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"Analgesics - adverse effects"
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Morphine, Gabapentin, or Their Combination for Neuropathic Pain
In a randomized trial, the combination of morphine and gabapentin led to better pain control than either agent alone in patients with diabetic neuropathy or postherpetic neuralgia. The dose of each agent was lower when used in combination than when used alone. Adverse effects were not more severe with the combined formulation.
The combination of morphine and gabapentin led to better pain control than either agent alone in patients with diabetic neuropathy or postherpetic neuralgia.
Neuropathic pain is a common complication of cancer, diabetes mellitus, degenerative spine disease, infection with the human immunodeficiency virus, the acquired immunodeficiency syndrome, and other infectious diseases, and it has a profound effect on quality of life and expenditures for health care.
1
Gabapentin and opioids have been proposed as two of several first-line treatments for neuropathic pain.
2
However, the maximal tolerated doses of these drugs, administered as single agents, reduce pain by only 26 to 38 percent, owing to incomplete efficacy, dose-limiting adverse effects, or both.
3
–
6
The combination of mechanistically distinct analgesic agents may result in additivity or synergism . . .
Journal Article
Oral ketamine for acute postoperative analgesia (OKAPA) trial: A randomized controlled, single center pilot study
Although opioids represent the mainstay of treating surgical pain, their use is associated with significant side effects. There is an urgent need to find new pain relievers with safer side effect profiles. One drug that has been receiving increasing attention is ketamine. By using the oral route of administration, ketamine could potentially be used by patients in a less resource-intensive manner with similar efficacy. This study aims to examine the role of oral ketamine in improving recovery after major spine surgery.
A prospective, single-center, double blinded parallel arm, placebo controlled randomized feasibility trial.
Toronto Western Hospital (TWH), UHN, Toronto, Canada.
Adult patients (aged 18–75) undergoing multi-level lumbar spine decompression and fusion with planned overnight admission in hospital.
Study treatment (oral ketamine 30 mg) or matching placebo for three days (nine doses total) or until hospital discharge.
The primary outcome was the patient-reported Quality of Recovery-15 score (QoR-15). Secondary outcomes were opioid use, pain intensity, pain interference (PROMIS-pain interference questionnaire), mood (PHQ-9) and, side-effects (Generic Assessment of Side Effects Scale).
Data from 35 patients were analyzed, of which 18 patients in the ketamine group and 17 patients in the placebo group. There were no significant differences identified in QoR-15 scores at postoperative days 1,3,7, and 30. There were also no significant differences found in pain intensity scale scores at postoperative days 1, 3, 7, and 30, and PROMIS and PHQ-9 scores at postoperative days 7 and 30. Significantly less oral opioids were used in the ketamine group compared to the placebo group on postoperative day 3 and by postoperative day 7. In addition, patients in the ketamine group spent significantly less days on oral opioids and trended to be discharged from hospital earlier.
This pilot study demonstrated that low dose oral ketamine can be safely used as an adjunct in postoperative pain treatment to help reduce opioid consumption after major spine surgery.
•Although opioids represent the mainstay of treating surgical pain, their use is associated with significant side effects.•Low dose oral ketamine can be safely used as an adjunct in postoperative pain treatment.•Ketamine can more effectively reduce symptoms of pain hypersensitivity, including allodynia and hyperalgesia.
Journal Article
Oxycodone–paracetamol tablet exhibits increased analgesic efficacy for acute postoperative pain, higher satisfaction and comparable safety profiles compared with celecoxib in patients underwent arthroscopic knee surgery
This randomized, controlled study compared the efficacy and safety between oxycodone–paracetamol tablet and celecoxib for postoperative analgesia in patients who underwent arthroscopic knee surgery (AKS). Totally, 232 patients scheduled to undergo AKS were enrolled and were randomly assigned to either the oxycodone–paracetamol (OPT group) or the celecoxib group (CEL group). Pain at rest/motion (based on pain visual analog scale (VAS) score), rescue analgesia consumption, satisfaction level and adverse events were assessed after AKS. Pain VAS score at rest was decreased at 6 h, 12 h post-AKS in the OPT group compared with the CEL group. Similarly, pain VAS score at motion was reduced at 6 h, 12 h, 24 h post-AKS in the OPT group compared to the CEL group. Furthermore, both rescue analgesia rate (14.7% vs
.
33.6%) and accumulated pethidine consumption (3.7 ± 8.9 mg vs
.
14.0 ± 21.2 mg) were lower in OPT group compared with the CEL group. Patients satisfaction score was either at 24 h, 48 h in OPT group compared with the CEL group. Further subgroup analyses indicated that the effect of oxycodone–paracetamol versus (vs
.
celecoxib) on post-AKS management was more apparent in the elderly patients and male patients. In addition, the adverse events were well tolerable (including nausea, constipation, vomiting, drowsiness and dizziness) and were of no different between the two groups. In conclusion, oxycodone–paracetamol tablet presents increased analgesic efficacy for acute postoperative pain, with higher patient satisfaction and comparable safety profiles compared with celecoxib in patients underwent AKS.
