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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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Tolerability and toxicity of topically applied nepafenac 0.3% compared with generic ketorolac 0.5.
Hovanesian, J, Holland, E
Journal of cataract and refractive surgery. 2019;(2):174-180
Abstract
PURPOSE To compare patient-reported tolerability, impact on quality of life, interference with activities of daily life, and ocular surface toxicity of branded nepafenac 0.3% and generic ketorolac 0.5% after cataract surgery. SETTING Harvard Eye Associates, Laguna Hills, California, and the Cincinnati Eye Institute, Ohio, USA. DESIGN Prospective case series. METHODS One eye of each patient was randomized to receive ketorolac 0.5% or nepafenac 0.3% topical eyedrops for 3 days preoperatively and 28 days postoperatively. Additional medications were moxifloxacin 0.5% 4 times a day 3 days preoperatively and 7 days postoperatively and difluprednate 0.05% twice a day for 1 week postoperatively. Primary endpoints were patient-reported tolerability of each drug, the related impact on quality of life, and activities of daily life. Secondary endpoints were differences in conjunctival hyperemia, anterior chamber inflammation, tear breakup time (TBUT), and corneal staining. RESULTS Baseline characteristics were similar between the nepafenac group (n = 91) and the ketorolac group (n = 90). Burning and stinging lasted longer in the ketorolac group, while blurry/hazy/foggy vision and a film or coating on the eye lasted longer in the nepafenac group (all P < .0001). All objective measures were statistically significant for ketorolac 0.5% versus nepafenac 0.3% as follows: corneal staining (64% versus 28%); Oxford grade 2 or greater staining (28% versus 4%); Schulze grade 30 or greater conjunctival erythema (65% versus 36%, respectively); abnormal TBUT greater than 10 seconds (77% versus 51%) (all P < .0001). CONCLUSION Branded nepafenac 0.3%-treated patients had significantly better objective and subjective outcomes after cataract surgery than generic ketorolac 0.5%-treated patients.
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Dose-response of intrathecal morphine when administered with intravenous ketorolac for post-cesarean analgesia: a two-center, prospective, randomized, blinded trial.
Berger, JS, Gonzalez, A, Hopkins, A, Alshaeri, T, Jeon, D, Wang, S, Amdur, RL, Smiley, R
International journal of obstetric anesthesia. 2016;:3-11
Abstract
BACKGROUND The appropriate dose of intrathecal morphine for post-cesarean analgesia is unclear. With the inclusion of routine non-steroidal anti-inflammatory drugs, the required dose of morphine may be significantly less than the 200-300μg common a decade ago. We performed a two-center, prospective, randomized, blinded trial comparing three doses of intrathecal morphine, combined with routine intravenous ketorolac, in 144 healthy women undergoing elective cesarean delivery. METHODS Patients received an intrathecal injection of hyperbaric bupivacaine 12mg, fentanyl 15μg and a randomized dose of 50, 100, or 150μg morphine in a volume of 2.2mL. Patients received intravenous ketorolac 30mg before leaving the operating room and 15mg intravenously every 6h for the duration of the study (24h). All received postoperative patient-controlled intravenous morphine. The primary endpoint was total intravenous morphine administered postoperatively over 24h, analyzed using mixed model regression. RESULTS There were no differences between dose groups (or institutions) in intravenous morphine use over 24h. Visual analog scale scores for pain and nausea did not differ. Pruritus was greater in the 100 and 150μg groups than the 50μg group at 6h and 12h, but there was no difference between groups in nausea or pruritus treatments. Respiratory depression or significant sedation did not occur. CONCLUSION The dose-response relationship of intrathecal morphine for multimodal post-cesarean analgesia suggests that 50μg produces analgesia similar to that produced by either 100μg or 150μg.
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TREATMENT OF EXUDATIVE AGE-RELATED MACULAR DEGENERATION WITH RANIBIZUMAB COMBINED WITH KETOROLAC EYEDROPS OR PHOTODYNAMIC THERAPY.
