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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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Intravenous dexketoprofen versus paracetamol in non-traumatic musculoskeletal pain in the emergency department: A randomized clinical trial.
Demirozogul, E, Yilmaz, A, Ozen, M, Turkcuer, I, Seyit, M, Arikan, C
The American journal of emergency medicine. 2019;(12):2136-2142
Abstract
INTRODUCTION Although acute musculoskeletal pain has a wide range of causes from tendinitis, muscle spasm, to bone and joint injuries, it is a frequent occurrence in emergency services. Paracetamol and non-steroidal anti-inflammatory analgesics (NSAID) are common used in the treatment of musculoskeletal pain. This study sets out to compare the effectiveness of intravenous dexketoprofen and paracetamol in musculoskeletal pain relief. METHODS This prospective, randomized, double blind, controlled study was carried out in a university emergency room. The participating patients were randomized into two groups to receive either 50 mg of dexketoprofen or 1000 mg of paracetamol intravenously by rapid infusion in 150 ml of normal saline. Visual analogue scale (VAS), Numeric Rating Scala (NRS) was employed for pain measurement at baseline, after 15, after 30 and after 60 mins. RESULTS 200 patients were included in the study, excluding 7342 of them. The mean age of the patients was calculated as 32,6. Paracetamol and dexketoprofen intervention decreases NRS pain scores over time. When compared to all pain locations, the NRS pain score of the patients was found to be statistically more effective in dexketoprofen than in paracetamol (p = 0.001). Paracetamol and dexketoprofen intervention reduces pain VAS scores over time. When the VAS pain score of the patients was compared to all pain locations, dexketoprofen was found to be statistically more effective than paracetamol (p = 0.001). CONCLUSION Intravenous dexketoprofen seemed to achieve superior analgesia to intravenous paracetamol when compared with all pain locations in patients with non-traumatic musculoskeletal pain.
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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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Intravenous vs Oral Acetaminophen for Analgesia After Cesarean Delivery: A Randomized Trial.
Wilson, SH, Wolf, BJ, Robinson, SM, Nelson, C, Hebbar, L
Pain medicine (Malden, Mass.). 2019;(8):1584-1591
Abstract
OBJECTIVE Examination of postoperative analgesia with intravenous and oral acetaminophen. DESIGN Prospective, three-arm, nonblinded, randomized clinical trial. SETTING A single academic medical center. SUBJECTS Parturients scheduled for elective cesarean delivery. METHODS This trial randomized 141 parturients to receive intravenous acetaminophen (1 g every eight hours, three doses), oral acetaminophen (1 g every eight hours, three doses), or no acetaminophen. All patients received a standardized neuraxial anesthetic with intrathecal opioids and scheduled postoperative ketorolac. The primary outcome, 24-hour opioid consumption, was evaluated using the Kruskal-Wallace test and Tukey-Kramer adjustment for multiple comparisons. Secondary outcomes included 48-hour opioid consumption, first opioid rescue, pain scores, patient satisfaction, times to ambulation and discharge, and side effects. RESULTS Over 18 months, 141 parturients with similar demographic variables completed the study. Median (interquartile range) opioid consumption in intravenous morphine milligram equivalents at 24 hours was 0 (5), 0 (7), and 5 (7) for the intravenous, oral, and no groups, respectively, and differed between groups (global P = 0.017). Opioid consumption and other secondary outcomes did not differ between the intravenous vs oral or oral vs no groups. Opioid consumption was reduced at 24 hours with intravenous vs no acetaminophen (P = 0.015). Patients receiving no acetaminophen had 5.8 times the odds of consuming opioids (P = 0.036), consumed 40% more opioids controlling for time (P = 0.041), and had higher pain scores with ambulation (P = 0.004) compared with the intravenous group. CONCLUSIONS Intravenous acetaminophen did not reduce 24-hour opioid consumption or other outcomes compared with oral acetaminophen. Intravenous acetaminophen did decrease opioid consumption and pain scores compared with no acetaminophen.
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Effect of ibuprofen on semen quality.
