Patients treated using the new IM sedation protocol were compared to historical
controls. The historical controls were taken from the period prior when the existing practice was to predominantly use IV sedation. The structured IM sedation protocol was introduced as part of a clinical trial comparing droperidol (10 mg), midazolam (10 mg) and a combination of droperidol (5 mg) and midazolam (5 mg). The clinical trial is described in detail elsewhere. Ethics approval was obtained for the historical control study from the Human Research Ethics Committee. The hospital where the study was undertaken has a tertiary toxicology unit, and although there are only 27,000 presentation to the ED OTX015 solubility dmso annually, there is a high proportion Inhibitors,research,lifescience,medical of patients with agitation, delirium, Inhibitors,research,lifescience,medical aggression and acute behavioural disorders because the hospital provides a regional clinical toxicology service and Drug and Alcohol Unit. Selection of Participants The study compared patients treated with the new structured IM sedation protocol during an eight month period from August 2008 to March 2009 to a group of historical control patients sedated Inhibitors,research,lifescience,medical in the ED in the eight month period immediately before the protocol was introduced (November 2007
to June 2008). The structured IM sedation protocol consisted of: 1.An intramuscular injection of the clinical trial drug, which was labelled and kept in the ED. 2.A defined approach to monitoring of the patient’s vital signs over a six hour period 3.The introduction and use of a sedation score to be included as part of the standard observation of the patient 4.Recording of further Inhibitors,research,lifescience,medical sedation, adverse events, staff or patient injury for all patients. 5.Route and type of additional sedation
was dictated by the treating clinician. Inclusion criteria for both the historical controls (use Inhibitors,research,lifescience,medical of predominantly IV parenteral sedation) and the intervention group (IM sedation only) were that the patient required both physical and chemical restraint, the patient did not consent to IV or oral sedation and they required the presence of the hospital security. To identify and ensure that the historical control group was similar to patients during the new IM sedation protocol we accessed the hospital security log for both time periods. The security log documents all security responses to ABD in the ED and has previously Parvulin been shown to be the most accurate record of patients with ABD. Medical records were retrieved for all patients who had required security to attend the ED and only patients meeting the inclusion criteria were included. Exclusion criteria were successful verbal de-escalation, agreement to oral or IV sedation, previous administration of other sedative medication or the patient did not remain in the ED (escorted off premises by police, absconded) (Figure (Figure11).