Analgesic effect of oral paracetamol 1000 mg/ibuprofen 400 mg, paracetamol 1000 mg/codeine 60 mg, paracetamol 1000 mg/ibuprofen 400 mg/codeine 60 mg, or placebo on acute postoperative pain: a single-dose, randomized, and double-blind study.

PURPOSE: Combining analgesics with different mechanisms of action may increase the analgesic efficacy. The multidimensional pharmacodynamic profiles of ibuprofen 400 mg/paracetamol 1000 mg, ibuprofen 400 mg/paracetamol 1000 mg/codeine 60 mg, and paracetamol 1000 mg/codeine 60 mg and placebo were compared. METHODS: A randomized, double-blind, placebo-controlled, parallel-group, single-centre, outpatient, and single-dose study used 200 patients of both sexes and homogenous ethnicity after third molar surgery (mean age 24 years, range 19-30 years). Primary outcome was sum pain intensity over 6 h (SPI). Secondary outcomes were time to analgesic onset, duration of analgesia, time to rescue drug intake, number of patients taking rescue drug, sum pain intensity difference (SPID), maximum pain intensity difference, time to maximum pain intensity difference, number needed to treat, prevent remedication and harm values, adverse effects, and patient-reported outcome measure (PROM). RESULTS: Analgesia following ibuprofen and paracetamol combination with or without codeine was comparable. Both were better than paracetamol combined with codeine. Secondary variables supported this finding. Post hoc analysis of SPI and SPID revealed a sex/drug interaction trend in the codeine-containing groups where females experienced less analgesia. PROM showed a significant sex/drug interaction in the paracetamol and codeine group, but not in the other codeine-containing group. Especially females reported known and mild side effects in the codeine-containing groups. CONCLUSION: Codeine added to ibuprofen/paracetamol does not seem to add analgesia in a sex-mixed study population. Sex may be a confounding factor when testing weak opioid analgesics such as codeine. PROM seems to be more sensitive than traditional outcome measures. TRIAL REGISTRATION: ClinicalTrials.gov June 2009 NCT00921700.

Analgesic effect of oral ibuprofen 400, 600, and 800 mg; paracetamol 500 and 1000 mg; and paracetamol 1000 mg plus 60 mg codeine in acute postoperative pain: a single-dose, randomized, placebo-controlled, and double-blind study.

PURPOSE: Effect size estimates of analgesic drugs can be misleading. Ibuprofen (400 mg, 600 mg, 800 mg), paracetamol (1000 mg, 500 mg), paracetamol 1000 mg/codeine 60 mg, and placebo were investigated to establish the multidimensional pharmacodynamic profiles of each drug on acute pain with calculated effect size estimates. METHODS: A randomized, double-blind, single-dose, placebo-controlled, parallel-group, single-centre, outpatient, and single-dose study used 350 patients (mean age 25 year, range 18 to 30 years) of homogenous ethnicity after third molar surgery. Primary outcome was sum pain intensity over 6 h. Secondary outcomes were time to analgesic onset, duration of analgesia, time to rescue drug intake, number of patients taking rescue drug, sum pain intensity difference, maximum pain intensity difference, time to maximum pain intensity difference, number needed to treat values, adverse effects, overall drug assessment as patient-reported outcome measure (PROM), and the effect size estimates NNT and NNTp. RESULTS: Ibuprofen doses above 400 mg do not significantly increase analgesic effect. Paracetamol has a very flat analgesic dose-response profile. Paracetamol 1000/codeine 60 mg gives similar analgesia as ibuprofen from 400 mg, but has a shorter time to analgesic onset. Active drugs show no significant difference in maximal analgesic effect. Other secondary outcomes support these findings. The frequencies of adverse effects were low, mild to moderate in all active groups. NNT and NTTp values did not coincide well with PROMs. CONCLUSION: Ibuprofen doses above 400 mg for acute pain offer limited analgesic gain. Paracetamol 1000 mg/codeine 60 mg is comparable to ibuprofen doses from 400 mg. Calculated effect size estimates and PROM in our study seem not to relate well as clinical analgesic efficacy estimators. TRIAL REGISTRATION: NCT00699114.

Motor vehicle accidents-related maxillofacial injuries: a multicentre and prospective study.

