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Comparing the Efficacy of Peritonsillar Injection of Tramadol With Honey in Controlling Post-Tonsillectomy Pain in Adults.
Hatami, M, Mirjalili, M, Ayatollahi, V, Vaziribozorg, S, Zand, V
The Journal of craniofacial surgery. 2018;(4):e384-e387
Abstract
INTRODUCTION The authors investigated the effect of honey on post-tonsillectomy pain and compare its efficacy with tramadol. METHODS This clinical trial was performed on 60 patients with American Society of Anesthesia I and II aged between 18 and 55 years and underwent tonsillectomy. Induction of anesthesia was carried out using 2 mg/kg propofol and 0.5 atracurium following 1.5 μg/kg fentanyl administration. Group B was given tramadol at dose of 2 mg/kg and with volume of 4 mL and Group A was given normal saline with the same volume 2 mL of medications were injected using needle (25) into tonsil bed and anterior old of each tonsil by an anesthesiologist. Three minutes after injection, the surgery was performed by the same ENT residents for all patients. In the recovery room Group B received antibiotics and oral acetaminophen. Group A was given antibiotics, oral acetaminophen, and honey dissolved in 40 mL warm water every 6 hours from when the patient was fully awake. Patients in Group A were told to eat honey 3 times a day 7 days postoperatively. Pain was scored using Numeric Rating Scale at the time points of 2, 6, 12, and 24 hours as well as 3 and 7 days postoperatively. Moreover, the healing status and epithelialization degree of tonsillar bed were considered on 1 and 7 days after the surgery by ENT specialist. RESULTS The mean of pain score was significantly higher in Group A within 24 hours postoperatively as compared with Group B (P < 0.01). The mean of pain score was lower in Group B after 3 and 7 days but this difference was not statistically significant (P > 0.05). Considering restoration status and epithelialization degree of tonsillar bed on the 1st and 7th days, there was no statistically significant difference between 2 groups; however, tonsillar bed healing process was better in Group B on the 7th day. CONCLUSION The current investigation confirmed the positive impact of tramadol on post-tonsillectomy pain relief in adults. The authors also found that honey can be used as a complementary treatment along with acetaminophen and other analgesics for reducing post-tonsillectomy pain. Considering honey impact on wound healing and its anti-inflammatory effect, it is suggested for relieving complications after surgery.
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A Pooled Analysis Evaluating Renal Safety in Placebo- and Active Comparator-Controlled Phase III Trials of Multiple-Dose Injectable HPβCD-Diclofenac in Subjects with Acute Postoperative Pain.
Daniels, SE, Gan, TJ, Hamilton, DA, Singla, N, Lacouture, PG, Johnson, O, Min, LH, Reyes, CR, Carr, DB
Pain medicine (Malden, Mass.). 2016;(12):2378-2388
Abstract
OBJECTIVE : While injectable nonsteroidal anti-inflammatory drugs (NSAIDs) are a key component of postoperative multimodal analgesia, renal safety concerns may limit use in some patients. This study examined the renal safety of injectable HPβCD-diclofenac when given for ≤ 5 days following orthopedic or abdominal/pelvic surgery. METHODS : Pooled analysis of data from two randomized, placebo- and active comparator-controlled phase III trials in 608 total patients was conducted. Renal safety was assessed by examining treatment-emergent adverse events (AEs) and postoperative blood urea nitrogen (BUN) and serum creatinine shifts. RESULTS : There were three renal AEs each in the HPβCD-diclofenac (n = 318 patients) and placebo (n = 148 patients) groups, and two renal AEs in the ketorolac group (n = 142 patients). No significant difference in renal AE risk was detected for patients receiving HPβCD-diclofenac (RR: 1.40 [0.15,13.3]; P = 0.75) or ketorolac (RR: 2.08 [0.19,22.7]; P = 0.56) versus placebo. All renal AEs were mild or moderate in severity, and a single renal AE (acute renal failure in a patient receiving HPβCD-diclofenac) was treatment-related. One incidence of postoperative shift to high (> upper limit of normal) serum creatinine occurred in the HPβCD-diclofenac group (n = 2 in the ketorolac group). Mean changes in serum creatinine or BUN did not differ significantly between patients receiving HPβCD-diclofenac and placebo. CONCLUSIONS : While this analysis examined relatively brief exposure typical for parenterally administered analgesics in the postoperative setting in patients with largely normal renal function, the results suggest that HPβCD-diclofenac use for acute postoperative pain may not be associated with added renal safety risks over placebo in this patient population.
