa George ◽  
Marian Baxter

Introduction: In 2017, more than 1,200 opioid-related deaths were reported in Virginia, with slightly fewer in 2018, at 1,193 deaths. The current opioid crisis has placed a strain on an already limited number of mental health (MH) inpatient beds. The industry standard for assessment and treatment of opioid withdrawal symptoms, in the inpatient setting, is the Clinical Opiate Withdrawal Scale (COWS), and yet some units continue to utilize the Clinical Institute Withdrawal Assessment for Alcohol–Revised (CIWA-Ar) for this population. Aim: The purpose of this nurse-led performance improvement project was to implement COWS in the inpatient MH setting and improve length of stay (LOS) by 1 day. Method: In 2018, in a large federal teaching facility in the mid-Atlantic region, the COWS was implemented to replace the CIWA-Ar for opioid withdrawal, with the focus on decreasing LOS. Prior to implementation of COWS, LOS on the inpatient MH unit for opioid withdrawal was 8.6 days, which was higher than the ~6- to 7-day LOS for surrounding private sector hospitals. Individual electronic medical records were reviewed for LOS and completion of COWS and pertinent details were discussed daily with nursing staff and monthly with the interdisciplinary team. Baseline data were collected from April 2017 to March 2018, with data collection continuing through the project implementation, April to September 2018. Results: Completion of COWS on 100% of patients admitted with opioid withdrawal and a decrease in LOS from 8.6 to 4.7 days was found, a 45% reduction. Conclusion: The nurse-driven performance improvement project affected business acumen, through decreased LOS, as well as quality of care, through better symptom management.


2019 ◽  
Vol 3 (1) ◽  
pp. 24-26 ◽  
Author(s):  
Daniel Overbeek ◽  
Jonathan Abraham ◽  
Brendan Munzer

Kratom (mitragynine) is a naturally occurring opioid agonist whose use has been escalating. Its suppliers advertise it as a safe alternative for opioids and a safe treatment for opioid-withdrawal symptoms. There has been controversy in the past two years regarding the legal status and lack of regulation surrounding kratom. Currently, kratom is legal and unregulated, leaving users at risk from unpredictable potencies and effects. We present the first case of successful naloxone reversal of opioid toxidrome from recreationally used kratom. We advocate further research and regulation to ensure standardized dosing to protect patients.


2018 ◽  
Vol 46 (5) ◽  
pp. 1106-1113 ◽  
Author(s):  
Martin Kroslak ◽  
George A.C. Murrell

Background: A number of surgical techniques for managing tennis elbow have been described. One of the most frequently performed involves excising the affected portion of the extensor carpi radialis brevis (ECRB). The results of this technique, as well as most other described surgical techniques for this condition, have been reported as excellent, yet none have been compared with placebo surgery. Hypothesis: The surgical excision of the degenerative portion of the ECRB offers no additional benefit over and above placebo surgery for the management of chronic tennis elbow. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: This study investigated surgical excision of the macroscopically degenerated portion of the ECRB (surgery; n = 13) as compared with skin incision and exposure of the ECRB alone (sham; n = 13) to treat patients who had tennis elbow for >6 months and had failed at least 2 nonsurgical modalities. The primary outcome measure was defined as patient-rated frequency of elbow pain with activity at 6 months after surgery. Secondary outcome measures included patient-rated pain and functional outcomes, range of motion, epicondyle tenderness, and strength at 6 months and 2.5 years. All outcome measures up to and including the 6-month follow-up were measured in person; the longer-term questionnaire was conducted in person or over the phone. Results: The 2 groups, surgery and sham, were similar for age, sex, hand dominance, and duration of symptoms. Both procedures improved patient-rated pain frequency and severity, elbow stiffness, difficulty with picking up objects, difficulty with twisting motions, and overall elbow rating >6 months and at 2.5 years ( P < .01). Both procedures also improved epicondyle tenderness, pronation-supination range, grip strength, and modified Orthopaedic Research Institute–Tennis Elbow Testing System at 6 months ( P < .05). No significant difference was observed between the groups in any parameter at any stage. No side effects or complications were reported. The study was stopped before the calculated number of patients were enrolled (40 per group); yet, a post hoc futility analysis was conducted that showed, based on the magnitude of the differences between the groups, >6500 patients would need to be recruited per group to see a significant difference between the groups at 26 weeks in the primary outcome (patient-rated frequency of elbow pain with activity). Conclusion: With the number of available participants, this study failed to show additional benefit of the surgical excision of the degenerative portion of the ECRB over placebo surgery for the management of chronic tennis elbow.


