Buccal acetaminophen provides fast analgesia: two randomized clinical trials in healthy volunteers

Abstract

BackgroundAcetaminophen (APAP) by oral or intravenous (iv) routes is used for mild to moderate pain but may take time to be effective. When fast relief is required and/or oral or iv routes are not available because of the patient’s condition, the transmucosal route may be an alternative.MethodologyA new transmucosal/buccal (b) pharmaceutical form of APAP dissolved in 50% wt alcohol is compared with other routes of administration. Two consecutive randomized, crossover, double-blind clinical trials (CT1: NCT00982215 and CT2: NCT01206985) included 16 healthy volunteers. CT1 compared the pharmacology of 250 mg bAPAP with 1 g iv APAP. CT2 compared the pharmacodynamics of 125 mg bAPAP with 1 g iv and 125 mg sublingual (s) APAP. Mechanical pain thresholds are recorded in response to mechanical stimuli applied on the forearm several times during 120 minutes. The objective is to compare the time of onset of antinociception and the antinociception (area under the curve) between the routes of administration with analysis of variance (significance P<0.05).ResultsbAPAP has a faster time of antinociception onset (15 minutes, P<0.01) and greater antinociception at 50 minutes (P<0.01, CT1) and 30 minutes (P<0.01, CT2) than ivAPAP and sAPAP. All routes are similar after 50 minutes.ConclusionbAPAP has a faster antinociceptive action in healthy volunteers. This attractive alternative to other routes would be useful in situations where oral or iv routes are not available. This finding must now be confirmed in patients suffering from acute pain of mild and moderate intensity.

Paracetamol in Older People: Towards Evidence-Based Dosing?

“…For drug-specific factors, limited research, especially on absorption, has been conducted on paracetamol when rectally administered in robust and frail older subjects. In addition, new routes of administration (buccal) are investigated, which should also be investigated in relation to the pharmacokinetics of oral and/or intravenous routes [ 53 , 54 ]. Concerning the patient-specific factors, the older patient population is very heterogeneous (e.g.…”

Topic delivery of analgesics in oral surgery

“…Finally, 3 studies reported the acceptance and the wellbeing of the patients using this strategy [7,10,12]. Even if a bitter taste has been mentioned, the patients are satisfied of the analgesia of the device but also of the comfort and the absence of repeated drug taking.…”

“…Unfortunately, no pain relief monitoring has been done. The last study, realized by Pickering et al in 2014, was based on the use of a hydroalcoolic solution of paracetamol and compared to intravenous and sublingual administration [12]. The results demonstrate a higher and faster analgesia compared to the controls.…”

“…Only 3 studies evaluating the pharmacokinetics properties have been selected. Usually, the doses of analgesics administered by locally are lower than the doses of analgesics per os [10][11][12]. Therefore, it is difficult to compare the plasmatic concentrations.…”

Pain Management of Pediatric Musculoskeletal Injury in the Emergency Department: A Systematic Review

“…The PRISMA Study Flow Diagram ( Figure 1 ) shows the flow of studies for this review. Of the 34 studies of potential relevance identified, 26 were excluded: nine were not randomized controlled trials [ 16 , 19 – 26 ]; one was an adult-only study [ 27 ]; one included only two children over a total of 67 patients with no specific pediatric data available [ 28 ]; one was concerned with fracture reduction [ 29 ]; one was conducted with healthy volunteers [ 30 ]; six had data collected at the participant's home after discharge from the ED [ 31 – 36 ]. The remaining seven studies were excluded despite adequate methodology, because we were unable to obtain the raw data necessary to calculate their risk ratio, despite multiple efforts to obtain this information from the authors [ 37 – 43 ].…”