Oral analgesic sedation of mentally handicapped patients – preliminary results

Česká verzia

Authors: Málek Jiří ¹; Hess Ladislav ²; Ščigel Vladimír ³; Fuksa Martin ⁴; Kurzová Alice ¹
Authors place of work: Klinika anesteziologie a resuscitace 3. LF UK a FNKV Praha ¹; Experimentální pracoviště IKEM Praha ²; Stomatologické pracoviště pro rizikové pacienty IKEM Praha ³; Klinika transplantační anesteziologie a intenzivní medicíny IKEM Praha ⁴
Published in the journal: Anest. intenziv. Med., 22, 2011, č. 4, s. 209-214
Category: Anesteziologie - Původní práce

Summary

Objective:
Patients who are uncooperative because of mental retardation present a challenge for the medical personnel. Intravenous or intramuscular administration of drugs is often difficult without restraint so the oral route seems to be the best option. The aim was to develop oral premedication for handling uncooperative adult patients in a dental care model.

Design:
Prospective randomised single blinded clinical study.

Setting:
A stomatology department of a research institute.

Material and methods:
After ethics committee approval and trustees’ consent, a flavoured drink with midazolam 0.3 mg . kg^-1 + clonidine 2 µg . kg^-1 + ketamine 5 mg . kg^-1 (Group Clo) or midazolam 0.3 mg . kg^-1 + ketamine 5 mg . kg^-1 (Group K) was offered to mentally handicapped patients scheduled for dental examination. The measured parameters included the onset of sedation enabling positioning the patient in the dental chair and securing venous access, vital signs (non-invasive blood pressure, pulse, SpO₂) and psychomotor recovery. All monitoring was non-invasive.

Results:
So far 17 patients in the Clo group and 8 patients in the K group have been included in the study. There were no differences in the demography and duration of treatment. All patients accepted the drink. Median time of the first signs of sedation was 10 minutes in the Clo group and 7 minutes in the K group, median onset time of full effect was 20 min in both groups. The level of sedation enabled stress-free peripheral vein cannulation in all patients and in 18 of 20 patients also dental treatment under local anaesthesia. Fractional administration of etomidate or propofol and/or ketamine was necessary in 2 patients. There was one case of deep sedation resulting in transitory loss of airway patency in each group and 3 cases of tachycardia in the K group vs. none in the Clo group (p < 0.05). Spontaneous recovery occurred at 105 min. in the Clo group and at 60 min. in the K group (median). Flumazenil IV was used in the remaining 8 patients in the Clo group and 3 in the K group. The onset of flumazenil effect was 1–2 min. There were 2 cases of resedation after flumazenil in the Clo group vs. 0 in the K group.

Conclusion:
Preliminary results indicate that oral premedication with clonidine, ketamine and midazolam combination produces good quality sedation and better cardiovascular stability compared to sedation without clonidine.

Keywords:
mental incapacity – oral premedication – analgesic sedation – ketamine – midazolam – clonidine – stomatology

Zdroje

1. Wong, A. Treatment planning considerations for adult oral rehabilitation cases in the operating room. Dent. Clin. North. Am., 2009, 53, p. 255–267.

2. Solomowitz, B. H. Treatment of mentally disabled patients with intravenous sedation in a dental clinic outpatient setting. Dent. Clin. North. Am., 2009, 53, p. 231–242.

3. Miyawaki, T., Kohjitani, A., Maeda, S. et al. Intravenous sedation for dental patients with intellectual disability. J. Intellect. Disabil. Res., 2004, 48, p. 764–768.

4. Vadivelu, N., Harkness, P., Richman, S., Shelley, K. H. Special anesthetic concerns in mentally handicapped institutionalized patients undergoing gynecological procedures in an outpatient setting. Conn. Med., 2004, 68, p. 359–362.

5. Fukuta, O., Braham, R. L., Yanase, H., Kurosu, K. The sedative effects of intranasal midazolam administration in the dental treatment of patients with mental disabilities. Part 2: optimal concentration of intranasal midazolam. J. Clin. Pediatr. Dent., 1994, 18, p. 259–265.