2019 ◽  
Vol 7 (7_suppl5) ◽  
pp. 2325967119S0034
Author(s):  
Christopher Hadley ◽  
Mikayla McGrath ◽  
John P. Prodoehl ◽  
Steven B. Cohen ◽  
William D. Emper ◽  
...  

Objectives: Knee arthroscopy results in significant improvements in functional outcomes, pain and quality of life for patients suffering from meniscal tears. Traditionally, patients have undergone formal physical therapy (PT) after knee arthroscopy to regain function. Prior studies have demonstrated that patients who undergo internet-based PT after total knee arthroplasty performed as well as patients receiving traditional PT, but this has not been studied in the knee arthroscopy population. The goal of this study is to compare traditional outpatient physical therapy to internet-based physical therapy in patients undergoing knee arthroscopy for partial meniscectomy. Methods: Patients undergoing knee arthroscopy from October 2017 to September 2018 for partial meniscectomy were enrolled. Patients were randomized to either an outpatient or internet-based physical therapy program. Participants in the outpatient physical therapy were prescribed PT for 2 sessions per week for 4-6 weeks while participants in the online physical therapy group were instructed to login daily to track progress and complete their exercises a minimum of 3 times per week. Additionally, participants completed 4 questionnaires: VR-12 mental and physical health, International Knee Documentation Committee (IKDC), Modified Cincinnati Rating System (MCRS) and Lysholm pre-operatively, 1 week, 6 weeks and 6 months after surgery. The primary outcome of knee function was measured via the IKDC. Results: Of the 97 patients who met the inclusion criteria, 51 (52.6%) were in the internet-based physical therapy group and 46 (47.4%) were in the outpatient PT group. There were 57 males (58.8%) and 40 females (41.2%). Participants in the online physical therapy group logged into the platform an average of 2.74 times pre-operatively and 14.99 times post-operatively. Additionally, patients viewed their PT exercise videos, on average, 5.58 times pre-operatively and 36.71 times post-operatively. At final follow-up, there was no significant difference in the primary outcome with an average IKDC score for the online physical therapy (71.83) compared to outpatient PT group (74.23) [p = 0.699]. Additionally, there was no significant difference noted in the three secondary outcome measures between the internet-based physical therapy group and the outpatient PT group at final follow-up (Table 1). Furthermore, no significant difference was noted between the two patient cohorts pre-operatively and 1 week and 6 weeks after surgery in all four outcome measures (Table 1). Conclusion: The results of our study indicate that patients using internet-based PT had similar functional outcomes as patients using traditional outpatient PT following knee arthroscopy for partial meniscectomy. [Table: see text]


2019 ◽  
Vol 9 (7) ◽  
pp. 735-742
Author(s):  
Hui Qing Lee ◽  
Chien Yew Kow ◽  
Jay Shen Ng ◽  
Patrick Chan ◽  
Lu Ton ◽  
...  

Study Design: Ambispective observational cohort study. Objectives: Synthetic graft usage avoids morbidity associated with harvest and reduces operative time. This study aims to evaluate outcomes of anterior cervical stabilization surgery using a synthetic cage in comparison with iliac crest bone graft (ICBG) following cervical spine trauma. Methods: An ambispective review was conducted on patients from the Alfred Trauma Registry. Consecutive patients treated at a level 1 trauma center, aged 18 years and older who were treated with standalone anterior cervical stabilization following spine trauma (2011-2016) were included in the study. Primary outcome measures were patient overall satisfaction, Neck Disability Index (NDI), neck pain 10-point visual analogue scale (VAS-neck) and arm pain 10-point visual analogue scale (VAS-arm). Secondary outcome measures were radiographic evidence of fusion and rate of revision surgery. All patients had follow-up for at least 1 year. Results: Between 2011 and 2016, 114 traumatic disc levels in 104 patients were treated. ICBG was used in 32% and polyetheretherketone (PEEK) cage in 68% of the patients. Both groups had similar demographic metrics. There was no significant difference in primary outcome measures between the graft types: (1) patient satisfaction ( P = .15), (2) NDI ( P = .11), (3) VAS-neck ( P = .13), and (4) VAS-arm ( P = .20). Radiology based fusion assessment 6 months postsurgery did not show statistical significance ( P = .10). The rates of revision surgery were similar. Conclusions: This study showed no significant difference in patient-reported outcome measures when comparing the usage of PEEK cage and ICBG in anterior stand alone cervical spine stabilization. Level 1 evidence studies are required to further investigate this finding.


