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Analgesic efficacy of ketorolac associated with a tramadol/acetaminophen combination after third molar surgery - a randomized, triple-blind clinical trial.
Martins, LD, Rezende, M, Loguercio, AD, Bortoluzzi, MC, Reis, A
Medicina oral, patologia oral y cirugia bucal. 2019;(1):e96-e102
Abstract
BACKGROUND This study compared the efficacy of ketorolac alone versus its combination with tramadol/acetaminophen for pain control after mandibular third molar surgery. MATERIAL AND METHODS A randomized, triple-blind clinical trial was carried out with 52 patients divided into 2 groups: Group K+T+A (1 tablet of Ketorolac 10 mg plus and 1 capsule of Tramadol 37.5 mg/acetaminophen 325 mg) and Group K (1 tablet of Ketorolac 10 mg plus and 1 placebo capsule). The treatments were given 1 h before the surgery and was repeated 4 times per day, for 48 h. The difference in postoperative pain was assessed by 4 primary end-points: pain intensity (VAS 100mm, for 48 h), rescue medication, overall assessment and adverse effects. RESULTS Significant differences in pain intensity were observed in the different times (p < 0.05). The comparison of groups in each time showed significant differences only of 9 h, with lower level of pain intensity for group K+T+A (p = 0.005). The need of analgesics was higher in Group K (p < 0.001), the need of antiemetic were greater in Group K+T+A (p < 0.0001). No significant difference between groups were observed in overall assessment. The adverse effects was higher in Group K+T+A. CONCLUSIONS The current study showed that both ketorolac and the combination of ketorolac plus tramadol/acetaminophen showed good control of pain after the extraction of the lower third molars. Although the combination group showed lower pain at 9 h, the difference is small and not clinically relevant.
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Perioperative Ketorolac for Supracondylar Humerus Fracture in Children Decreases Postoperative Pain, Opioid Usage, Hospitalization Cost, and Length-of-Stay.
Adams, AJ, Buczek, MJ, Flynn, JM, Shah, AS
Journal of pediatric orthopedics. 2019;(6):e447-e451
Abstract
BACKGROUND There is a need for improved opioid stewardship in orthopedic surgery through multimodal analgesia strategies. Perioperative administration of ketorolac in children undergoing closed reduction and percutaneous pinning (CRPP) for displaced supracondylar humerus (SCH) fracture may decrease pain, reduce opioid requirements, and decrease hospitalization costs. METHODS Retrospective case-control investigation of children (aged, 1 to 14) treated with CRPP for closed, modified Gartland type III extension-type SCH fractures at a single children's hospital between 2011 and 2017. Patients that received ketorolac perioperatively (cases) were randomly matched 1:2 by sex and age (±1 y) with patients that did not receive ketorolac (controls). Data abstraction included demographic and perioperative details including inpatient Wong-Baker FACES pain ratings and analgesic requirements. Analysis included 2-tailed Mann-Whitney U and χ tests. RESULTS In total, 342 patients were studied including 114 cases and 228 controls. Age (mean, 6.2±2.4 y), sex ratio (M:F, 1.28:1), operative time, and number of pins used were equivalent between groups. Mean pain rating at 0 to 29 minutes postoperatively was lower in the ketorolac group (0.7±1.9) than in controls (1.4±2.6, P=0.017), as well as at 30 to 120 minutes postoperatively (1.1±2.3 and 1.7±2.8, respectively, P=0.036), as seen in Figure 1. Patients in the ketorolac group received a lower number of inpatient oxycodone doses (1.0±0.6) than control patients (1.2±0.5, P=0.003). Mean postoperative length-of-stay (LOS) was 50.0% longer for control patients (20.4±11.3 h) than the ketorolac patients (13.6±8.8 h, P<0.001). Ketorolac administration was associated with 40.4% lower inpatient hospitalization cost compared to control patients, providing a 33.8 times return on investment. There was no difference in the 90-day complication rate between patient groups (P=0.905). CONCLUSIONS The complementary administration of ketorolac reduces postoperative pain and opioid use in children with displaced supracondylar humerus fractures. Perioperative ketorolac is also associated with reduced LOS following CRPP for supracondylar humerus fractures and offers significant cost savings opportunities. LEVEL OF EVIDENCE Level 3-Therapeutic: Case-Control Study.
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Administering analgesia sublingually is a suitable option for children with acute abdominal pain in the emergency department.