Banihani, SA
Andrologia. 2019;(4):e13228
Abstract
Ibuprofen is a widely used analgesic/antipyretic medication belongs to the nonsteroidal anti-inflammatory class. Even though the influence of ibuprofen on semen quality has been investigated in various occasions, the comprehensive understanding and discussion of its impact on semen quality is still yet to be determined. In this work, we systematically review and reveal the effect of ibuprofen on semen quality, and thus on fertilising capability. To achieve this goal, we searched the main research databases (Scopus and PubMed) from 1 June 1986 through 13 October 2018 for English-language articles and abstracts using the keywords "ibuprofen" versus "semen" and "sperm". In addition, related published articles or abstracts were also discussed if relevant. Altogether, the main stream of research, from both in vitro and in vivo studies, presents an adverse effect of ibuprofen on different sperm parameters such as motility, viability, count and DNA integrity; however, such effect is not yet confirmed in humans. Mechanisms by which ibuprofen affects semen quality may be by reducing testosterone and prostaglandin synthesis, chelating zinc ions and inhibiting nitric oxide synthesis. However, further research studies, mainly clinical, are still of great importance to confirm the effects of ibuprofen on semen quality.
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Intravenous paracetamol versus dexketoprofen in acute musculoskeletal trauma in the emergency department: A randomised clinical trial.
Yilmaz, A, Sabirli, R, Ozen, M, Turkcuer, I, Erdur, B, Arikan, C, Demirozogul, E, Sarohan, A, Seyit, M, Ok, N
The American journal of emergency medicine. 2019;(5):902-908
Abstract
INTRODUCTION Musculoskeletal system traumas are among the most common presentations in the emergency departments. In the treatment of traumatic musculoskeletal pain, paracetamol and non-steroidal anti-inflammatory analgesics (NSAID) are frequently used. Our aim in this study is to compare the efficacy of intravenous dexketoprofen and paracetamol in the treatment of traumatic musculoskeletal pain. METHODS This prospective, randomised, double blind, controlled study was conducted in a tertiary care emergency unit. The participating patients were randomised into two groups to receive either 50 mg of dexketoprofen or 1000 mg of paracetamol intravenously by rapid infusion in 150 mL of normal saline. Visual analogue scale (VAS), Numeric Rating Scala (NRS) and Verbal Rating Scale (VRS) was employed for pain measurement at baseline, after 15, after 30 and after 60 mins. RESULTS 200 patients were included in the final analysis. The median age of the paracetamol group was 34 (24-48), while that of the dexketoprofen group was 35 (23-50), and 63% (n = 126) of them consisted of men. Paracetamol and dexketoprofen administration reduced VAS pain scores over time (p = 0.0001). Median reduction in VAS score at 60 min was 55 (IQR 30-65) for the paracetamol group and 50(IQR 30.25-60) for the dexketoprofen group. There was no statistically significant difference between the paracetamol and dexketoprofen groups in terms of VAS reductions (p = 0.613). CONCLUSION Intravenous paracetamol and dexketoprofen seem to produce equivalent pain relief for acute musculoskeletal trauma in the emergency department. CLINICALTRIALS. GOV NO NCT03428503.
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Tramadol/dexketoprofen (TRAM/DKP) compared with tramadol/paracetamol in moderate to severe acute pain: results of a randomised, double-blind, placebo and active-controlled, parallel group trial in the impacted third molar extraction pain model (DAVID study).
Gay-Escoda, C, Hanna, M, Montero, A, Dietrich, T, Milleri, S, Giergiel, E, Zoltán, TB, Varrassi, G
BMJ open. 2019;(2):e023715
Abstract
OBJECTIVES To compare efficacy/safety of oral tramadol 75 mg/dexketoprofen 25 mg (TRAM/DKP) and TRAM 75 mg/paracetamol 650 mg (TRAM/paracetamol) in moderate to severe pain following surgical removal of impacted lower third molar. DESIGN Multicentre, randomised, double-blind, placebo-controlled, phase IIIb study. PARTICIPANTS Healthy adult patients scheduled for surgical extraction of at least one fully/partially impacted lower third molar requiring bone manipulation. 654 patients were randomised and 653 were eligible for analysis. INTERVENTIONS Surgery was performed under local anaesthetic. No sedation was permitted. Patients rated pain intensity (PI) using an 11-Numerical Rating Scale (NRS) (0 no pain; 10 worst pain). Participants experiencing moderate/severe pain (≥4) within 4 hours of surgery were randomised (2:2:1 ratio) to a single oral dose of TRAM/DKP 75/25 mg, TRAM/paracetamol 75/650 mg or placebo. MAIN OUTCOME MEASURES Efficacy was based patients' electronic diaries. Analgesia and pain were recorded as follows: pain relief (PAR) on a 5-point Verbal Rating Scale (0='no relief', 1='a little (perceptible) relief', 2='some (meaningful) relief', 3='lot of relief', 4='complete relief') at the predefined postdose time points t15 min, t30 min, t1 hour, t1.5 hour, t2 hour, t4 hour, t6 hour and t8 hour and PI on the 11-point NRS at t0 and at the same predefined postdose time points. Onset of analgesia documented using double stopwatch method over a 2-hour period. Primary endpoint was total pain relief over 6 hours (TOTPAR6). Rescue medication was available during the treatment period. RESULTS TRAM/DKP was superior to TRAM/paracetamol and placebo at the primary endpoint TOTPAR6 (p<0.0001). Mean (SD) TOTPAR6 in the TRAM/DKP group was 13 (6.97), while those in the active control and placebo groups were 9.2 (7.65) and 1.9 (3.89), respectively. Superiority of TRAM/DKP over active comparator and placebo was observed at all secondary endpoints. Incidence of adverse events was comparable between active groups. CONCLUSIONS TRAM/DKP (75/25 mg) is effective and superior to TRAM/paracetamol (75/650 mg) in relieving moderate to severe acute pain following surgical removal of impacted lower third molar, with a faster onset of action, greater and durable analgesia, together with a favourable safety profile. TRIAL REGISTRATION NUMBER EudraCT 2015-004152-22 and NCT02777970.