2021 ◽  
Author(s):  
Amir Keshavarzi ◽  
Ali Hassanalizade ◽  
Akram Ranjbar ◽  
Ali Ghaleiha ◽  
Seyed Yaser Vafaei ◽  
...  

Abstract Background Opioid withdrawal can induce oxidative stress in opioid addicts. This interventional study aimed to investigate the effect of zinc supplementation on the oxidative profile of patients with an opioid withdrawal syndrome. Methods In the current study, 40 patients aged 18 to 65 years with opioid withdrawal syndrome were randomly assigned to intervention and control groups, each with 20 subjects. In addition to standard treatment, the intervention group received 30 mg of zinc daily, while the control group was given a placebo for one month. They were evaluated using Beck Depression Inventory (BDI), Clinical Opiate Withdrawal Scale (COWS), and Young Mania Rating Scale (YMRS) for withdrawal symptoms. Moreover, other parameters included catalase (CAT), superoxide dismutase (SOD), and glutathione peroxidase (GPx) and levels of total antioxidant capacity (TAC), total thiol groups (TTG), tumor necrosis factor-α (TNF-α), and malondialdehyde (MDA). Results The rate of withdrawal symptoms (COWS) was statistically significantly lower in the treated group in comparison to the control group (P < 0.05). In the treatment group, the levels of TAC, CAT, SOD, and GPx increased significantly compared to the control group (P < 0.05). In the treatment group compared to the control group, there was a statistically significant decrease in hs-CRP, MDA, and TNFα (P < 0.05). Conclusions The results revealed that zinc supplementation could effectively reduce withdrawal symptoms by increasing antioxidant activity and reducing the lipid peroxidation index.


Author(s):  
Mahboubeh Firouzkouhi Moghadam ◽  
Nour-Mohammad Bakhshani ◽  
Alireza Noroozi ◽  
Farnaz Sharifi Mood ◽  
Shahab Lotfinia

Background: There is an increasing trend in treatment demand for opioid dependence among adolescents in Iran. However, evidence regarding effective treatment in this population is very limited. Objectives: This study aimed to compare the efficacy of clonidine and buprenorphine for inpatient medically-assisted withdrawal of adolescents with opioid dependence aged 12 and 16 years. Materials and Methods: The study is an open-label, randomized controlled trial with convenience sampling. In total, 36 adolescents took part in this study who were randomly assigned to buprenorphine or clonidine groups. The Clinical Opiate Withdrawal Scale was used to monitor the withdrawal severity on days one, two, three, seven, and 14. Results: The findings showed both treatments were effective. However, withdrawal symptoms in the buprenorphine group showed a greater reduction in the first seven days of withdrawal treatment. There was no significant difference in the length of hospitalization between the two groups. Patients with a longer duration of opioid use showed higher levels of withdrawal symptoms in the buprenorphine group on days one and three. Conclusions: Buprenorphine treatment was found to be more effective than clonidine in controlling opioid withdrawal during the initial days of treatment. However, it lost its superiority towards the end of the follow-up. It seems that clonidine could be a good alternative to buprenorphine in the medically-assisted withdrawal of adolescents with opioid dependence.