Cozzi, G, Zanchi, C, Chiaretti, A, Tipo, V, Cernich, M, D'Anna, C, Fantacci, C, Conversano, E, Zanon, D, Ronfani, L, et al
Acta paediatrica (Oslo, Norway : 1992). 2019;(1):143-148
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Abstract
AIM: Acute abdominal pain is a frequent complaint in children attending emergency departments. The aim of this study was to investigate the pain score reductions when children with acute abdominal pain received medication sublingually. METHODS We carried out a multicentre randomised controlled trial in three children's hospitals in Italy between March 2015 and June 2017. Children from four to 18 years of age with acute abdominal pain were recruited if their self-reported pain was at least six on a scale from 0-10. The children were randomised to receive ketorolac 0.5 mg/kg (n = 70) or tramadol 2 mg/kg (n = 70) sublingually or a melt in the mouth powder of 20 mg/kg paracetamol (n = 70). The main study outcome was the pain scores for the three drugs after two hours. RESULTS The 210 children (58.6% girls) had a median age of 12 years with an interquartile range of 9-14.3. The median pain scores at two hours were not significantly different between ketorolac 2.0 (interquartile ranges, IQR 0.0-4.3) and tramadol 3.0 (IQR 1.0-5.0) vs paracetamol 3.0 (IQR 0.8-5.0). The median pain reductions were all 5.0 points. CONCLUSION Delivering analgesia sublingually was a suitable option for pain relief in children with acute abdominal pain in the emergency department.
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Preoperative Intravenous Ketorolac Safely Reduces Postoperative Pain in Levator Advancement Surgery.
Wladis, EJ, Dennett, KV, Chen, VH, De, A
Ophthalmic plastic and reconstructive surgery. 2019;(4):357-359
Abstract
PURPOSE To assess the impact of intravenous ketorolac (IVK) on self-reported pain scores, requirements for opioid analgesic and anti-emetic medications, and bleeding complications in the setting of levator advancement surgery METHODS A prospective randomized controlled trial was performed among adult patients undergoing levator advancement surgery. Pain scores were measured immediately after surgery, prior to discharge from the surgical facility, and on the first postoperative day. The requirements for postoperative analgesic and anti-emetic medications were recorded. Statistical comparisons were performed via a dedicated computerized software package. RESULTS Fifty patients (20 males, 30 females, mean age = 65.7 years, standard deviation = 11.9 years) underwent levator advancement without IVK and acted as controls. An additional 50 patients received IVK (19 males, 31 females, mean age = 64.6 years, standard deviation = 12.0 years). As compared with control patients, IVK resulted in statistically significant reductions in pain score immediately after surgery (4.62 vs. 1.44, p = 0.0001) and on postoperative day 1 (3.22 vs. 1.24, p = 0.0001). Fourteen patients (28%) in the control and 4 patients (8%) in the group that received IVK required opioid analgesics (p = 0.017). Seven patients (14%) in the control group and 1 patient in the group that received IVK required anti-emetic medications (p = 0.059). No patient experienced a hemorrhagic complication. CONCLUSIONS In the setting of levator advancement surgery, IVK results in a dramatic reduction in self-reported pain score immediately after surgery and on postoperative day 1 and the requirement for opioid analgesics. This medication may be safely utilized for ptosis repair.
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Prospective, double-blind, randomized clinical trial comparing an ERAS pathway with ketorolac and pregabalin versus standard of care plus placebo during live donor nephrectomy for kidney transplant.
Campsen, J, Call, T, Allen, CM, Presson, AP, Martinez, E, Rofaiel, G, Kim, RD
American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons. 2019;(6):1777-1781
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Abstract
Opioid exposure is a concern after live donation for kidney transplant. We theorized that an enhanced recovery after surgery pathway (ERAS) using pregabalin preoperatively to desensitize nerves followed by the nonsteroidal anti-inflammatory drug ketorolac, during and after surgery, can control pain, thus requiring less perioperative narcotics. The aim of this study was to determine if the use of a nonopioid analgesic ERAS protocol for donor nephrectomies could decrease the use of narcotics without an increase in complications compared with standard of care (SOC). This is a single-center, prospective, double-blind, randomized clinical trial involving a total of 62 patients undergoing nephrectomy for live donor kidney transplant. Length of hospital stay (LOS) was significantly reduced by 10% in the ERAS group versus the SOC-plus-placebo group. Morphine dose equivalents were significantly reduced by 40% in the study group versus the SOC-plus-placebo group. The use of this nonopioid analgesic ERAS pathway for donor nephrectomies decreased the use of narcotics without an increase in complications compared with SOC. There was significantly reduced LOS and less narcotic use in the study group versus the SOC-plus-placebo group. (ClinicalTrials.gov registration number: NCT03669081).
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A prospective randomized trial of intravenous ketorolac vs. acetaminophen administered with opioid patient-controlled analgesia in gynecologic surgery.
