Effective dose of nefopam in 80% of patients (ED80): A study using the continual reassessment method

British Journal of Clinical Pharmacology

Volumn 64, Issue 5, 2007, Pages 686-693

  Beloeil, Hélène ^b   Eurin, Mathilde ^b   Thévenin, Aude ^b   Benhamou, Dan ^b   Mazoit, Jean Xavier ^a  

^a BICÊTRE HOSPITAL   (France)

^b NONE

Author keywords

Continual reassessment method; Dose effect; Nefopam

Indexed keywords

DROPERIDOL; NEFOPAM; REMIFENTANIL; SUFENTANIL;

ADULT; ARTICLE; BLOOD PRESSURE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTINUAL REASSESSMENT METHOD; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIZZINESS; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EFFICACY; FEMALE; HUMAN; MALE; MEDICAL ASSESSMENT; NAUSEA; PAIN; POSTOPERATIVE PERIOD; PRIORITY JOURNAL; PROBABILITY; SIDE EFFECT; STATISTICAL ANALYSIS; SWEATING; TACHYCARDIA; VOMITING; XEROSTOMIA;

ADULT; ANALGESICS, NON-NARCOTIC; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; NEFOPAM; PAIN MEASUREMENT; PAIN, POSTOPERATIVE; PROSPECTIVE STUDIES; TREATMENT OUTCOME;

EID: 35248826890     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.0306-5251.2007.02960.x     Document Type: Article

References (27)

1. McLintock TT, Kenny GN, Howie JC, McArdle CS, Lawrie S, Aitken H. Assessment of the analgesic efficacy of nefopam hydrochloride after upper abdominal surgery: a study using patient controlled analgesia. Br J Surg 1988 75 : 779 81.
2. Mimoz O, Incagnoli P, Josse C, Gillon MC, Kuhlman L, Mirand A, Soilleux H, Fletcher D. Analgesic efficacy and safety of nefopam vs. propacetamol following hepatic resection. Anaesthesia 2001 56 : 520 5.
3. Du Manoir B, Aubrun F, Langlois M, Le Guern ME, Alquier C, Chauvin M, Fletcher D. Randomized prospective study of the analgesic effect of nefopam after orthopaedic surgery. Br J Anaesth 2003 91 : 836 41.
4. Piercey MF, Schroeder LA. Spinal and Supraspinal sites for morphine and nefopam analgesia in the mouse. Eur J Pharmacol 1981 74 : 135 40.
5. Rosland JH, Hole K. The effect of nefopam and its enantiomers on the uptake of 5-hydroxytryptamine, noradrenaline and dopamine in crude rat brain synaptosomal preparations. J Pharm Pharmacol 1990 42 : 437 8.
6. Beloeil H, Delage N, Negre I, Mazoit JX, Benhamou D. The median effective dose of nefopam and morphine administered intravenously for postoperative pain after minor surgery: a prospective randomized double-blinded isobolographic study of their analgesic action. Anesth Analg 2004 98 : 395 400.
7. Delage N, Maaliki H, Beloeil H, Benhamou D, Mazoit JX. Median effective dose (ED50) of nefopam and ketoprofen in postoperative patients: a study of interaction using sequential analysis and isobolographic analysis. Anesthesiology 2005 102 : 1211 6.
8. Dixon WJ. Staircase bioassay: the up-and-down method. Neurosci Biobehav Rev 1991 15 : 47 50.
9. Paul M, Fisher DM. Are estimates of MAC reliable? Anesthesiology 2001 95 : 1362 70.
10. Lu W, Ramsay JG, Bailey JM. Reliability of pharmacodynamic analysis by logistic regression: mixed-effects modeling. Anesthesiology 2003 99 : 1255 62.
11. O'Quigley J, Pepe M, Fisher L. Continual reassessment method: a practical design for phase 1 clinical trials in cancer. Biometrics 1990 46 : 33 48.
12. Kramar A, Lebecq A, Candalh E. Continual reassessment methods in phase I trials of the combination of two drugs in oncology. Stat Med 1999 18 : 1849 64.
13. Storer BE. An evaluation of phase I clinical trial designs in the continuous dose-response setting. Stat Med 2001 20 : 2399 408.
14. O'Quigley J, Shen LZ. Continual reassessment method: a likelihood approach. Biometrics 1996 52 : 673 84.
15. Whitehead J, Zhou Y, Stallard N, Todd S, Whitehead A. Learning from previous responses in phase I dose-escalation studies. Br J Clin Pharmacol 2001 52 : 1 7.
16. Fabre E, Chevret S, Piechaud JF, Rey E, Vauzelle-Kervoedan F, D'Athis P, Olive G, Pons G. An approach for dose finding of drugs in infants: sedation by midazolam studied using the continual reassessment method. Br J Clin Pharmacol 1998 46 : 395 401.
17. Desfrere L, Zohar S, Morville P, Brunhes A, Chevret S, Pons G, Moriette G, Rey E, Treluyer JM. Dose-finding study of ibuprofen in patent ductus arteriosus using the continual reassessment method. J Clin Pharm Ther 2005 30 : 121 32.
18. Dougherty TB, Porche VH, Thall PF. Maximum tolerated dose of nalmefene in patients receiving epidural fentanyl and dilute bupivacaine for postoperative analgesia. Anesthesiology 2000 92 : 1010 6.
19. Dihle A, Helseth S, Paul SM, Miaskowski C. The exploration of the establishment of cutpoints to categorize the severity of acute postoperative pain. Clin J Pain 2006 22 : 617 24.
20. Venables WN, Ripley BD. Modern Applied Statistics with S-PLUS. Statistics and Computing Series 3rd edn. New York, Springer-Verlag, 1999.
21. Zohar S, Latouche A, Taconnet M, Chevret S. Software to compute and conduct sequential Bayesian phase I or II dose-ranging clinical trials with stopping rules. Comput Meth Programs Biomed 2003 72 : 117 25.
22. Zohar S, Chevret S. The continual reassessment method. comparison of Bayesian stopping rules for dose-ranging studies. Stat Med 2001 20 : 2827 43.
23. Sunshine A, Laska E. Nefopam and morphine in man. Clin Pharmacol Ther 1975 18 : 530 4.
24. Tigerstedt I, Sipponen J, Tammisto T, Turunen M. Comparison of nefopam and pethidine in postoperative pain. Br J Anaesth 1977 49 : 1133 8.
25. Tigerstedt I, Tammisto T, Leander P. Comparison of the analgesic dose-effect relationships of nefopam and oxycodone in postoperative pain. Acta Anaesthesiol Scand 1979 23 : 555 60.
26. Scherpereel P. Utilisation pratique des analgésiques non morphiniques dans le traitement de la douleur aiguë postopératoire. Ann Fr Anesth Réanim 1985 4 : 446 50.
27. Phillips G, Vickers MD. Nefopam in postoperative pain. Br J Anaesth 1979 51 : 961 5.