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A Double Blind Randomized Trial of Ketofol Versus Propofol for Endodontic Treatment of Anxious Pediatric Patients

  • Mittal N1,*,
  • Goyal A2
  • Gauba K2
  • Kapur A2
  • Jain K2

1Department of Pedodontics and Preventive Dentistry, Santosh Dental College and Hospital, Ghaziabad, Uttar Pradesh, India

2Department of Anesthesia and Intensive Care in PGIMER, Chandigarh, India.

DOI: 10.17796/jcpd.37.4.thv8372410714342 Vol.37,Issue 4,July 2013 pp.415-420

Published: 01 July 2013

*Corresponding Author(s): Mittal N E-mail:


To find out the safe and efficient sedative agent for primary molar pulpectomy in uncooperative pediatric patients. Study Design: This double blind randomized trial enrolled 40 anxious and healthy 2-6 year olds. All subjects received IV propofol (1-1.5mg/kg) or ketofol (1-1.5 mg/kg propofol with 0.25mg/kg ketamine) as per group assignment after oral midazolam premedication (0.5 mg/kg). Sedation maintenance was done with propofol infusion at 25-75µg/kg/min titrated to a predefined Worse level as per Houpt’s sedation rating scale. Additional bolus/es was/were administered in the dosage similar to induction dose in case of inadequate sedation. Primary outcomes were intraoperative and postoperative adverse events. Secondary outcomes were vital signs, success of procedure, operator satisfaction, sedation quality, treatment time, recovery time and total propofol dose. Results: Significantly greater incidence of respiratory depression was reported for ketofol group (11/20; 55%) when compared to propofol group (3/20; 15%) (p = 0.008). Desaturation was the most common adverse respiratory event with significantly greater incidence in ketofol group (9/20; 45%) when compared to propofol only group (3/20; 15%) (p = 0.033). No significant differences regarding secondary outcomes were reported in two groups. Conclusion: Both the regimen exhibited similar sedation profile while propofol alone emerged as a safer option.


Anxiety, Behavior management, Sedation, Propofol, Ketamine, Ketofol

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Mittal N,Goyal A, Gauba K,Kapur A, Jain K. A Double Blind Randomized Trial of Ketofol Versus Propofol for Endodontic Treatment of Anxious Pediatric Patients. Journal of Clinical Pediatric Dentistry. 2013. 37(4);415-420.


1. Weinstein P, Nathan JE. The challenges of fearful and phobic children. Dent Clin North Am 32: 667-92, 1988.

2. Hallonsten AL. Nitrous oxide oxygen sedation in dentistry. Swed Dent J suppl 14: 9-10, 1982.

3. Veerkamp JSJ, Van Amerongen WE, Hoogstrten J, Groen HJ. Dental treatment of fearful children using nitrous oxide. Part I: Treatment Times. J Dent Child 6: 453-7, 1991.

4. Veerkamp JSJ, Gruthuysen RJM, Van Amerongen WE, Hoogstrten J. Dental treatment of fearful children using nitrous oxide. Part III : Anxiety during sequential visits. J Dent Child 3: 175-82, 1993.

5. Houpt MI, Sheskin RB, Koenigsberg SR, Desjardins PJ, Shey Z. Assessing chloral hydrate dosage for young children. J Dent Child 52: 364-369, 1985.

6. Gladney, Stanley RT, Hendricks SE. Anxiolytic activity of chloral hydrate and hydroxyzine. Ped Dent 16: 183-7, 1994.

7. Davila JM, Herman AE, Proskin HM, Vitale D. Comparison of sedative effectiveness of two pharmacological regimens. J Dent Child 61:276-281, 1994.

8. Nathan JE, West MS. Comparison of chloral hydrate- hydroxizine with and without meperidine for management of difficult pediatric patients. J Dent Child 54: 437-443, 1987.

9. Sams DR, Thorton JB, Wright JM. The assessment of two oral sedation drug regimens in pediatric dental patients. J Dent Child 59: 306-312, 1992.

10. Littman RS, Kotra JA, Verga RA, Berkowitz RJ, Ward DS. Chloral hydrate sedation. The additive sedative and respiratory depressant effect of nitrous oxide. Anesth Analg 86: 724-728, 1998.

11. Haney KL, McWhorter AG, Scale NS. An assessment of success of meperidine and promethazine sedation in medically compromised children. J Dent Child 60: s 288-295, 1993.

12. Bui T, Redden JR, Murphy S. A comparison study between ketamine and ketamine-promethazine combination for oral sedation in pediatric dental patients. Anesth Prog 49:14-18, 2002.

13. Roelofse AJ, Joubert VDJJ, Roelofse RGP. A Double-Blind Randomized Comparison of Midazolam Alone and Midazolam Combined With Ketamine for Sedation of Pediatric Dental Patients. J Oral Maxillofac Surg 54: 238-844, 1996.

14. Arya VS, Damle SG. Comparative evaluation of Midazolam and Propofol as intravenous sedative agents in the management of unco-operative children. J Indian Soc Pedod Prev Dent 20:6-8, 2002.