Rakowski, JA, Holloway, RW, Ahmad, S, Jeppson, CN, James, JA, Ghurani, GB, Bigsby, GE, Kendrick, JE
Gynecologic oncology. 2019;(3):468-472
Abstract
OBJECTIVE To determine which non-narcotic analgesic, acetaminophen (Ofirmev®) or ketorolac (Toradol®), provides better post-operative pain control when combined with an opioid patient-controlled analgesia (PCA) pump. Secondary objectives include comparisons of the rates of ileus, post-operative bleeding, transfusions, and length-of-hospitalization (LOH). METHODS A prospective, randomized trial of acetaminophen (A) 1-g intravenous (IV) every 6-h or ketorolac (K) 15-mg IV every 6-h from post-operative day 1-3 in addition to an opioid PCA for patients undergoing benign or malignant gynecologic laparotomy procedures was performed. Abstracted data included pain levels via visual analogue pain scales (VAS), amount of narcotic used, hepatic enzyme levels, hemoglobin, urine output, blood transfusions, time to return of flatus and LOH. RESULTS One-hundred patients were accrued and underwent 55 benign gynecologic laparotomies and 45 cancer-related laparotomies. VAS pain levels (3.3 K, 3.5 A) and morphine PCA use (79.1 oral morphine equivalents [OME] K vs. 84.5 A) were not different, however dilaudid PCA usage was less by K patients (84.4 OME K and 136.8 OME A, p < 0.001). There was a significant hemoglobin change between the two groups (2.6 g K vs. 2 g A, p = 0.015), however blood transfusions were equal (28% K, 22% A, p > 0.05). Return of flatus was 2.7-days for K vs. 3.4-days for A (p = 0.011) and LOH was not different (4.4-days K vs. 5.1-days A, p = 0.094). CONCLUSIONS Both intravenous ketorolac and acetaminophen provide similar post-operative analgesia through VAS pain scales and total usage of morphine via PCA pumps. Use of ketorolac with dilaudid PCA was associated with less dependence on dilaudid and a quicker return of bowel function than acetaminophen, however length of stay and transfusion rates were not different.
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Efficacy of pethidine, ketorolac, and lidocaine gel as analgesics for pain control in shockwave lithotripsy: A single-blinded randomized controlled trial.
Hashem, A, Ghobrial, FK, Elbaset, MA, Atwa, AM, Fadallah, M, Laymon, M, El-Assmy, A, Sheir, KZ, Abol-Enein, H
Investigative and clinical urology. 2019;(4):251-257
Abstract
PURPOSE To compare the safety and efficacy of xylocaine gel and ketorolac as opioid-sparing analgesia compared with pethidine for shock wave lithotripsy (SWL) pain. MATERIALS AND METHODS A single-blinded randomized controlled trial (RCT) was performed in 132 patients with renal and upper ureteral stones amenable to treatment with SWL. The first patient group received intravenous (IV) pethidine and placebo gel; the second group received IV ketorolac plus placebo gel; the third group received lidocaine gel locally plus normal saline IV. Stone disintegration was classified as none (no change from basal by kidney, ureter, bladder X-ray or ultrasound [US] imaging), partial (fragmented and >4-mm residual fragments), and complete (≤4-mm residual fragments). Stone disintegration was assessed by kidney-ureter-bladder X-ray and US imaging. Pain was evaluated by use of the Numeric Pain Rating Scale (NPRS). RESULTS The NPRS scores were highest in the xylocaine group at 10, 20, and 30 minutes (p=0.0001) with no significant difference between the ketorolac and pethidine groups, except at 10 minutes (p=0.03) and a near significant difference at 30 minutes (p=0.054) in favor of ketorolac. Results for stone disintegration (none, partial, and complete, respectively) were as follows: 25 (50.0%), 23 (46.0%), and 2 (4.0%) for pethidine; 19 (35.8%), 23 (43.4%), and 11 (20.8%) for ketorolac; and 26 (89.7%), 3 (10.3%), and 0 (0.0%) for lidocaine (p=0.008). CONCLUSIONS Ketorolac is a safe and more effective alternative to morphine derivatives for SWL analgesia. Lidocaine gel should not be used as mono-analgesia for SWL.
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Comparison Between Diclofenac and Ketorolac Ophthalmic Drops for Pain Management After Photorefractive Keratectomy: A Randomized Clinical Study.