Semeraro, F, Russo, A, Delcassi, L, Romano, MR, Rinaldi, M, Chiosi, F, Costagliola, C
Retina (Philadelphia, Pa.). 2015;(8):1547-54
Abstract
PURPOSE To evaluate whether ketorolac eyedrops plus intravitreal ranibizumab (IVR) or verteporfin photodynamic therapy plus IVR provides additional benefit over IVR monotherapy for treatment of choroidal neovascularization in age-related macular degeneration. METHODS This was a prospective, randomized, pilot study in 75 patients with naive choroidal neovascularization. Patients were randomized 1:1:1 into 3 groups: ranibizumab monotherapy (RM), ranibizumab plus ketorolac, or ranibizumab plus loading-phase reduced-fluence verteporfin photodynamic therapy (RV) groups. RESULTS At 12 months, all groups showed significant improvement in both best-corrected visual acuity and central retinal thickness. The mean best-corrected visual acuity change from baseline to 12 months was -0.14 ± 0.52 logMAR (20/73 ± 20/29), -0.25 ± 0.60 logMAR (20/46 ± 20/27), and -0.10 ± 0.30 (20/97 ± 20/40) logMAR in RM, ranibizumab plus ketorolac, and RV groups, respectively. The mean central retinal thickness change from baseline to 12 months was -125 ± 15 μm, -141 ± 21 μm, and -130 ± 15 μm in RM, ranibizumab plus ketorolac, and RV groups, respectively. Both ranibizumab plus ketorolac and RV groups required fewer IVR treatments than RM. CONCLUSION Compared with RM and ranibizumab plus verteporfin photodynamic therapy, the combination of 0.45% ketorolac eyedrops 3 times a day and ranibizumab in patients with choroidal neovascularization provided superior best-corrected visual acuity and central retinal thickness outcomes. Both combination regimens required fewer IVR injections than RM during the 12-month follow-up period.
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Comparative evaluation of olopatadine 0.01% combined fluorometholone 0.1% treatment versus olopatadine 0.01% combined ketorolac 0.4% treatment in patients with acute seasonal allergic conjunctivitis.
Celik, T, Turkoglu, EB
Current eye research. 2014;(1):42-6
Abstract
PURPOSE To evaluate the therapeutic effects of low-effective steroid fluorometholone 0.1% and non-steroidal anti-inflammatory ketorolac 0.4% when concomitantly used with olopatadine 0.01% in relieving clinical signs and symptoms of acute seasonal allergic conjunctivitis (SAC). METHODS In this randomized, placebo-controlled, multi-center study, 104 eyes of 52 patients with the diagnosis of SAC were conducted. The patients were assigned into two groups to receive either olopatadine and fluorometholone one eye and placebo in the contralateral eye or olopatadine and ketorolac one eye and placebo in the contralateral. The clinical signs (chemosis, mucus secretion, eyelid edema) and symptoms (itching, redness, tearing, burning) of the patients were evaluated by summing up the scores using a 3-point scale. Results were analyzed by Mann-Whitney U test, p values less than 0.05 were defined as significant. RESULTS All parameters were improved less amount on the first day of the treatment in both groups, however, significant reduction in clinical signs and symptoms were seen on the 10th day compared with those receiving placebo. Fluorometholone was found superior to ketorolac in reducing redness, mucus secretion, chemosis and eyelid edema (p = 0.032 for redness, p = 0.028 for mucus secretion, p = 0.030 for chemosis, p = 0.042 for eyelid edema) and both drugs were similar in alleviating the symptoms itching, burning and tearing (p = 0.074 for itching, p = 0.064 for burning, p = 0.072 for tearing). CONCLUSIONS Fluorometholone was better than ketorolac in relieving redness, chemosis, mucus secretion and eyelid edema when concomitantly used with olopatadine, however, these two drugs were found equal in attenuating the symptoms itching, burning and tearing.
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Analgesic efficacy and safety of a novel injectable formulation of diclofenac compared with intravenous ketorolac and placebo after orthopedic surgery: a multicenter, randomized, double-blinded, multiple-dose trial.