Journal Article
The Effect of Intraoperative Dexmedetomidine Versus Morphine on Postoperative Morphine Requirements After Laparoscopic Bariatric Surgery
BackgroundDexmedetomidine is an α2 receptor agonist with sedative and analgesic properties. During bariatric surgery, its use may reduce postoperative opioid requirements, reduce their side effects, and improve quality of recovery.The aim of this prospective randomized controlled trial was to compare the effect of dexmedetomidine bolus and infusion versus morphine bolus given prior to the end of laparoscopic bariatric surgery.MethodsSixty morbidly obese patients (BMI > 40 kg m−2) aged 18 to 60 years, undergoing laparoscopic sleeve gastrectomy, received morphine sulfate (bolus 0.08 mg kg−1 followed by a saline infusion) (group M, n = 30) or dexmedetomidine (loading dose of 1 μg kg−1 followed by 0.5 μg kg−1 h−1) (group D, n = 30) 30 min before the end of surgery.Data collected included morphine consumption in the post-anesthesia care unit (PACU) (primary outcome) and at 24 h, pain intensity, nausea, heart rate, blood pressure, vomiting, sedation, and quality of recovery.ResultsThere was no significant difference in morphine consumption in the PACU (group D 12.2 ± 5.44 mg, group M 13.28 ± 6.64 mg, P = 0.54) or at 24 h (group D 40.67 ± 24.78 mg, group M 43.28 ± 27.79 mg, P = 0.75); when accounting for intraoperative morphine given group M had significantly higher morphine consumption when compared to group D (23.48 ± 6.22 mg vs. 12.22 ± 5.54 mg, respectively, P < 0.01). Group D patients had more cardiovascular stability.ConclusionsDexmedetomidine given prior to end of laparoscopic sleeve gastrectomy provides the same level of postoperative analgesia as morphine with better hemodynamic profile.
Journal Article
The effect of pre-emptive oral pregabalin on opioid consumption in patients undergoing laparoscopic sleeve gastrectomy with an analysis of intraoperative hemodynamic stability and quality of recovery: study protocol for a randomized, prospective, double-blind study
Background
Obese patients undergoing laparoscopic sleeve gastrectomy (LSG) are particularly at risk of opioid-related side effects. To reduce patient exposure to opioids, multimodal analgesia, which involves the use of drugs of different classes, may be utilized. One of the drugs under consideration is pregabalin. Despite an opioid-sparing potential, few studies assess the role of pregabalin as an element of multimodal analgesia in LSG. Considering the limited number and inconsistent results of available studies, we decided to conduct a randomized, prospective study on the effect of preemptive pregabalin administration in obese patients on opioid consumption, pain scores, the incidence of opioid side effects, and hemodynamical stability.
Methods
The study is designed as a prospective randomized controlled trial with double-blinding. Randomization will be performed in a block with a parallel 1:1 allocation. The intervention will involve receiving a pregabalin 150 mg capsule 1–2 h before the surgery, whereas the control group will receive an identically looking placebo. The primary outcome measure will be total oxycodone consumption in the first 24 h following surgery. Secondary outcome measures will be pain severity assessed using the Numerical Rating Scale (NRS) 1, 6, 12, and 24 h after surgery, postoperative sedation on the Ramsay scale, PONV impact scale, the incidence of desaturation episodes < 94%, and episodes of blurred vision at 1, 6, 12, and 24 h after surgery, intraoperative hemodynamic parameters such as heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), total fluid volume, and total ephedrine dose. Patient comfort will be additionally assessed using the QoR-40 questionnaire at discharge.
Discussion
The study will explore the efficacy and safety of preemptive pregabalin in a dose of 150 mg as a co-analgesic used in multimodal analgesia for LSG. As studies on opioid-sparing regimes concern the safety of obese patients, we aim to contribute objective data with a relatively large study sample size. The result of the present clinical trial may support the reassessment of recommendations to use pregabalin in the studied population.
Trial registration
ClinicalTrials.gov NCT05804591. Registered on 07.04.2023.
