-
1.
Comparing Ketorolac With Ibuprofen for Postoperative Pain: A Randomized Clinical Trial.
Dwarica, DS, Pickett, SD, Zhao, YD, Nihira, MA, Quiroz, LH
Female pelvic medicine & reconstructive surgery. 2020;(4):233-238
-
-
Free full text
-
Abstract
OBJECTIVES The objective of this study was to identify differences in pain perception and satisfaction with pain control in women receiving nonsteroidal anti-inflammatory drugs postoperatively. METHODS This was a prospective, randomized controlled trial including urogynecology surgical patients. After surgery, all patients were randomized to receive either intravenous (IV) ketorolac or ibuprofen. The patients completed 3 visual analog scales (VAS) assessing pain at rest, pain with ambulation, and satisfaction with pain control. Postoperative opioid use was also measured. RESULTS A total of 224 patients (112 in each arm) were included. Pain scores (SD) at rest in all patients who received ketorolac versus those who received ibuprofen was 2.30 (2.1) versus 2.68 (2.34) (P = 0.20). Pain scores (SD) with ambulation was 3.94 (2.57) versus 4.16 (2.73) (P = 0.57) in patients who received ketorolac and ibuprofen, respectively. Patients who received ketorolac rated their satisfaction with their pain regimen similarly to those who received ibuprofen (P = 0.50). The average amount (SD) of hydromorphone used in the ketorolac and ibuprofen arm was 3.68 (4.58) mg and 4.04 (4.97) mg, respectively (P = 0.58). A subgroup analysis based on type of surgery showed decreased pain at rest (VAS, 2.77 vs 4.88; P = 0.04) and increased satisfaction (VAS, 1.69 vs 4.67; P = 0.003) in patients who had laparotomy and received ketorolac. CONCLUSIONS There was no difference in pain and satisfaction with IV ketorolac compared with IV ibuprofen in patients who underwent all modalities of urogynecologic surgery. A subgroup of patients who underwent laparotomy had less pain with ketorolac.
-
2.
PDA-TOLERATE Trial: An Exploratory Randomized Controlled Trial of Treatment of Moderate-to-Large Patent Ductus Arteriosus at 1 Week of Age.
Clyman, RI, Liebowitz, M, Kaempf, J, Erdeve, O, Bulbul, A, Håkansson, S, Lindqvist, J, Farooqi, A, Katheria, A, Sauberan, J, et al
The Journal of pediatrics. 2019;:41-48.e6
-
-
Free full text
-
Abstract
OBJECTIVE To compare early routine pharmacologic treatment of moderate-to-large patent ductus arteriosus (PDA) at the end of week 1 with a conservative approach that requires prespecified respiratory and hemodynamic criteria before treatment can be given. STUDY DESIGN A total of 202 neonates of <28 weeks of gestation age (mean, 25.8 ± 1.1 weeks) with moderate-to-large PDA shunts were enrolled between age 6 and 14 days (mean, 8.1 ± 2.2 days) into an exploratory randomized controlled trial. RESULTS At enrollment, 49% of the patients were intubated and 48% required nasal ventilation or continuous positive airway pressure. There were no differences between the groups in either our primary outcome of ligation or presence of a PDA at discharge (early routine treatment [ERT], 32%; conservative treatment [CT], 39%) or any of our prespecified secondary outcomes of necrotizing enterocolitis (ERT, 16%; CT, 19%), bronchopulmonary dysplasia (BPD) (ERT, 49%; CT, 53%), BPD/death (ERT, 58%; CT, 57%), death (ERT,19%; CT, 10%), and weekly need for respiratory support. Fewer infants in the ERT group met the rescue criteria (ERT, 31%; CT, 62%). In secondary exploratory analyses, infants receiving ERT had significantly less need for inotropic support (ERT, 13%; CT, 25%). However, among infants who were ≥26 weeks gestational age, those receiving ERT took significantly longer to achieve enteral feeding of 120 mL/kg/day (median: ERT, 14 days [range, 4.5-19 days]; CT, 6 days [range, 3-14 days]), and had significantly higher incidences of late-onset non-coagulase-negative Staphylococcus bacteremia (ERT, 24%; CT,6%) and death (ERT, 16%; CT, 2%). CONCLUSIONS In preterm infants age <28 weeks with moderate-to-large PDAs who were receiving respiratory support after the first week, ERT did not reduce PDA ligations or the presence of a PDA at discharge and did not improve any of the prespecified secondary outcomes, but delayed full feeding and was associated with higher rates of late-onset sepsis and death in infants born at ≥26 weeks of gestation. TRIAL REGISTRATION ClinicalTrials.gov: NCT01958320.
