The Opioid Analgesic Reduction Study (OARS) Pilot: A Double-Blind Randomized Multicenter Trial.

BACKGROUND: With addiction rates and opioid deaths increasing, health care providers are obligated to help stem the opioid crisis. As limited studies examine the comparative effectiveness of fixed-dose combination nonopioid analgesia to opioid-containing analgesia, a comparative effectiveness study was planned and refined by conducting a pilot study. METHODS: The Opioid Analgesic Reduction Study (OARS) pilot, a stratified, randomized, multisite, double-blind clinical trial, was designed to test technology and procedures to be used in the full OARS trial. Participants engaged in the full protocol, enabling the collection of OARS outcome data. Eligible participants reporting to 1 of 5 sites for partial or full bony impacted mandibular third molar extraction were stratified by biologic sex and randomized to 1 of 2 treatment groups, OPIOID or NONOPIOID. OPIOID participants were provided 20 doses of hydrocodone 5 mg/acetaminophen 300 mg. NONOPIOID participants were provided 20 doses of ibuprofen 400 mg/acetaminophen 500 mg. OARS outcomes data, including pain experience, adverse effects, sleep quality, pain interference, overall satisfaction, and remaining opioid tablets available for diversion, were collected via surveys, electronic medication bottles, eDiary, and activity/sleep monitor. RESULTS: Fifty-three participants were randomized with 50 completing the OARS pilot protocol. Across all outcome pain domains, in all but 1 time period, NONOPIOID was better in managing pain than OPIOID (P < 0.05 level). Other outcomes suggest less pain interference, less adverse events, better sleep quality, better overall satisfaction, and fewer opioid-containing tablets available for diversion. DISCUSSION: Results suggest patients requiring impacted mandibular third molar extraction would benefit from fixed-dose combination nonopioid analgesia. KNOWLEDGE TRANSFER STATEMENT: Study results suggest fixed-dose nonopioid combination ibuprofen 400 mg/acetaminophen 500 mg is superior to opioid-containing analgesic (hydrocodone 5 mg/acetaminophen 500 mg). This knowledge should inform surgeons and patients in the selection of postsurgical analgesia.

Alloplastic total temporomandibular joint replacement in skeletally immature patients: a pilot survey.

The aim of this study was to survey an international group of temporomandibular joint surgeons regarding their outcomes with alloplastic total joint replacement in skeletally immature patients and to review the literature linked to autogenous reconstruction and alloplastic replacement of the temporomandibular joint (TMJR) in this population. A total of 24 custom/patient-specific TMJ Concepts devices were implanted into 14 patients (eight male and six female). Their mean age was 14 years (range 7-17 years). Nine (64.3%) had bilateral devices and five (35.7%) had unilateral devices. The most prevalent diagnosis was idiopathic condylar resorption (33.3%), followed by ankylosis (16.7%). Concurrent orthognathic surgery was performed in four patients (28.6%). The TMJR was completed as a one-stage procedure in 11 patients (78.6%) and in two stages in three patients (21.4%). All surgeons reported improvements in maximum incisal opening with good function. The respondents reported no asymmetric mandibular growth or retrognathia after either bilateral or unilateral TMJR implantation. This pilot study indicates that the use of TMJR in the growing patient may be a useful modality in select cases. The encouraging results of experienced surgeons demonstrate and support the need for further studies on the utilization of TMJR in this patient population.

Fracture propagation associated with intermaxillary fixation screws in maxillofacial trauma.

Intermaxillary fixation (IMF) screws are commonly used for maxillomandibular immobilization in the management of mandible fractures as definitive closed reduction treatment or in adjunct intraoperatively. In this report, we present three cases of isolated unilateral mandible fractures, in which IMF screws were used and resulted in propagation of a second fracture on the contralateral side, at the site where IMF screws were placed during the surgery. The use of IMF screws has many advantages with an overall low risk of morbidity, however, there are potential complications that must be recognized.

Management of self-inflicted gunshot wounds to the face: retrospective review from a single tertiary care trauma centre.