15. Hosey TM, Makin A, Jones MR, Gilchris F, Carruthers M. Propofol intravenous conscious sedation for anxious children in a specialist paediatric dentistry unit. Int J Paediatr Dent 14: 2–8, 2004.

16. Rai K, Hegde M A, Goel K. Sedation in uncooperative children undergoing dental procedures: a comparative evaluation of midazolam, propofol and ketamine. J Clin Pediatr Dent 32:1-4, 2007.

17. Kapur A, Chawla SH, Goyal A, Gauba K, Bhardwaj N. Efficacy and acceptabilty of oral-transmucosal midazolam as a conscious sedation agent in pre-school children. J Indian Soc Pedod Prev Dent 22:109-13, 2004

18. Bryson MH , Fulton RB, Faulds D. Propofol an update of its use in anesthesia and conscious sedation. Drugs 50:513-59, 1995.

19. Tomatir E, Atalay H, Gurses E, Erbay H, Bozkurt P. Effects of low dose ketamine before induction on propofol anesthesia for pediatric magnetic resonance imaging. Paediatr Anaesth 14:845-850, 2004.

20. Akin A, Esmaoglu A, Tosun Z, Gulcu N, Aydogan H, Boyaci A. Comparison of propofol with propofol-ketamine combination in pediatric patients undergoing auditory brainstem response testing. Int J Pediatr Otorhinolaryngol 69:1541-1545, 2005.

21. Venham L. The effect of mother’s presence on child’s response to dental treatment. J Dent Child 46:219-225, 1979.

22. Houpt M. Project USAP the use of sedative agents in dentistry. Pediatr Dent 15: 36-40, 1993.

23. Singh R, Batra KY, Bhari, Panda BN. Comparison of propofol versus propofol-ketamine combination for sedation during spinal anesthesia in children: randomized clinical trial of efficacy and safety. Pediatr Anesth 20: 439–444, 2010.

24. David H, Shipp J. A randomized controlled trial of Ketamine/Propofol versus Propofol alone for emergency department procedural sedation. Ann Emer Med 57: 435-42, 2011.

25. Aroni F, Iacovidou N, Dontas I, Pourzitaki C and Xanthos T. Pharmacological Aspects and Potential New Clinical Applications of Ketamine: Reevaluation of an Old Drug. J Clin Pharmacol 49: 957-63, 2009.

26. Daabiss M, Elsherbiny M, Al Otibi R. Assessment of different concentrations of Ketofol in procedural sedation. Br J Med Pr 552: 27-31, 2009.

27. Green MS, Roback GM, Krauss B. Anticholinergics and Ketamine Sedation in Children: A Secondary Analysis of Atropine Versus Glycopyrrolate. Acad Emerg Med 17:157–162, 2010.

28. Messenger WD, Murray EH, Dungey EP, Sivilotti ALM. Subdissociative-dose Ketamine versus Fentanyl for Analgesia during Propofol Procedural Sedation: A Randomized Clinical Trial. Acad Emerg Med 15:877– 886, 2008.

29. Struys MM, Coppens MJ, De Neve N, Mortier EP, Doufas AG, Van Bocxlaer JF, Shafer SL. Influence of administration rate on propofol plasma-effect site equilibration. Anesthesiology 107:386–96, 2007.

30. Tosun Z, Aksu R, Guler G, Esmaoglu A, Akin A, Aslan E, Boyaci A. Propofol-ketamine vs propofol-fentanyl for sedation during pediatric upper gastrointestinal endoscopy. Pediatric Anesthesia 17: 983–988, 2007.

31. Berkenbosch JW, Fichter CR, Tobias JD. The correlation of the bispectral index monitor with clinical sedation scores during mechanical ventilation in the pediatric intensive care unit. Anesth Analg 94:506–511, 2002.

32. Powers KS, Nazarian EB, Tapyrik SA, Kohli MS, Yin H, van der Jagt WE, Sullivan SJ, Rubenstein SJ. Bispectral index as a guide for titration of propofol during procedural sedation among children. Pediatrics 115:1666– 1674, 2005.

33. Grindstaff RJ, Tobias JD. Applications of bispectral index monitoring in the pediatric intensive care unit. J Intensive Care Med 19:111–116, 2004.

34. Dahaba AA. Different conditions that could result in the bispectral index indicating an incorrect hypnotic state. Anesth Analg 101:765–773, 2005.

35. Sakai T, Singh H, Mi WD, Kudo T, Matsuki A. The effect of ketamine on clinical endpoints of hypnosis and EEG variables during propofol infusion. Acta Anaesthesiol Scand 43: 212–216, 1999;

36. Vereecke HE, Struys MM, Mortier EP. A comparison of bispectral index and ARX-derived auditory evoked potential index in measuring the clinical interaction between ketamine and propofol anaesthesia. Anaesthesia 58: 957–961, 2003.

37. Hans P, Dewandre PY, Brichant JF, Bonhomme V. Comparative effects of ketamine on Bispectral Index and spectral entropy of the electroencephalogram under sevoflurane anaesthesia. Br J Anaesth 94:336–340, 2005.

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