-
3.
Pain Management After Surgical Tonsillectomy: Is There a Favorable Analgesic?
Jotić, A, Savić Vujović, K, Milovanović, J, Vujović, A, Radin, Z, Milić, N, Vučković, S, Medić, B, Prostran, M
Ear, nose, & throat journal. 2019;(6):356-361
-
-
Free full text
-
Abstract
The aim of this study was to examine how ibuprofen and paracetamol prevent pain after cold-steel extracapsular tonsillectomy in children. Also, we examined the relation between age, gender, nausea, postoperative bleeding, antibiotic use, type of diet, and postoperative pain intensity and the type of administered analgesic. A prospective study was conducted on 147 children (95 males and 52 females, aged 7-17 years) who underwent tonsillectomy in the Clinical-Hospital Center "Dragiša Mišović" from January 1 to June 30, 2016. The degree of pain was measured using a visual analog scale (VAS). We did not observe any significant differences in postoperative nausea, hospitalization rate postoperative bleeding, and antibiotic use between the paracetamol and ibuprofen groups. A test of within-patient effects showed that VAS scores changed significantly during the postoperative follow-up period (P = .00), but there were no significant differences between the groups (P = .778). After 12 hours, 29.3% of the patients on paracetamol and 21.8% on ibuprofen were transferred to a soft diet; after 24 hours, 84.8% of the paracetamol group and 85.5% of the ibuprofen group were on a soft diet (χ2 test, P < .05). There was a statistically significant correlation between VAS scores measured 4 hours after the surgery and the time of transference to the soft diet (Spearman ρ test, P < .001). The transfer to soft and normal diets was not significantly different between the 2 groups as assessed by the VAS scores (Pearson χ2 test, P = .565).There is still no consensus on the most effective postoperative pain-control regiment after tonsillectomy. This study showed that satisfactory pain management was achieved equally with both paracetamol and ibuprofen.
-
4.
Longer analgesic effect with naproxen sodium than ibuprofen in post-surgical dental pain: a randomized, double-blind, placebo-controlled, single-dose trial.
Cooper, SA, Desjardins, P, Brain, P, Paredes-Diaz, A, Troullos, E, Centofanti, R, An, B
Current medical research and opinion. 2019;(12):2149-2158
Abstract
Background: Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended as first-line medications in mild-to-moderate acute pain. However, comparative data regarding the duration of analgesia for commonly-used NSAIDs at non-prescription doses is lacking. This study evaluated the time to rescue medication following a single dose of naproxen sodium (NAPSO) vs ibuprofen (IBU) and placebo in subjects with moderate-to-severe post-surgical dental pain.Methods: This single-center, randomized, double-blind, parallel group, placebo-controlled study included healthy subjects with moderate-to-severe baseline pain (Categorical Pain Intensity Scale) who also rated their pain ≥ 5 on a 0-10 pain intensity Numerical Rating Scale following extraction of two impacted mandibular third molars. A single oral dose of NAPSO (440 mg), IBU (400 mg), or placebo was administered. The primary efficacy endpoint was the time to first rescue medication, while secondary endpoints included the sum of pain intensity difference (SPID) and total pain relief (TOTPAR) over 24 h. ClinicalTrials.gov trial registration number: NCT03404206 (EudraCT 2017-005049-67).Results: In the per protocol population (n = 385; mean age = 19 years), the time to rescue medication was significantly (p < .001) longer with NAPSO than IBU and placebo. After treatment, the greatest separation of NAPSO from IBU occurred at 9-14 h and from placebo at 1-6 h. Fewer NAPSO subjects required rescue medication (58/166, 34.9%) compared with IBU (137/165, 83.0%) and placebo (44/54, 81.5%). SPID 0-24 h and TOTPAR 0-24 h were both greater with NAPSO than IBU or placebo.Conclusions: The duration of pain relief after a single dose of NAPSO was significantly longer than after IBU, and significantly fewer NAPSO-treated subjects required rescue medication over a 24-h period.