Mohammadpour, M, Heidari, Z, Molani, R
Eye & contact lens. 2019;(2):137-140
Abstract
OBJECTIVES To assess and compare the efficacy of two nonsteroidal anti-inflammatory drugs (NSAIDs), namely diclofenac and ketorolac, for pain control after photorefractive keratectomy (PRK). METHODS In this double-masked clinical study, 60 patients treated bilaterally with PRK were randomly allocated into two groups. Postoperatively, one group of patients received diclofenac 0.1% drops and the other group was prescribed ketorolac 0.5% ophthalmic drops in both eyes every 6 hr on the first day and then, no NSAID was applied until the third day. No oral analgesic drug was used after surgery. Patients completed the Visual Analog Scale questionnaire to determine the degree of pain and ocular discomfort (tearing, foreign body sensation, blurred vision, and photophobia) on the first and the third day after surgery. RESULTS Pain relief was achieved with both medications after surgery, and there was no significant intergroup difference in the level of pain reduction at 24 and 72 hr postoperatively (P>0.05). The ketorolac group experienced less tearing and photophobia only at 24 hr postoperatively (P=0.01), and by 72 hr after surgery, the results were similar in two groups (P>0.05). There was no significant intergroup difference in terms of foreign body sensation or blurred vision on the first or third postoperative days (P>0.05). CONCLUSIONS Both diclofenac and ketorolac are effective in reducing pain and ocular discomfort after PRK, and ketorolac may have greater control on tearing and photophobia during the first 24 postoperative hours.
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Intraoperative ketorolac in high-risk breast cancer patients. A prospective, randomized, placebo-controlled clinical trial.
Forget, P, Bouche, G, Duhoux, FP, Coulie, PG, Decloedt, J, Dekleermaker, A, Guillaume, JE, Ledent, M, Machiels, JP, Mustin, V, et al
PloS one. 2019;(12):e0225748
Abstract
BACKGROUND Ketorolac has been associated with a lower risk of recurrence in retrospective studies, especially in patients with positive inflammatory markers. It is still unknown whether a single dose of pre-incisional ketorolac can prolong recurrence-free survival. METHODS The KBC trial is a multicenter, placebo-controlled, randomized phase III trial in high-risk breast cancer patients powered for 33% reduction in recurrence rate (from 60 to 40%). Patients received one dose of ketorolac tromethamine or a placebo before surgery. Eligible patients were breast cancer patients, planned for curative surgery, and with a Neutrophil-to-Lymphocyte Ratio≥4, node-positive disease or a triple-negative phenotype. The primary endpoint was Disease-Free Survival (DFS) at two years. Secondary endpoints included safety, pain assessment and overall survival. FINDINGS Between February 2013 and July 2015, 203 patients were assigned to ketorolac (n = 96) or placebo (n = 107). Baseline characteristics were similar between arms. Patients had a mean age of 55.7 (SD14) years. At two years, 83.1% of the patients were alive and disease free in the ketorolac vs. 89.7% in the placebo arm (HR: 1.23; 95%CI: 0.65-2.31) and, respectively, 96.8% vs. 98.1% were alive (HR: 1.09; 95%CI: 0.34-3.51). CONCLUSIONS A single administration of 30 mg of ketorolac tromethamine before surgery does not increase disease-free survival in high risk breast cancer patients. Overall survival difference between ketorolac tromethamine group and placebo group was not statistically significant. The study was however underpowered because of lower recurrence rates than initially anticipated. No safety concerns were observed. TRIAL REGISTRATION ClinicalTrials.gov NCT01806259.
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Effectiveness of intravenous dexamethasone, metoclopramide, ketorolac, and chlorpromazine for pain relief and prevention of recurrence in the migraine headache: a prospective double-blind randomized clinical trial.
Khazaei, M, Hosseini Nejad Mir, N, Yadranji Aghdam, F, Taheri, M, Ghafouri-Fard, S
Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology. 2019;(5):1029-1033
Abstract
Dexamethasone, metoclopramide, ketorolac, and chlorpromazine have been used for the treatment of migraine headache. However, the effectiveness of these drugs in pain relief and prevention of recurrence and their side effects have not been compared yet. This was a randomized, double-blind clinical trial. Subjects were randomized to four groups; each received one of the following drugs intravenously: dexamethasone 8 mg, ketorolac 30 mg, metoclopramide 10 mg, and chlorpromazine 25 mg. The severity of headache in the two groups was assessed at starting point, 1 h and 24 h after the administration of drug using the visual analogue scale (VAS) on a scale of 0 to 10. No significant difference was found in the severity of symptoms between the four study groups before treatment, 1 h, and 24 h after treatment. The effect of all mentioned drugs on acute migraine headache was statistically significant at 1 and 24 h post-treatment compared to baseline. No significant difference was detected in the number of unresponsive cases between the four groups. There was a trend toward higher effectiveness of dexamethasone in prevention of recurrence (P = 0.05). Side effects were more common in chlorpromazine and less common in the dexamethasone-treated patients (P < 0.001). The present clinical trial shows the effectiveness of dexamethasone in prevention of recurrence and low frequency of treatment side effects.