Daniels, S, Melson, T, Hamilton, DA, Lang, E, Carr, DB
The Clinical journal of pain. 2013;(8):655-63
Abstract
OBJECTIVES A novel injectable formulation of diclofenac, Dyloject, utilizes hydroxypropyl-β-cyclodextrin (HPβCD) as a solubilizing agent, allowing dosing as a small-volume intravenous bolus for postoperative pain. In this test of the efficacy and safety of HPβCD diclofenac, we hypothesized that HPβCD diclofenac would relieve moderate and severe pain after orthopedic surgery. PATIENTS AND METHODS Adults 18 to 85 years old with moderate and severe pain within 6 hours after surgery were randomized to HPβCD diclofenac, ketorolac tromethamine, or placebo, and stratified by risk cohort. The HPβCD diclofenac non-high-risk cohort dose was 37.5 mg, the high-risk cohort received 18.75 mg, and patients ≥95 kg received 50 mg. The ketorolac dose was 30 mg in the non-high-risk and high-weight cohorts and 15 mg in the high-risk cohort. Rescue intravenous morphine was given for pain as needed. Efficacy was measured by the sum of pain intensity differences (SPID). RESULTS Mean SPID scores of 277 patients were significantly better with HPβCD diclofenac and ketorolac than with placebo (P<0.0001), across all risk cohorts (P<0.05). HPβCD diclofenac was associated with better SPID scores, faster onset of analgesia, and significantly lower opioid requirement (P<0.008) than ketorolac. In patients more than or equal to 65 years, HPβCD diclofenac was associated with significantly better analgesic efficacy (P=0.05), and lower opioid requirement versus ketorolac. The incidence of treatment-related adverse events was similar across groups. DISCUSSION HPβCD diclofenac is safe and efficacious for acute moderate and severe pain after orthopedic surgery and significantly spares morphine use.
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A novel drug eluting ureteral stent: a prospective, randomized, multicenter clinical trial to evaluate the safety and effectiveness of a ketorolac loaded ureteral stent.
Krambeck, AE, Walsh, RS, Denstedt, JD, Preminger, GM, Li, J, Evans, JC, Lingeman, JE, ,
The Journal of urology. 2010;(3):1037-42
Abstract
PURPOSE We evaluated the short-term safety and efficacy of a ketorolac loaded ureteral stent compared to a standard stent (control). MATERIALS AND METHODS In this prospective, multicenter, double-blind study patients were randomized 1:1 to ketorolac loaded or control stents after ureteroscopy. The primary end point was an intervention for pain defined as unscheduled physician contact, change in pain medication or early stent removal. Secondary end points included medication use and pain visual analog score. A total of 20 patients underwent serum safety testing for ketorolac levels. RESULTS None of the safety cohort had detectable serum ketorolac levels. Among the 276 patients there was no difference in primary (9.0% ketorolac loaded vs 7.0% control, p = 0.66) or secondary (22.6% ketorolac loaded vs 25.2% control, p = 0.67) intervention rates. Mean pain pill count at day 3 was lower in the ketorolac loaded stent group than in the control group (p <0.05). A higher number (p = 0.057) of patients with ketorolac loaded (32%) stents used no or limited pain medications compared to controls (22%). A higher number of male patients with ketorolac loaded stents used no pain medication on days 3 and 4 compared to female patients with ketorolac loaded stents, and male and female control patients (p <0.05). CONCLUSIONS The overall safety of the ketorolac loaded stent was confirmed. Although there was no significant difference in primary or secondary intervention rates, a trend toward a treatment benefit was noted for patients receiving drug loaded stents. Specifically young male patients appeared to require less pain medication when the ketorolac loaded stent was used. Future studies with higher drug concentrations or alternative drug eluting stents may prove beneficial.
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Paracervical block with combined ketorolac and lidocaine in first-trimester surgical abortion: a randomized controlled trial.
Cansino, C, Edelman, A, Burke, A, Jamshidi, R
Obstetrics and gynecology. 2009;(6):1220-1226
Abstract
OBJECTIVE To study the effects of a paracervical block with combined ketorolac and lidocaine on perceived pain during first-trimester surgical abortion. METHODS A double-masked, placebo-controlled, randomized clinical trial of 50 women undergoing first-trimester surgical abortions (before 11 weeks of gestation) received either oral ibuprofen with a lidocaine-alone paracervical block or an oral placebo and paracervical block with combined ketorolac and lidocaine. Women completed a series of 100-mm visual analog scales (anchors: 0=none, 100 mm=worst imaginable) to measure their perceived pain (anticipated pain, pain during and after surgical abortion, and total satisfaction). RESULTS Twenty-five women received preoperative oral ibuprofen followed by paracervical block with lidocaine alone, and 25 received oral placebo followed by paracervical block with combined ketorolac and lidocaine. Groups were similar with respect to sociodemographic variables. Women who received paracervical block with combined ketorolac and lidocaine reported significantly less pain after cervical dilation (59.8 compared with 74.8 mm, P<.05). The groups did not differ in perceived procedure-related or postoperative pain. There was no difference in overall satisfaction with pain control between the two groups (63.6 compared with 62.9 mm, P=.93). CONCLUSION Paracervical block with combined ketorolac and lidocaine significantly decreases perceived pain associated with cervical dilation during first-trimester surgical abortion. This analgesic mixture may be offered as an alternative pain regimen to women seeking first-trimester surgical abortion. It may also offer improved pain control in other gynecologic procedures necessitating cervical dilation. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, www.clinicaltrials.gov, NCT00617097. LEVEL OF EVIDENCE I.
