British journal of clinical pharmacology
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Br J Clin Pharmacol · Dec 1996
Randomized Controlled Trial Comparative Study Clinical TrialCharacterization and validation of a pharmacokinetic model for controlled-release oxycodone.
1. Oxycodone is a strong opioid agonist that is currently available in immediate-release (IR) formulations for the treatment of moderate to severe pain. Recently, controlled-release (CR) oxycodone tablets were developed to provide the benefits of twice-a-day dosing to patients treated with oxycodone. ⋯ The mean prediction error was 2.7% with a coefficient of variation of 54%. 4. The absorption characteristics of CR oxycodone tablets should allow effective plasma concentrations of oxycodone to be reached quickly and for effective concentrations to be maintained for a longer period after dosing compared with the IR oral solution. The CR dosage form has pharmacokinetic characteristics that permit 12 hourly dosing.
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Br J Clin Pharmacol · Oct 1996
Randomized Controlled Trial Clinical TrialSelf-medication of a single headache episode with ketoprofen, ibuprofen or placebo, home-monitored with an electronic patient diary.
1. The objective of this study was to investigate the efficacy of home-medicated non-steroidal anti-inflammatory (NSAID) analgesics, using an electronic patient diary. Single doses of ketoprofen 25 mg and ketoprofen 50 mg were compared with ibuprofen 200 mg and placebo in the treatment of a single occasion of episodic tension-type headache, using a double-blind, randomized, parallel group design. 2. ⋯ Treatment of headache with ketoprofen can start with 25 mg, and possibly less. 6. Although a direct comparative study would be necessary to determine the relative benefits of the novel electronic patient diaries over traditional paper-and-pencil methods, this study has shown the usefulness of this newer technique to detect differences in efficacy between low doses of analgesics under ambulant conditions, with very limited loss of data. Electronic patient diaries appear to be an important new attribute for the efficacy assessment of self-medicated drugs.
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Br J Clin Pharmacol · Sep 1996
Randomized Controlled Trial Comparative Study Clinical TrialA randomized, double-blind, placebo-controlled trial comparing pethidine to metamizol for treatment of post-anaesthetic shivering.
1. Shivering is frequent during the post-anaesthetic recovery period, and there is no clear consensus about the best strategy for its treatment. We tested the efficacy of two commonly used analgesic drugs, pethidine and metamizol. 2. ⋯ Both drugs were well tolerated. 4. The persistence of shivering at 45 min in two thirds of placebo-treated patients indicates that drug treatment is worthwhile; metamizol produces a better postanaesthetic shivering response than placebo, especially 15 and 45 min after drug administration; the efficacy of pethidine was the highest and the response to it appeared more quickly; however, at 45 min it was similar to that observed with metamizol. 5. Both metamizol and pethidine suppress postanaesthetic shivering, but the latter induces a quicker and more reliable response.
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Br J Clin Pharmacol · Aug 1996
Randomized Controlled Trial Comparative Study Clinical Trial Controlled Clinical TrialClonidine and or adrenaline decrease lignocaine plasma peak concentration after epidural injection.
Clonidine is an alpha 2-adrenoceptor agonist increasingly used in combination with lignocaine for spinal or epidural anaesthesia because of a prolonged analgesic effect. Life adrenaline, it may decrease lignocaine peak concentration (Cmax), thus leading to decreased toxicity. ⋯ Total body clearance and apparent volume of distribution were similar in the four groups, but the maximum observed concentration (Cmax) was markedly increased in the plain solution group as compared with the other groups; (plain lignocaine: 7.15 +/- 2.04 micrograms ml-1, lignocaine + adrenaline: 3.11 +/- 136 micrograms ml-1, lignocaine + clonidine: 4.48 +/- 1.26 micrograms ml-1, lignocaine + adrenaline + clonidine: 4.06 +/- 1.42 micrograms ml-1 [mean +/- s.d.]). Our results show that, clonidine decreases lignocaine Cmax to the same extent as adrenaline.
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Br J Clin Pharmacol · Jun 1996
Randomized Controlled Trial Clinical TrialThe efficacy of ketoprofen and paracetamol (acetaminophen) in postoperative pain after third molar surgery.
1. A placebo-controlled, double-blind, randomized trial was carried out to evaluate the efficacy of single doses of racemic ketoprofen 12.5 and 25 mg and paracetamol 500 and 1000 mg in patients with post-operative pain after third molar surgery over a 6 h investigation period. 2. Outcome variables included overall pain scores (AUC(0,360 min), maximum pain relief, pain relief at 1 h after dosage and the number of patients taking escape analgesics. 3. ⋯ At 1 h after dosage, pain scores were significantly less (P < 0.01) after both doses of ketoprofen when compared with placebo. 6. Single doses of ketoprofen 12.5 and 25 mg, together with paracetamol 1000 mg are effective analgesics for treating post-operative pain after third molar surgery. These treatments provide up to 4 h of pain relief after this surgical procedure.