OBJECTIVES: The purpose of this European multicenter prospective study was to obtain more precise information about the demographic characteristics and etiologic/epidemiologic patterns of motor vehicle accidents (MVA)-related maxillofacial fractures. STUDY DESIGN: Of the 3260 patients with maxillofacial fractures admitted within the study period, 326 traumas were caused by MVAs with a male/female ratio of 2.2:1. RESULTS: The maximum incidence was found in Zagreb (Croatia) (18%) and the minimum in Bergen (Norway) (0%). The most frequent mechanisms were car accidents, with 177 cases, followed by motorcycle accidents. The most frequently observed fracture involved the mandible, with 199 fractures, followed by maxillo-zygomatic-orbital (MZO) fractures. CONCLUSIONS: In all the 3 groups (car, motorcycle, and pedestrian), mandibular and MZO fractures were the 2 most frequently observed fractures, with some variations. The importance of analyzing MVA-related facial injuries and their features and characteristics should be stressed.

Assault-related maxillofacial injuries: the results from the European Maxillofacial Trauma (EURMAT) multicenter and prospective collaboration.

OBJECTIVE: The aim of this study is to present and discuss the demographic characteristics and patterns of assault-related maxillofacial fractures as reported by a European multicenter prospective study. STUDY DESIGN: Demographic and injury data were recorded for each patient who was a victim of an assault. RESULTS: Assaults represented the most frequent etiology of maxillofacial trauma with an overall rate of 39% and the values ranging between 60.8% (Kiev, Ukraine) and 15.4% (Bergen, Norway). The most frequent mechanisms of assault-related maxillofacial fractures were fists in 730 cases, followed by kicks and fists. The most frequently observed fracture involved the mandible (814 fractures), followed by orbito-zygomatic-maxillary complex fractures and orbital fractures. CONCLUSIONS: Our data confirmed the strong possibility that patients with maxillofacial fractures may be victims of physical aggression. The crucial role of alcohol in assault-related fractures was also confirmed by our study.

European Maxillofacial Trauma (EURMAT) in children: a multicenter and prospective study.

OBJECTIVE: The aim of this study is to present and discuss the results of a European multicentre prospective study about pediatric maxillofacial trauma epidemiology during a year. STUDY DESIGN: The following data were recorded: gender, age, etiology, site of fracture, date of injury. Of the 3396 patients with maxillofacial fractures admitted within the study period, 114 (3.3%) were children aged 15 years and younger, with a male/female ratio of 2.6:1. Mean age was 10.9 years. Most patients (63%) were aged 11-15 years. RESULTS: The most frequent cause of injury was fall (36 patients). Sport injuries and assaults were almost limited to the oldest group, whereas falls were more uniformly distributed in the 3 groups. The most frequently observed fracture involved the mandible with 47 fractures. In particular, 18 condylar fractures were recorded, followed by 12 body fractures. CONCLUSIONS: Falls can be acknowledged as the most important cause of facial trauma during the first years of life. The high incidence of sport accidents after 10 years may be a reason to increase the use of mouthguards and other protective equipment. Finally, the mandible (and in particular the condyle) was confirmed as the most frequent fracture site.

European Maxillofacial Trauma (EURMAT) project: a multicentre and prospective study.

The purpose of this study was to analyse the demographics, causes and characteristics of maxillofacial fractures managed at several European departments of oral and maxillofacial surgery over one year. The following data were recorded: gender, age, aetiology, site of facial fractures, facial injury severity score, timing of intervention, length of hospital stay. Data for a total of 3396 patients (2655 males and 741 females) with 4155 fractures were recorded. The mean age differed from country to country, ranging between 29.9 and 43.9 years. Overall, the most frequent cause of injury was assault, which accounted for the injuries of 1309 patients; assaults and falls alternated as the most important aetiological factor in the various centres. The most frequently observed fracture involved the mandible with 1743 fractures, followed by orbital-zygomatic-maxillary (OZM) fractures. Condylar fractures were the most commonly observed mandibular fracture. The results of the EURMAT collaboration confirm the changing trend in maxillofacial trauma epidemiology in Europe, with trauma cases caused by assaults and falls now outnumbering those due to road traffic accidents. The progressive ageing of the European population, in addition to strict road and work legislation may have been responsible for this change. Men are still the most frequent victims of maxillofacial injuries.

Comparison of perioperative morbidity after LeFort III and monobloc distraction osteogenesis.