-
5.
Efficacy and tolerability of a new ibuprofen 200mg plaster in patients with acute sports-related traumatic blunt soft tissue injury/contusion.
Predel, HG, Giannetti, B, Connolly, MP, Lewis, F, Bhatt, A
Postgraduate medicine. 2018;(1):24-31
Abstract
BACKGROUND Ibuprofen is used for the treatment of non-serious pain. This study assessed the efficacy and safety of a new ibuprofen plaster for the treatment of pain associated with acute sports impact injuries/contusions. METHODS In this randomised, double-blind, multi-centre, placebo controlled, parallel group study, adults (n = 130; 18-58 years of age) diagnosed with acute sports-related blunt soft tissue injury/contusion were randomized to receive either ibuprofen 200 mg plaster or placebo plaster. Plasters were administered once daily for five consecutive days. The primary assessment was area under the visual analogue scale (VAS) of pain on movement (POM) over 0 to three days (VAS AUC0-3d). Other endpoints included algometry AUC from 0 to three days (AUC0-3d) and 0 to five days (AUC0-5d), to evaluate improvement of sensitivity at the injured site, and patient and investigator global assessment of efficacy. Safety was monitored throughout the study. RESULTS The ibuprofen plaster resulted in superior reduction in AUC0-3d compared with placebo; the Least Squares (LS) mean difference was 662.82 mm*h in favour of the ibuprofen 200mg plaster (P = 0.0011). The greater improvement in VAS AUC of POM was also observed after 12 h, 24 h, and five days of therapy. Tenderness also significantly improved with the ibuprofen plaster compared with placebo; LS mean difference in algometry/tenderness AUC0-3d was 1.87 N/cm2*d and AUC0-5d was 1.87 N/cm2*d (P values ≤0.0004). At all study timepoints, a greater percentage of patients and investigators rated the effectiveness of the ibuprofen 200 mg plaster as good/excellent than the placebo plaster. Treatment-emergent adverse events for the ibuprofen plaster were few (≤1.5%) and were mild in severity. CONCLUSIONS The results of this study indicate 200 mg plaster is effective and safe for the treatment of pain due to acute sports-related traumatic blunt soft tissue injury/contusion in adults.
-
6.
Renal stress and kidney injury biomarkers in response to endurance cycling in the heat with and without ibuprofen.
McDermott, BP, Smith, CR, Butts, CL, Caldwell, AR, Lee, EC, Vingren, JL, Munoz, CX, Kunces, LJ, Williamson, K, Ganio, MS, et al
Journal of science and medicine in sport. 2018;(12):1180-1184
Abstract
UNLABELLED Exercise, especially in the heat, can contribute to acute kidney injury, which can expedite chronic kidney disease onset. The additional stress of ibuprofen use is hypothesized to increase renal stress. OBJECTIVES To observe the effects of endurance cycling in the heat on renal function. Secondarily, we investigated the effect of ibuprofen ingestion on kidney stress. DESIGN Randomized, placebo controlled and observational methods were utilized. METHODS Forty cyclists (52±9y, 21.7±6.5% body fat) volunteered and completed an endurance cycling event (5.7±1.2h) in the heat (33.2±5.0°C, 38.4±10.7% RH). Thirty-five participants were randomized to ingest a placebo (n=17) or 600mg ibuprofen (n=18) pre-event. A blood sample was drawn before and following the event. Serum creatinine was assessed by colorimetric assay. An ELISA was used to measure serum neutrophil gelatinase-associated lipocalin. Fractional excretion of sodium was calculated after urinary and serum electrolyte analyses. RESULTS Placebo versus ibuprofen groups contributed no significant difference in any variable (p>0.05). Serum creatinine significantly increased from pre- (0.52±0.14mg/dL) to post-event (0.88±0.21mg/dL; p<0.001). Serum neutrophil gelatinase-associated lipocalin significantly increased (pre: 68.51±17.54ng/mL; post: 139.12±36.52ng/mL; p<0.001) and fractional excretion of sodium was significantly reduced from pre- (0.52±0.24%) to post-event (0.27±0.18%; p<0.001). CONCLUSIONS Changes in renal biomarkers suggest mild acute kidney injury and reduced kidney function during a single bout of endurance cycling in the heat, without influence from moderate ibuprofen ingestion.