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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
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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.
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Oral Diclofenac Potassium Versus Intravenous Acetaminophen in Acute, Isolated, Closed-Limb Trauma.
Momeni, M, Vahidi, E, Badrizadeh, M, Naderpour, Z, Saeedi, M
Advanced emergency nursing journal. 2019;(1):48-55
Abstract
Pain control is an important concern in limb trauma. The most ideal agent for this purpose varies among different hospitals. The objective of this study was to compare the analgesic effect of oral diclofenac potassium versus intravenous acetaminophen in patients with limb trauma. This was a double-blind randomized clinical trial conducted on 60 adult patients. Oral diclofenac potassium (50 mg) was given in Group D, and intravenous acetaminophen (1 g in 500 ml normal saline over 20 min) was administered in Group A. Patients' pain scores (visual analogue scale) were recorded and compared at baseline, 5, 15, 30, 60 min, and 4 hr after drug administration. The mean age was 42.62 ± 15.42 and 38.04 ± 17.48 years in Group A and Group D, respectively. No significant change was observed between the 2 groups (p = 0.11). In this study, both drugs could decrease the pain score effectively and safely in isolated limb trauma.
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MicroRNA from a 12-h versus 20-h acetylcysteine infusion for paracetamol overdose.
Wong, A, Nejad, C, Gantier, M, Choy, KW, Doery, J, Graudins, A
Human & experimental toxicology. 2019;(6):646-654
Abstract
Paracetamol overdose is common and microRNA (miR)-122 expression is increased with liver injury. We aimed to measure miR-122 in the setting of an abbreviated paracetamol overdose treatment regimen. We compared miRNA expression in patients treated for paracetamol poisoning with an abbreviated 12-h intravenous acetylcysteine regimen (200 mg/kg over 4 h, 50 mg/kg over 8 h) or a 20-h regimen (200 mg/kg over 4 h, 100 mg/kg over 16 h) (NACSTOP trial). miR-122 expression is increased (decreased cycle threshold (Ct) values) with paracetamol liver injury. We assessed miR-122 expression in patients receiving the two acetylcysteine regimens and in a separate group with acute liver injury (ALI). We examined 121 blood samples in 38 patients. After 20 h of acetylcysteine, median alanine transaminase (ALT) was 12 U/L (18, 14) versus 16 U/L (11, 21) ( p = 0.17) and median miR-122 Ct was 30.1 (interquartile range (IQR): 28.9, 33.3) versus 31.4 (28.9, 33.9) ( p = 0.7) in the NACSTOP abbreviated and control groups, respectively. Median normalized miR-122 Ct after 20 h of acetylcysteine was 2.2 (IQR 1.9, 6.4), 1.1 (0.7, 2.9), 63.9 (2.5, 168), 123.2 (40.9, 207.8) in the NACSTOP-abbreviated, NACSTOP-control, ALI and hepatotoxicity groups, respectively. There was no significant difference in ALT or miRNA between NACSTOP treatment groups and no signal of increased liver injury from an abbreviated 12-h acetylcysteine regimen. These findings suggest that an abbreviated acetylcysteine regimen in low-risk patients who have overdosed on paracetamol is safe. Further study is required to validate this finding utilizing miRNA as a comparative biomarker.