This calculation in effect produces a measure of average pain intensity over the study period. The AUC was divided by the period of the completed assessments to adjust for the fact that some patients recorded pain for shorter periods than others. The primary outcome measure was the area under the curve (AUC) of these VAS ratings divided by time, at rest and on activity. The study nurse maintained contact with participants by telephone to facilitate compliance with data collection and the return of diaries. Ratings were requested at baseline (immediately before administration of the first dose of study medication) after operation (once the participants were sufficiently awake to respond) and 1–2 hourly thereafter, while awake, for 48 h. Participants were asked to rate their pain on 100 mm visual analogue scales (VAS), printed one per double page in a booklet that they took home.
ACETAMINOPHEN COD 3 CODE
Participants and investigators were blinded and the randomization code was not broken until the final database had been checked and locked. Only the statistician had access to the schedule of patient numbers by drug allocation. Stratification by anaesthetic type ensured a balance between treatments in terms of the number of teeth extracted, as most patients having more than two teeth extracted have a general anaesthetic. The randomization sequence was computer generated by the study statistician as a 1:1:1 allocation ratio to the three treatments in a sequence of permuted blocks with stratification for anaesthetic type (local or general) and study centre. If they consented, patients were then randomized into one of the three study groups in a sequential order to receive one of these formulations, in blinded packs. They were given written and verbal information about the study, and invited to participate. Patients were first approached by the surgeon and then by the study nurse. Tablets of identical appearance, packaging, and dosage instructions were provided in each of the following formulations: (i) acetaminophen 500 mg+ibuprofen 150 mg per tablet (Maxigesic ® Sigma Laboratories, Nashik, India which was MHRA approved for manufacturing pharmaceuticals under GMP) (ii) acetaminophen 500 mg per tablet or (iii) ibuprofen 150 mg per tablet. We have investigated the hypothesis that in adult patients undergoing a common surgical procedure (extraction of third molar teeth), this formulation provides superior analgesia to either of its components alone. Taking two tablets 6 hourly provides the appropriate daily dose of both drugs relatively simply.
Maxigesic ® is a new formulation of acetaminophen 500 mg and ibuprofen 150 mg. 15 A single formulation with a simplified regimen would probably be appreciated by patients and might improve compliance. 3 Compliance with the prescribed dosing regimen is important for achieving the desired result with any drug and is often poor with asynchronous dosing. Typically, acetaminophen is given in a dose regimen of 1 g 6 hourly whereas ibuprofen is given in a dose of 400 mg 8 hourly. 6, 8, 9, 11– 13 Ibuprofen has the advantage of a well-established safety record (particularly at doses below 1.5 g per day in adults), 14 and in many countries (including the UK), it is available without prescription. Prescribing acetaminophen and ibuprofen together is common in clinical practice. 4, 5 NSAIDs are often combined with acetaminophen, particularly for treating postoperative pain. Combining analgesics offers the possibility of increasing effectiveness without increasing dose (and therefore risk).
2 Acetaminophen is widely used and is very safe at the recommended dose of 4 g per day, 3 but does not always provide adequate pain relief on its own. Non-steroidal anti-inflammatory drugs (NSAIDs) have fewer regulatory restrictions, but they too have important adverse effects which are more likely at higher dose or with longer courses. 1 Opioid analgesics are effective, but have troublesome and potentially dangerous side-effects, and their potential for abuse may lead to regulatory and logistical difficulties.
The relief of pain has been described as a universal human right but is not always easily achieved.
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