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Cardiovascular safety of hydroxypropyl-β-cyclodextrin-diclofenac in the management of acute postsurgical pain: a pooled analysis of 2 randomized, double-blind, placebo- and active comparator-controlled phase III clinical trials.
Gan, TJ, Singla, N, Daniels, SE, Lacouture, PG, Min, LH, Reyes, CR, Carr, DB
Journal of clinical anesthesia. 2016;:249-58
Abstract
STUDY OBJECTIVE Long-term use of nonsteroidal anti-inflammatory drugs, including selective and nonselective cyclooxygenase inhibitors, has been suggested to be associated with cardiovascular (CV) safety risks. Data are limited regarding CV risks associated with short-term nonsteroidal anti-inflammatory drug use, including injectable formulations, although it has been suggested that even a single dose may increase CV adverse event (AE) risk. The objective of this study was to examine the CV safety of an injectable diclofenac formulation solubilized with hydroxypropyl-β-cyclodextrin (HPβCD) when given for ≤5days postoperatively. DESIGN A pooled analysis of CV AEs from 2 pivotal phase III clinical trials examining the efficacy and safety of intravenous (IV) HPβCD-diclofenac vs placebo and the active comparator ketorolac was conducted. SETTING Postoperative, with treatment initiated in the postanesthesia care unit ≤6hours postsurgery. PATIENTS Overall, 608 abdominal/pelvic and orthopedic surgery patients met inclusion criteria and received ≥1 study medication dose. INTERVENTIONS Patients received either HPβCD-diclofenac, ketorolac, or placebo via IV bolus injection every 6hours, for ≤5days postsurgery. MEASUREMENTS CV AEs, reported by study investigators, were evaluated through the treatment period and follow-up (≤37days after last study medication dose), and relative CV AE risks were estimated. MAIN RESULTS IV HPβCD-diclofenac was not associated with increased treatment-emergent CV AE incidence vs placebo (11.6% vs 12.2%; relative risk, 0.96 [95% confidence interval, 0.56-1.62]). Serious CV AEs as well as treatment-related AEs were uncommon, and there were no reports of myocardial infarction or cerebrovascular accident. CV AEs were uncommon during the follow-up period, occurring in 1.3%, 0%, and 1.4% of patients in the HPβCD-diclofenac, ketorolac, and placebo groups, respectively. CONCLUSIONS Although a longer duration follow-up study in a larger patient population would expand our understanding of potential CV risks, the present analysis suggests that postoperative use of HPβCD-diclofenac does not present an added CV safety risk over placebo.
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Intracameral phenylephrine and ketorolac during cataract surgery to maintain intraoperative mydriasis and reduce postoperative ocular pain: Integrated results from 2 pivotal phase 3 studies.