There are limited published data about the surgical management of self-inflicted facial gunshot wounds. The aim of this retrospective study was to review our management of subjects who initially survive such a wound and were admitted to a tertiary care trauma centre between 2002 and 2012. Only subjects with definitive evidence of a self-inflicted facial gunshot wound and who were admitted alive were included. Data collected included personal and clinical details, characteristics of the gunshot wound, and medical and surgical management. Types of operations and their duration were recorded, and primary reconstruction was divided into early (within the first 48hours after presentation) or delayed (longer than 48hours). Determinants of infection were assessed with univariate analysis. Seventy-six subjects (65 male and 11 female, mean (range) age 44 (18-83) years) were included in the study. Twenty-five patients needed an early surgical airway and five needed emergency intervention to control haemorrhage. Forty-five patients had primary reconstructions (28 early and 17 delayed) and 12 who were treated by delayed repair had a submental entry site to the wound. There were no significant differences in infection rates between those who had early, compared with those who had late, reconstructions. Early primary reconstruction can be successful for patients with self-inflicted facial gunshot wounds, particularly when the entry point of the bullet is in the upper and midface area. Delayed primary reconstruction was more common when the bullet entered the lower face.

Factors affecting survival following self-inflicted head and neck gunshot wounds: a single-centre retrospective review.

Self-inflicted head and neck gunshot wounds are a common modality of suicide in the USA. This study reviewed all self-inflicted head and neck gunshot wound patients with complete records (n=157) treated at a tertiary centre between 2002 and 2012 inclusive. The associations between mortality and patient/clinical variables were evaluated with the χ(2) test or Fisher's exact test for statistical difference testing. Outcomes recorded were death (n=92, 59%), discharge to long-term care/rehabilitation (n=58, 37%), and discharge home (n=7, 4%). The majority of patients were male (86.6%) and single/separated/divorced (55.5%). The mortality rate by site, in descending order, was temporal 82%, frontal scalp 69%, submental/intraoral 30%, and neck 25%. Involvement of the central nervous system (n=127) resulted in a 70% mortality, but a lower mortality was observed among patients with an avulsion injury (P=0.025). A tracheostomy within 24h of admission was statistically associated with improved survival (P<0.001), but confounding factors were found. Multivariate analysis revealed increasing age, temporal entry site, and the severity of central nervous system involvement to be positively associated with an increased mortality.

Osteochondroma of the condyle: review of 8 cases.

This study is a retrospective review of the records of all cases treated in the authors' department since 1991 to identify patients with condylar masses diagnosed as osteochondromas. In 2186 cases of benign and malignant cysts/tumours of the maxillofacial region (1560 malignant and 626 benign), 8 osteochondromas of the mandibular condyle were identified. These 8 cases and the current English literature are reviewed.

The measurement of drug-induced calcium changes in vascular smooth muscle using X-ray microanalysis of pyroantimonate precipitates.

A method is described for the X-ray microanalysis of calcium pyroantimonate precipitates in smooth muscle using an electron microscope. Stimulation of calcium influx through voltage-operated channels using KCl and blockade of this effect with nifedipine were used to validate the method. Significant changes in the calcium content of rat renal artery were detected when osmium tetroxide-pyroantimonate were used as fixatives, whereas addition of glutaraldehyde yielded unsatisfactory data. Some effects of hydralazine are also briefly described.

Cardiovascular and autonomic actions of ciclazindol and tricyclic antidepressants.

The novel antidepressant ciclazindol had no significant effect on blood pressure at doses of up to 25.6 mg/kg i.v. in anaesthetised rats. Desipramine, imipramine, nortriptyline and amitriptyline evoked significant decreases at 0.8-1.6 mg/kg. Ciclazindol had no sustained haemodynamic actions in anaesthetised cats apart from a small rise in dp/dt. The ECG waveform showed only minor voltage changes. Desipramine and nortriptyline elevated haemodynamic variables at low doses but decreases occurred at higher doses. Amitripyline and imipramine decreased blood pressure. ECG changes evoked by the tricyclics included QRS complex distortion, ventricular ectopic beats, nodal rhythm, bundle branch block and ventricular tachycardia. In skin wheal tests ciclazindol was equiactive with the tricyclics as a local anaesthetic. In isolated tissues ciclazindol was not anticholinergic, showed no marked antagonism of 5-HT, potentiated responses to noradrenaline and was weakly antihistaminic. Ciclazindol appears to be pharmacologically different from the tricyclics and may not produce the unwanted side effects associated with these compounds.