-
7.
Effects of Ibuprofen and Resistance Training on Bone and Muscle: A Randomized Controlled Trial in Older Women.
Duff, WR, Chilibeck, PD, Candow, DG, Gordon, JJ, Mason, RS, Taylor-Gjevre, R, Nair, B, Szafron, M, Baxter-Jones, A, Zello, GA, et al
Medicine and science in sports and exercise. 2017;(4):633-640
Abstract
INTRODUCTION/PURPOSE Resistance training with ibuprofen supplementation may improve musculoskeletal health in postmenopausal women. The study purpose was to determine the efficacy of resistance training and ibuprofen supplementation on bone and muscle properties in postmenopausal women. METHODS Participants (n = 90, 65.3 ± 4.9 yr) were randomly assigned to: supervised resistance training or stretching (placebo-exercise) with postexercise ibuprofen (400 mg) or placebo supplementation for 3 d·wk (9 months). Baseline and postintervention measurements included distal and shaft scans of the forearm and lower leg using peripheral quantitative computed tomography. Distal site outcomes included cross-sectional area, content, and density for total and trabecular bone, as well as estimated bone strength in compression. Shaft site outcomes included total bone area; cortical bone area, content, and density; estimated bone strength in torsion; and muscle area and density. RESULTS Exercise-supplement-time interactions for total bone content at the distal radius (P = 0.009) and cortical density at the radius shaft (P = 0.038) were significant. Resistance training with ibuprofen decreased total bone content (-1.5%) at the distal radius in comparison to the resistance training (0.6%; P = 0.032) and ibuprofen alone (0.5%; P = 0.050). Change in cortical density at the radius shaft differed between the stretching with placebo and ibuprofen supplementation groups (-1.8% vs 1.1%; P = 0.050). Resistance training preserved muscle density in the lower leg more so than stretching (-3.1% vs -5.4%; P = 0.015). CONCLUSIONS Ibuprofen consumed immediately after resistance training had a deleterious effect on bone mineral content at the distal radius, whereas resistance training or ibuprofen supplementation individually prevented bone loss. Resistance training prevented muscle density decline in the lower leg.
-
8.
Low Buffer Capacity and Alternating Motility along the Human Gastrointestinal Tract: Implications for in Vivo Dissolution and Absorption of Ionizable Drugs.
Hens, B, Tsume, Y, Bermejo, M, Paixao, P, Koenigsknecht, MJ, Baker, JR, Hasler, WL, Lionberger, R, Fan, J, Dickens, J, et al
Molecular pharmaceutics. 2017;(12):4281-4294
Abstract
In this study, we determined the pH and buffer capacity of human gastrointestinal (GI) fluids (aspirated from the stomach, duodenum, proximal jejunum, and mid/distal jejunum) as a function of time, from 37 healthy subjects after oral administration of an 800 mg immediate-release tablet of ibuprofen (reference listed drug; RLD) under typical prescribed bioequivalence (BE) study protocol conditions in both fasted and fed states (simulated by ingestion of a liquid meal). Simultaneously, motility was continuously monitored using water-perfused manometry. The time to appearance of phase III contractions (i.e., housekeeper wave) was monitored following administration of the ibuprofen tablet. Our results clearly demonstrated the dynamic change in pH as a function of time and, most significantly, the extremely low buffer capacity along the GI tract. The buffer capacity on average was 2.26 μmol/mL/ΔpH in fasted state (range: 0.26 and 6.32 μmol/mL/ΔpH) and 2.66 μmol/mL/ΔpH in fed state (range: 0.78 and 5.98 μmol/mL/ΔpH) throughout the entire upper GI tract (stomach, duodenum, and proximal and mid/distal jejunum). The implication of this very low buffer capacity of the human GI tract is profound for the oral delivery of both acidic and basic active pharmaceutical ingredients (APIs). An in vivo predictive dissolution method would require not only a bicarbonate buffer but also, more significantly, a low buffer capacity of dissolution media to reflect in vivo dissolution conditions.