Hovanesian, JA, Sheppard, JD, Trattler, WB, Gayton, JL, Malhotra, RP, Schaaf, DT, Ng, E, Dunn, SH
Journal of cataract and refractive surgery. 2015;(10):2060-8
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Abstract
PURPOSE To evaluate the efficacy and safety of phenylephrine 1.0%-ketorolac 0.3% (Omidria) for maintenance of mydriasis during, and reduction of ocular pain after, cataract surgery. SETTING Twenty centers in the United States and the Netherlands. DESIGN Prospective randomized clinical trials. METHODS Patients having cataract surgery or refractive lens exchange were enrolled in 2 clinical trials. Phenylephrine 1.0%-ketorolac 0.3% or placebo was added to irrigation solution and administered intracamerally during the procedure. Integrated analyses of primary and secondary endpoints were conducted. RESULTS The clinical trials comprised 808 patients (403 treatment and 405 placebo). Phenylephrine 1.0%-ketorolac 0.3% was superior to placebo for the maintenance of mydriasis during, and reduction of ocular pain following, cataract surgery. The mean area under the curve (AUC) change from baseline in pupil diameter was 0.08 mm for treatment compared with -0.50 mm for placebo (P < .0001). The mean AUC of ocular pain visual analog scale scores within 12 hours postoperatively was 4.16 mm for the treatment group and 9.06 mm for the placebo group (P < .001). Results of all secondary efficacy analyses demonstrated a significant treatment effect associated with phenylephrine 1.0%-ketorolac 0.3%. Treatment-emergent adverse events were as expected for a population having cataract surgery; no clinically significant differences in safety measures were observed between treatment groups. CONCLUSION In this integrated analysis, phenylephrine 1.0%-ketorolac 0.3% administered intracamerally with irrigation solution during cataract surgery was safe and effective for maintaining mydriasis during the procedure and reducing postoperative ocular pain. FINANCIAL DISCLOSURE Dr. Schaaf is an employee and holds an equity interest in Omeros Corporation. Drs. Hovanesian, Sheppard, Trattler, Gayton, and Ng are consultants to Omeros Corporation. No other author has a financial or proprietary interest in any material or method mentioned.
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Acceptable effect of multimodal analgesic treatment after a Bascom cleft lift operation.
Mohamed, SJ, Kristensen, BB, Lindgaard, L, Bisgaard, T
Danish medical journal. 2015;(1):A4985
Abstract
INTRODUCTION Information on multimodal analgesic efficacy in patients undergoing a Bascom cleft lift operation is limited. The aim of this prospective consecutive study was to evaluate early post-operative pain in patients receiving a standardised multimodal analgesic regimen. METHODS A total of 48 patients undergoing a Bascom cleft lift operation were included over an 8-month period in a day-case set-up. The operation was performed under saddle block. In addition, patients received a standardised multi-modal analgesic regimen consisting of gabapentin, ketorolac, dexamethasone, acetaminophen (paracetamol) and ibuprofen. The intensity of pain was registered preoperatively and at 2, 24, 48 h, and 30 days post-operatively. Nausea, vomiting, dizziness, ability to void, morphine consumption and post-anaesthesia care unit (PACU) time were registered. RESULTS Thirty patients were available for analysis. Post-operative visual analogue scale pain scores were low (at 2, 24, and 48 h (median values: 0 (range: 0-40), 25 (0-70), and 30 (0-60), respectively), but changed significantly over time (p < 0.001). The median overall morphine consumption was 0 (range: 0-30). None of the patients experienced vomiting or dizziness. Only two patients reported mild nausea during the stay in the PACU. CONCLUSION This study suggests that the Bascom cleft lift operation is feasible with minimal post-operative pain when using a multimodal analgesic regimen together with saddle block. FUNDING not relevant. TRIAL REGISTRATION ClinicalTrials.gov: NCT02196727. Regional Ethics Committee Reg. no.: H-3-2013-073. Danish Data Protection Agency Reg. no.: HVH-2013-031, with I-Suite no.: 02408.
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[Postoperative analgesia with nefopam and non-steroidal anti-inflammatory drugs in patients after surgery for tumors of head and neck].
Balandin, VV, Gorobets, ES
Anesteziologiia i reanimatologiia. 2014;(1):40-3
Abstract
MATERIALS AND METHODS 83 adult patients included in the study were divided into two groups. Patients of the group-1 (n-49) had medium level of pain after cancer head and neck surgery. Patients of the group-2 (n-34) had severe pain. Three first postoperative days their post-operative multimodal analgesia started with tenoxycam 20 mg i.m. after induction of anesthesia, then every 24 hour (58 patients). 25 patients got ketoprofen 100 mg i.m. every 8-12 hours instead of tenoxycam. All patients had nefopam 30 mg i.m. 30 min prior the end of surgery procedure, and every 8 hours afterwards. 7 patients of the group-1 had more than 4 pain scores (day 1), 4 patients--at the day 2. They received tramadol or paracetamol additionally. 7 patients (group-2) also had up to 5 pain scores on the day 1, 5 patients had 4 pain scores on the day 2, and 3 patients 4 pain scores on the day 3. All that patients received additional analgesia with tramadol or trimeperidine once a day. 8.4% of patients suffered from adverse reactions (tachycardia, PONV and sweating). CONCLUSION This method of multimodal postoperative analgesia is very simple and fairly efficient.