Journal Article
Pre-emptive analgesia with methylprednisolone and gabapentin in total knee arthroplasty in the elderly
The aim of this study is to assess whether administration of gabapentin and methylprednisolone as “pre-emptive analgesia” in a group of patients above 65 years of age would be effective in complex pain management therapy following total knee arthroplasty (TKA). One hundred seventy patients above 65 years were qualified for the study, with exclusion of 10 patients due to clinical circumstances. One hundred sixty patients were randomly double-blinded into two groups: the study group (80 patients) and the control group (80 patients). The study group received as “pre-emptive” analgesia a single dose of 300 mg oral (PO) gabapentin and 125 mg intravenous (IV) methylprednisolone, while the control received a placebo. All patients received opioid and non-opioid analgesic agents perioperatively calculated for 1 kg of total body weight. We measured (1) pain intensity level at rest (numerical rating scale, NRS), (2) life parameters, (3) levels of inflammatory markers (leukocytosis, C reactive protein CRP), and (4) all complications. Following administration of gabapentin and methylprednisolone as “pre-emptive” analgesia, the NRS score at rest was calculated at 6, 12 (p < 0.000001), 18 (p < 0.00004) and 24 (p = 0.005569) h postoperatively. Methylprednisolone with gabapentin significantly decreased the dose of parenteral opioid preparations (p = 0.000006). The duration time of analgesia was significantly longer in study group (p < 0.000001), with CRP values lower on all postoperative days (1, 2 days—p < 0.00001, 3 days—p = 0.00538), and leukocytosis on day 2 (p < 0.0086) and 3 (p < 0.00042). No infectious complications were observed in the first postoperative days; in the control group, one patient manifested transient ischemic attack (TIA). The use of gabapentin and methylprednisolone as a single dose decreased the level of postoperative pain on the day of surgery, the dose of opioid analgesic preparations, and the level of inflammatory parameters without infectious processes.
Journal Article
The efficacy and safety of patient-controlled intravenous analgesia with esketamine after total hip arthroplasty: a randomized controlled trial
Purpose
To evaluate the efficacy and safety of esketamine-based patient-controlled intravenous analgesia following total hip arthroplasty.
Methods
A total of 135 total hip arthroplasty patients were randomly assigned to one of the three treatment groups: esketamine, sufentanil or continuous fascia iliaca compartment block (FICB) group. The primary endpoint was the postoperative visual analogue scale (VAS) pain scores at rest and on movement. Secondary endpoints included preoperative 1-day and postoperative 7-day Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) scores, the satisfaction of patients and surgeons, postoperative 1-month and 3-month Harris function scores, the incidence of adverse reactions.
Results
At 48 h post-surgery, the VAS pain scores in the esketamine and FICB groups at rest and on movement were significantly lower than those in the sufentanil group (
P
< 0.05). The satisfaction of patients in the esketamine group was higher than that in the sufentanil and FICB groups (
P
= 0.014). The satisfaction of surgeons in the esketamine and FICB groups was higher than that in the sufentanil group (
P
= 0.002). At postoperative day 7, the SAS scores and SDS scores in the esketamine group were significantly lower than those in the sufentanil and FICB groups (
P
< 0.05). Compared with the sufentanil group, the postoperative nausea and vomiting, dizziness and total adverse reactions in the esketamine group and FICB group were lower (
P
< 0.05).
Conclusion
Patient-controlled intravenous analgesia with esketamine has the potential to provide good postoperative analgesia for total hip arthroplasty patients, reduce the incidence of adverse reactions after the operation, improve the satisfaction of patients and surgeons, and significantly improve patients’ postoperative mood.
Trial registration
: ChiCTR2300069632 (
https://www.chictr.org.cn/
) (March 22th, 2023).
Journal Article
Optimizing the use of ketamine to reduce chronic postsurgical pain in women undergoing mastectomy for oncologic indication: study protocol for the KALPAS multicenter randomized controlled trial
Background
Mastectomies are commonly performed and strongly associated with chronic postsurgical pain (CPSP), more specifically termed postmastectomy pain syndrome (PMPS), with 25–60% of patients reporting pain 3 months after surgery. PMPS interferes with function, recovery, and compliance with adjuvant therapy. Importantly, it is associated with chronic opioid use, as a recent study showed that 1 in 10 patients continue to use opioids at least 3 months after curative surgery. The majority of PMPS patients are women, and, over the past 10 years, women have outpaced men in the rate of growth in opioid dependence. Standard perioperative multimodal analgesia is only modestly effective in prevention of CPSP. Thus, interventions to reduce CPSP and PMPS are urgently needed. Ketamine is well known to improve pain and reduce opioid use in the acute postoperative period. Additionally, ketamine has been shown to control mood in studies of anxiety and depression. By targeting acute pain and improving mood in the perioperative period, ketamine may be able to prevent the development of CPSP.
Methods
Ketamine analgesia for long-lasting pain relief after surgery (KALPAS) is a phase 3, multicenter, randomized, placebo-controlled, double-blind trial to study the effectiveness of ketamine in reducing PMPS. The study compares continuous perioperative ketamine infusion vs single-dose ketamine in the postanesthesia care unit vs placebo for reducing PMPS. Participants are followed for 1 year after surgery. The primary outcome is pain at the surgical site at 3 months after the index surgery as assessed with the Brief Pain Inventory-short form pain severity subscale.
Discussion
This project is part of the NIH Helping to End Addiction Long-term (HEAL) Initiative, a nationwide effort to address the opioid public health crisis. This study can substantially impact perioperative pain management and can contribute significantly to combatting the opioid epidemic.
Trial registration
ClinicalTrials.gov NCT05037123. Registered on September 8, 2021.
Journal Article