-
9.
Analgesic Efficacy of a New Immediate-Release/Extended-Release Formulation of Ibuprofen: Results From Single- and Multiple-Dose Postsurgical Dental Pain Studies.
Christensen, S, Paluch, E, Jayawardena, S, Daniels, S, Meeves, S
Clinical pharmacology in drug development. 2017;(3):302-312
-
-
Free full text
-
Abstract
Analgesic effects of ibuprofen immediate-release/extended-release (IR/ER) 600-mg tablets were evaluated in 2 randomized, double-blind, placebo-controlled dental pain studies. Patients 16-40 years old with moderate-severe pain following third-molar extraction received single-dose ibuprofen 600 mg IR/ER (formulation A or B), naproxen sodium 220 mg, or placebo (2:2:2:1; study 1) or 4 doses of ibuprofen 600 mg IR/ER (formulation A) or placebo (1:1; study 2). In study 1 (n = 196), mean (standard deviation [SD]) time-weighted sum of pain intensity difference scores for placebo, ibuprofen IR/ER A, ibuprofen IR/ER B, and naproxen, respectively, were 0.05 (9.2), 16.87 (9.4), 17.34 (10.5), and 12.66 (10.0) over 0-12 hours and -0.03 (4.1), 6.57 (4.4), 7.14 (5.2), and 5.14 (5.0) over 8-12 hours (all P < .001 vs placebo). In study 2 (n = 106), mean (SD) time-weighted sum of pain relief and pain intensity difference scores were 18.2 (20.0) versus 41.5 (21.0) at 0-12 hours and 10.3 (12.0) versus 18.4 (12.1) at 8-12 hours for placebo versus ibuprofen IR/ER, respectively (P < .001 for both); efficacy was sustained over each of the four 12-hour dosing intervals with ibuprofen. Gastrointestinal adverse events predominated with placebo both after study medication administration and after rescue medication use, if applicable. Ibuprofen 600 mg IR/ER provided safe and effective analgesia after single and multiple doses.
-
10.
Comparison of paracetamol, ibuprofen, and diclofenac potassium for pain relief following dental extractions and deep cavity preparations.
Gazal, G, Al-Samadani, KH
Saudi medical journal. 2017;(3):284-291
Abstract
To compare the effectiveness of different oral analgesics for relieving pain and distress in adults following the extraction of teeth and deep cavity preparations under local anesthesia. Methods: This randomized controlled study was conducted between November 2015 and May 2016. One hundred and twenty patients were randomly allocated to 3 groups. Forty patients were in the paracetamol (1 gram) group, 40 in the ibuprofen (400 mg) group and 40 in the diclofenac potassium (50 mg) group. Evaluation of the post extraction and deep cavity preparations pain was made by patients immediately postoperatively, 2, 4 and 6 hours postoperatively on standard 100 mm visual analogue scales (VAS). Furthermore, each patient was observed preoperatively and immediately postoperatively for signs of distress by using a 5 point face scale. Results: There were significant decreases in mean pain VAS scores for diclofenac potassium group compared to paracetamol and ibuprofen groups at 4 hours postoperatively (one-way Analysis of Variance: p=0.0001, p=0.001) and 6 hours postoperatively (p=0.04, p=0.005). Changes in distress scores from the preoperative score to the postoperative score were made using the paired sample t-test. There were significant decreases in distress scores between the preoperative and postoperative scores (p=0.0001). Conclusions: Diclofenac potassium was more effective than paracetamol or ibuprofen for reducing postoperative pain associated with tooth extraction and deep cavity preparation. Patients' distress levels can be alleviated by using preemptive analgesics.