2011 ◽  
Vol 4;14 (4;7) ◽  
pp. 391-406
Author(s):  
Franklin Johnson

Background: Morphine sulfate and naltrexone hydrochloride extended-release capsules (EMBEDA, King Pharmaceuticals, Inc., Bristol, TN), indicated for management of chronic, moderate-to-severe pain, contain pellets of extended-release morphine sulfate with a sequestered naltrexone core (MS-sNT). Taken as directed, morphine provides analgesia while naltrexone remains sequestered; if tampered with by crushing, naltrexone is released to mitigate morphine-induced euphoric effects. While it is necessary to establish that formulations intended to reduce attractiveness for abuse are successful in doing so, it is also necessary to demonstrate that product therapeutic integrity is maintained for patients. Objectives: Data were reviewed from 3 studies to determine: 1) the quantity of naltrexone released when MS-sNT pellets are crushed (MS-sNTC) for at least 2 minutes with mortar and pestle); 2) the extent to which the naltrexone released upon crushing mitigated morphine-induced subjective effects; and 3) whether sequestered naltrexone precipitates opioid withdrawal when MSsNT is taken as directed. Methods: The naltrexone bioavailability study compared naltrexone release from MS-sNTC with that from whole intact MS-sNT capsules (MS-sNTW) and an equal naltrexone solution (NS) dose. Equivalent bioavailability was established if 90% confidence intervals (CIs) for geometric mean ratios (maximum plasma naltrexone concentration [Cmax] and area under the concentration-time curve extrapolated to infinity [AUC∞]) fell between 80% and 125%. The oral pharmacodynamic study assessed drug liking and euphoria and pharmacokinetic properties of MS-sNTC and MS-sNTW compared with morphine sulfate solution (MSS) and placebo. The 12-month, open-label (OL) safety study evaluated safety of MS-sNT administered orally as directed in patients with chronic, moderate-to-severe pain. Safety assessments included withdrawal symptoms based on the Clinical Opiate Withdrawal Scale (COWS). Results: Naltrexone from MS-sNTC met criteria for equivalent bioavailability to NS. Although morphine relative bioavailability was similar for MS-sNTC and MSS, mean peak (Emax) visual analog scale (VAS) scores for drug liking and Cole/Addiction Research Center Inventory Stimulation-Euphoria were significantly reduced for MS-sNTC vs MSS (P < 0.001). In these 2 studies, a total of 6 participants had one measurement of plasma naltrexone after MS-sNTW that was above the lower limit of quantification. In the OL safety study, 72/93 participants (77%) had no quantifiable naltrexone concentrations. There was neither evidence of naltrexone accumulation for any participant nor any significant correlation with MSsNT dose, age, or sex. Of 4 participants with the highest naltrexone concentrations, none had COWS scores consistent with moderate opioid withdrawal symptoms. Only 5 participants had COWS scores consistent with moderate opioid withdrawal; all 5 had not taken MS-sNT as directed. Limitations: Study populations may not be fully representative of patients receiving opioid therapy for the management of chronic, moderate-to-severe pain and of opioid abusers. Conclusions: When MS-sNT capsules are crushed, all of the sequestered naltrexone (relative to oral NS) is released and immediately available to mitigate morphine-induced effects. When MSsNT was crushed, the naltrexone released abated drug liking and euphoria relative to that from an equal dose of immediate-release morphine from MSS administration in a majority of participants. Naltrexone concentrations were low over a period of 12 months without evidence of accumulation, and there were no observable opioid withdrawal symptoms when MS-sNT was taken as directed. Key words: Chronic pain, drug liking, euphoria, extended-release opioids, morphine, naltrexone, opioid withdrawal, pharmacodynamics, pharmacokinetics


2018 ◽  
Vol 53 (3) ◽  
pp. 261-267 ◽  
Author(s):  
Meredith L. Howard ◽  
Roya Hossaini ◽  
Catherine Tolar ◽  
Marian L. Gaviola

Background: Hospitalized patients are subject to acute illness and stress which may impact appetite or weight. Loss of appetite may lead to increased morbidity or mortality. Medications such as dronabinol, megestrol, and mirtazapine are used for weight gain in the outpatient setting; however, there is limited information about safety or effectiveness when initiated inpatient. Objectives: To analyze the effectiveness and safety of appetite-stimulating medications in hospitalized patients. Methods: This was a retrospective cohort study of hospitalized patients initiated on dronabinol, megestrol, or mirtazapine for appetite. The primary outcome was change in meal intake between drug initiation and discontinuation. Secondary outcomes included documented improvement in appetite, change in weight and various laboratory parameters, and incidence of adverse effects. Results: A total of 38 patients met inclusion criteria, and mirtazapine was most commonly used (42%). There was no significant difference between groups of appetite-stimulating medications with regard to mean change in meal intake, weight, albumin, or documented improvement in diet. Within groups, each agent showed numerical improvement in percentage meal intake, with a mean change from initiation to discontinuation of 17.12%. Almost half (48%) of the patients experienced improvement in diet after the start of medications. No serious adverse effects were observed. Conclusion and Relevance: In inpatients, there was no difference in change in meal intake or weight between dronabinol, megestrol, or mirtazapine, but they may show numerical improvements in meal intake. To our knowledge, this is the first study to evaluate the use of dronabinol, megestrol, and mirtazapine initiated in the inpatient setting.


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