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Predictive models of pain following root canal treatment: a prospective clinical study.
Arias, A, de la Macorra, JC, Hidalgo, JJ, Azabal, M
International endodontic journal. 2013;(8):784-93
Abstract
AIM: To determine the probability of the incidence, intensity, duration and triggering of post-endodontic pain, considering factors related to the patient (age, gender, medical evaluation) and to the affected tooth (group, location, number of canals, pulp vitality, preoperative pain, periapical radiolucencies, previous emergency access, presence of occlusal contacts with antagonist). METHODOLOGY A total of 500 one-visit root canal treatments (RCTs) were performed on patients referred to an endodontist. Shaping of root canals was performed manually with Gates-Glidden drills and K-Flexofiles, and apical patency was maintained with a size 10 file. A 5% NaOCl solution was used for irrigation, and canals were filled with lateral compaction and AH-Plus sealer. Independent factors were recorded during the treatment, and characteristics of post-endodontic pain (incidence, intensity, type and duration) were later surveyed through questionnaires. Of the 500 questionnaires, 374 were properly returned and split in two groups for two different statistical purposes: 316 cases were used to adjust the logistic regression models to predict each characteristic of post-endodontic pain using predictive factors, and the remaining 58 cases were used to test the validity of each model. RESULTS The predictive models showed that the incidence of post-endodontic pain was significantly lower when the treated tooth was not a molar (P = 0.003), demonstrated periapical radiolucencies (P = 0.003), had no history of previous pain (P = 0.006) or emergency endodontic treatment (P = 0.045) and had no occlusal contact (P < 0.0001). The probability of experiencing moderate or severe pain was higher with increasing age (P = 0.09) and in mandibular teeth (P = 0.045). The probability of pain lasting more than 2 days was increased with age (P = 0.1) and decreased in males (P = 0.007) and when a radiolucent lesion was present on radiographs (P = 0.1). CONCLUSIONS Predictive formulae for the incidence, the intensity and the duration of post-endodontic pain were generated and validated taking account of the interrelation of multiple concomitant clinical factors. A predictive model for triggering post-endodontic pain could not be established.
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A prospective clinical trial on the influence of a triamcinolone/demeclocycline and a calcium hydroxide based temporary cement on pain perception.
Willershausen, B, Willershausen, I, Ehlers, V, Azaripour, A, Briseño, B
Head & face medicine. 2012;:9
Abstract
INTRODUCTION The aim of this clinical trial was to compare the degree of short term post-operative irritation after application of a triamcinolone/demeclocycyline based or a calcium hydroxide based provisional cement. METHODS A total of 109 patients (55 female and 54 male; mean age: 51 ± 14 years) with primary or secondary dentinal caries were randomly assigned to the two treatment groups of this biomedical clinical trial (phase III). Selection criteria were good systemic health and treated teeth, which were vital and showed no symptoms of pulpitis. Up to three teeth were prepared for indirect metallic restorations, and the provisional restorations were cemented with a triamcinolone/demeclocycyline (Ledermix) or a calcium hydroxide (Provicol) based material. The intensity of post-operative pain experienced was documented according to the VAS (4, 12, 20, 24, and 82 h) and compared to VAS baseline. RESULTS A total of 159 teeth were treated (Ledermix: 83 teeth, Provicol: 76 teeth). The minor irritation of the teeth, experienced prior to treatment, was similar in both groups; however, 4 h after treatment this value was significantly higher in the Provicol group than in the Ledermix group (p < 0.005, t-test). After 12 h, the difference was no longer significant. The number of patients taking analgesics for post-treatment pain was higher in the Provicol group (n = 11/53) than in the Ledermix group (n = 3/56). CONCLUSIONS The patients had no long term post-operative pain experience in both groups. However, within the first hours after cementation the sensation of pain was considerably higher in the Provicol group than in the Ledermix group.