6. Rosenberg, M. Oral ketamine for deep sedation of difficult--to-manage children who are mentally handicapped: case report. Pediatr. Dent., 1991, 13, p. 221–223.

7. Neckel, W., Jacobs, F. E., Tolksdorf, W. Oral ketamine as preferred preanesthetic medication of uncooperative patients. Anasthesiol Intensivmed Notfallmed Schmerzther, 1992, 27, p. 381–384.

8. Cote, C. J., Cohen, I. T., Suresh, S. et al. A comparison of three doses of a commercially prepared oral midazolam syrup in children. Anesth. Analg., 2002, 94, p. 37–43, table of contents.

9. Amrein, R., Hetzel, W. Pharmacology of Dormicum (midazolam) and Anexate (flumazenil). Acta Anaesthesiol. Scand. Suppl., 1990, 92, p. 6–15; discussion p. 47.

10. Cortinas, M., Oya, B., Caparros, P., Cano, G., Ibarra, M., Martinez, L. Oral ketamine-midazolam premedication of uncooperative patients in major outpatient surgery. Rev. Esp. Anestesiol. Reanim., 2010, 57, p. 479–485.

11. Bergendahl, H., Lonnqvist, P. A., Eksborg, S. Clonidine in paediatric anaesthesia: review of the literature and comparison with benzodiazepines for premedication. Acta Anaesthesiol. Scand., 2006, 50, p. 135–143.

12. Funk, W., Jakob, W., Riedl, T., Taeger, K. Oral preanaesthetic medication for children: double-blind randomized study of a combination of midazolam and ketamine vs midazolam or ketamine alone. Br. J. Anaesth., 2000, 84, p. 335–340.

13. Grant, I. S., Nimmo, W. S., Clements, J. A. Pharmacokinetics and analgesic effects of i.m. and oral ketamine. Br. J. Anaesth., 1981, 53, p. 805–810.

14. Chong, C., Schug, S. A., Page-Sharp, M., Jenkins, B., Ilett, K. F. Development of a sublingual/oral formulation of ketamine for use in neuropathic pain: Preliminary findings from a three-way randomized, crossover study. Clin. Drug Investig., 2009, 29, p. 317–324.

15. Schwagmeier, R., Alincic, S., Striebel, H. W. Midazolam pharmacokinetics following intravenous and buccal administration. Br. J. Clin. Pharmacol., 1998, 46, p. 203–206.

16. Marshall, J., Rodarte, A., Blumer, J., Khoo, K. C., Akbari, B., Kearns, G. Pediatric pharmacodynamics of midazolam oral syrup. Pediatric Pharmacology Research Unit Network. J. Clin. Pharmacol., 2000, 40, p. 578–589.

17. Shapira, J., Holan, G., Botzer, E., Kupietzky, A., Tal, E., Fuks, A. B. The effectiveness of midazolam and hydroxyzine as sedative agents for young pediatric dental patients. ASDC J. Dent. Child, 1996, 63, p. 421–425.

18. Crevoisier, C., Ziegler, W. H., Eckert, M., Heizmann, P. Relationship between plasma concentration and effect of midazolam after oral and intravenous administration. Br. J. Clin. Pharmacol., 1983, 16, Suppl. 1, p. 51S–61S.

19. Levanen, J., Makela, M. L., Scheinin, H. Dexmedetomidine premedication attenuates ketamine-induced cardiostimulatory effects and postanesthetic delirium. Anesthesiology, 1995, 82, p. 1117–1125.

20. Miyawaki, T., Kohjitani, A., Maeda, S. et al. Intravenous sedation for dental patients with intellectual disability. J. Intellect. Disabil. Res., 2004, 48, p. 764–768.

21. Patsalos, P. N., Froscher, W., Pisani, F., van Rijn, C. M. The importance of drug interactions in epilepsy therapy. Epilepsia, 2002, 43, p. 365–385.

22. Salonen, M., Reid, K., Maze, M. Synergistic interaction between alpha 2-adrenergic agonists and benzodiazepines in rats. Anesthesiology, 1992, 76, p. 1004–1011.

23. Bozkurt, P. Premedication of the pediatric patient – anesthesia for the uncooperative child. Curr. Opin. Anaesthesiol., 2007, 20, p. 211–215.