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Double-masked study of the effects of nepafenac 0.1% and ketorolac 0.4% on corneal epithelial wound healing and pain after photorefractive keratectomy.
Donnenfeld, ED, Holland, EJ, Durrie, DS, Raizman, MB
Advances in therapy. 2007;(4):852-62
Abstract
Two NSAIDs--nepafenac 0.1% and ketorolac tromethamine 0.4%-were compared in terms of their effects on corneal reepithelialization and pain after photorefractive keratectomy (PRK) in a randomized, double-masked, contralateral eye, multicenter study. A total of 40 healthy adult patients who were undergoing sequential bilateral PRK received nepafenac 0.1% and ketorolac 0.4% in contralateral eyes, 1 drop 3 times daily for 3 d after bandage contact lens insertion. Patients were assessed on postoperative days 1, 3, 4, 5, and 7. At each visit, patients provided a general rating of pain. Each patient also assessed the sensation of each eyedrop following instillation (after-drop pain, irritation, burning/stinging, and overall comfort). Starting on day 3, epithelial defect size was assessed. Mean epithelial defect size was similar between treatments at each postoperative visit (P>.05). The average time-to-healing was 4.18 d for nepafenac 0.1% and 4.00 d for ketorolac 0.4% (P=.3134). No statistical difference was observed between nepafenac 0.1% and ketorolac 0.4% in mean postoperative pain scores (P>.05). On day 3, the nepafenac 0.1% group had significantly lower mean sensation scores than did the ketorolac 0.4% group for after-drop pain (P=.0090), irritation (P=.0007), and burning/ stinging (P=.0003). Mean overall comfort score was also significantly better for nepafenac 0.1% on day 3 (7.43 vs 6.41; P<.0001). Nepafenac 0.1% and ketorolac 0.4% provide postoperative pain relief after PRK surgery without associated adverse effects on corneal epithelial healing. Nepafenac 0.1% treatment may offer greater comfort upon instillation in patients who have undergone PRK.
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A double-blind, randomized study comparing postoperative pain management using epidural ropivacaine with intravenous ketorolac or intravenous ketorolac alone following transabdominal hysterectomy.
Chinachoti, T, Niruthisard, S, Tuntisirin, O, Thienthong, S, Khunsongkiet, P, Payawal, F, Camagay, I, De Castro, R
Journal of the Medical Association of Thailand = Chotmaihet thangphaet. 2002;:S837-47
Abstract
OBJECTIVE The aim of this study is to compare the effect on postoperative pain of epidural ropivacaine in combination with intravenous ketorolac with intravenous ketorolac alone following transabdominal hysterectomy. DESIGN A multi-center, randomized, double-blind study was conducted in Thailand and the Philippines to assess postoperative pain management in 107 patients given ketorolac alone or in combination with epidural ropivacaine following transabdominal hysterectomy. Pain score was assessed using a 100-mm visual analogue pain scale (VAS). RESULTS The VAS scores for pain on coughing and at rest were significantly better in the ropivacaine group. The number of patients who asked for morphine in addition was higher in the ketorolac group compared to the ropivacaine + ketorolac group. The time taken to carry out the first three ambulatory steps was similar for both the two treatment groups. A higher degree of motor block was observed in the ropivacaine group over time. The adverse events observed were similar in both groups. CONCLUSION We demonstrated that epidural infusion of ropivacaine in addition with intravenous ketorolac gave superior pain relief at rest and on coughing in patients undergoing transabdominal hysterectomy when compared to the group receiving intravenous ketorolac alone.