We have compared distraction by monobloc and LeFort III osteotomy in the treatment of midfacial retrusion. We treated 14 patients with midface distraction (Crouzon syndrome (n = 9), Apert disease (n = 3), and other (n = 2)), 7 of whom had monobloc distraction and 7 who had LeFort III osteotomy. We compared duration of operation, peroperative blood loss, and complications. The two groups were comparable with respect to diagnosis, type of distraction (internal or external device), and duration of distraction. The operating time was longer in the monobloc than in the LeFort III group, but not significantly so (p = 0.09). The weight-adjusted blood losses were significantly different (66 ml/kg and 34 ml/kg, respectively (p = 0.05). The two groups had similar numbers of complications (p = 0.3), and similar duration of hospital stay. Both techniques seem safe. The choice of operation, therefore, should be tailored to the individual patient and the monobloc procedure should be used if indicated.

[A nine-year-old girl with a blue eye]. / En ni år gammel jente med blått øye.

We present a nine-year-old girl with fracture of the orbital floor and herniation of soft tissue and extraocular musculature into the maxillary sinus. A marked restriction of upward gaze was noted. Surgery was performed after two days. Herniated tissue was released and the orbital floor reconstructed. One week later she had normal eye motility. Orbital fractures of children are rare, but we stress the importance of careful clinical examination and early surgery. Due to the elasticity of the bone and lack of periorbital fat in children, extraocular musculature is more prone to entrapment in the orbital floor. The most important sign is limitation of gaze upwards. CT findings are of less importance. Early surgical management within 24 - 48 hours will reduce the risk of necrosis and fibrosis of extraocular musculature resulting in reduced eye motility.

Monobloc distraction osteogenesis in pediatric patients with severe syndromal craniosynostosis.

The management of the hypoplastic midface in syndromic craniosynostosis remains a great challenge. Frequently, patients have to be operated on numerous times to achieve a satisfactory end result, partially because of the limited skeletal advancement possible when using traditional surgical techniques. During the last decade, however, methods for gradual midfacial distraction have been presented, whereby greater advancements can be obtained. We present four children aged 17 months to 15 years with severe syndromal craniosynostosis in need of midface advancements because of severe respiratory obstruction or severe exophthalmos. These patients were complex cases with several previous craniofacial surgeries (mean of three times, range of two to six times) that yielded insufficient skeletal advancements. They were operated on with gradual monobloc advancements using the Modular Internal Distraction System. The mean length of operations was 370 minutes (range: 240-455 minutes), and the mean amount of perioperative blood transfusion needed was 1,300 ml (range: 280-2,700 ml) or 66.9 ml/kg (range: 31.1-94.9 ml/kg). The patient with the greatest number of previous operations also had the longest operation time as well as the most blood loss. The average midface advancement obtained was 25 mm (range: 20-30 mm), resulting in cessation or a significant decrease of preoperative respiratory problems, reduced exophthalmos, and improved facial profile. Apart from a local infection in one patient with a connective tissue disorder and several previous wound infections, no major postoperative complications were recorded. Distraction osteogenesis has become a versatile and safe technique that allows for large advancements of the midface.

Effect of ketamine, an NMDA receptor inhibitor, in acute and chronic orofacial pain.

We examined the analgesic effect of racemic ketamine and its 2 enantiomers in 16 female patients (age: 20-29 years) suffering acute pain after oral surgery and in 7 female patients (age: 42-79 years) suffering chronic neuropathic orofacial pain. All 3 forms of ketamine consistently relieved postoperative pain, (S)-ketamine being 4 times more potent than (R)-ketamine. The analgesic effect was maximal 5 min after i.m. injection and lasted for about 30 min. The 7 patients with neuropathic pain received ketamine at one or several occasions. Four patients (age: 54-79 years) who had suffered pain for more than 5 years did not experience an analgesic effect, whereas 3 patients (age: 42-53 years) who had suffered pain for less than 3 years reported pain relief lasting from 24 h to 3 days. The individual type of response did not depend on the form of ketamine used. The mental side effects were qualitatively similar for the 3 forms of ketamine. Relative to the analgesic effect (S)-ketamine caused more disturbing side effects than did (R)-ketamine. The mean serum concentration of each form of ketamine at the time of maximal effect was close to the approximate Kd value for PCP site occupancy by that particular form. This is in concert with the hypothesis that the effect of ketamine on acute nociceptive pain is due to N-methyl-D-aspartate (NMDA) receptor inhibition and adds to the evidence that NMDA receptors are important for the perception of acute, nociceptive pain in humans.(ABSTRACT TRUNCATED AT 250 WORDS)