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Clinical efficacy of a novel new injectable diclofenac formulation designed for intradeltoid use in post-operative pain management.
Shah, P, Subnis, B, Varshney, A, Pradhan, C, Murthy, TV, Shah, D, Jaiswal, V
International journal of clinical pharmacology and therapeutics. 2011;(4):286-90
Abstract
OBJECTIVE A randomized study comparing efficacy and safety of a new 75 mg/1 ml formulation of injectable diclofenac sodium designed for intra-deltoid use with the conventional 75 mg/3 ml formulation given by the intra-gluteal route. DESIGN This was an open-label, multicentric, randomized clinical trial. METHODS A total of 250 adult patients with post-operative pain were randomized to receive either an injection diclofenac 75 mg/1 ml or diclofenac 75 mg/3 ml. Primary efficacy criteria were time to onset of analgesia and reduction in pain intensity. Severity of pain at site of injection and side effects were also evaluated. RESULTS 232 patients completed the study. The mean times to onset of anal-gesia were comparable (16.17 ± 12.70 min in the diclofenac 75 mg/1 ml group and 19.16 ± 11.79 min in the diclofenac 75 mg/3 ml group). However, significantly more patients achieved analgesia in less than 5 min and had less pain at the site of injection with the 1 ml formulation. The need for rescue medication was also lower with the 1 ml formulation (2.5% vs. 9.82%). No side effects were reported. A significantly larger number of patients and physicians rated the efficacy and safety of injectable diclo-fenac 75 mg/1 ml as excellent. CONCLUSION Both formulations were effective and safe in the management of post-operative pain with a significantly lower need for rescue analgesia and less pain at site of injection with diclofenac 75 mg/1 ml formulation. The 1 ml formulation had an added advantage of intra-deltoid use. This would be specially helpful in obese/overweight patients with a thick subcutaneous pad of fat over the gluteal region.
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Efficacy and safety of oxycodone HCl/niacin tablets for the treatment of moderate-to-severe postoperative pain following bunionectomy surgery.
Daniels, SE, Spivey, RJ, Singla, S, Golf, M, Clark, FJ
Current medical research and opinion. 2011;(3):593-603
Abstract
OBJECTIVE To evaluate the efficacy and safety of two dose strengths of oxycodone hydrochloride (HCl)/niacin tablets * for the treatment of moderate-to-severe postoperative pain following bunionectomy surgery. RESEARCH DESIGN AND METHODS Randomized, double-blind, placebo-controlled, US multicenter, repeat-dose study (Clinicaltrials.gov: NCT00654069). A total of 606 patients aged ≥18 years with moderate-to-severe pain post-bunionectomy were screened, and 405 patients were randomized to receive placebo, 2 × 5/30 mg oxycodone HCl/niacin tablets, or 2 × 7.5/30 mg oxycodone HCl/niacin tablets administered every 6 hours for 48 hours. Ketorolac tromethamine was available as rescue medication. MAIN OUTCOME MEASURES Primary efficacy endpoint was the sum of pain-intensity difference scores during the 48 hours (SPID(48)) following the initial dose of study drug. Secondary efficacy endpoints included a responder analysis and use of rescue medication. Safety evaluations included adverse events (AEs), vital signs, and clinical laboratory assessments. RESULTS Both doses of oxycodone HCl/niacin tablets demonstrated superior reductions in pain intensity compared with placebo as evidenced by the SPID(48) (p < 0.0001 for both oxycodone HCl/niacin 2 × 5/30 mg and 2 × 7.5/30 mg). AEs were consistent with the known effects of oxycodone HCl and niacin. Most AEs were mild or moderate in intensity, and no serious AEs occurred. There were no discontinuations due to AEs in the placebo group; 2/135 (1.5%) discontinued due to AEs in the 2 × 5/30 mg group and 4/134 (3.0%) in the 2 × 7.5/30 mg group. A limitation of this study was that there was no active comparator arm. CONCLUSIONS Oxycodone HCl/niacin tablets (5/30 mg and 7.5/30 mg) provide effective analgesia and are generally well tolerated in patients with moderate-to-severe pain following bunionectomy surgery.