R K Pandey1, S K Bahetwar, A K Saksena, Girish Chandra. 1. Department of Pedodontics and Preventive Dentistry, Faculty of Dental Sciences, C.S.M. Medical University, Lucknow, Uttar Pradesh, India.
Abstract
OBJECTIVE: The objective of this study was to compare and evaluate the efficacy and safety of drops and atomized administration of intranasal ketamine (INK) in terms of behavioral response for agent acceptance during administration and for agent efficacy and safety for the sedation of young uncooperative pediatric dental patients. STUDY DESIGN:Thirty-four uncooperative ASA grade-1 children, requiring dental treatment were randomly assigned to receive INK as drops and atomized spray in one of the subsequent visit. This was a two stage cross-over trial and each child received INK by both modes of administration. The vital signs were monitored continuously during each visit. RESULTS: A statistically significant difference in patients acceptance (P < 0.0001) was observed in the atomized administration when compared to drops administration for the procedural event of drug administration. Moreover there were also significant differences (P < 0.05) between onset of sedation and recovery time between two groups. All the vital signs were within normal physiological limits and there were no significant adverse effects in either group. CONCLUSIONS: INK is safe and effective by either mode of intranasal (IN) drug administration for moderate sedation in facilitating dental care for anxious and uncooperative pediatric dental patients. Moreover, INK when administered with the mucosal atomization device, the acceptance of the drug was associated with less aversive reaction, rapid onset and recovery of sedation, as compared to the drop administration of the same agent.
RCT Entities:
OBJECTIVE: The objective of this study was to compare and evaluate the efficacy and safety of drops and atomized administration of intranasal ketamine (INK) in terms of behavioral response for agent acceptance during administration and for agent efficacy and safety for the sedation of young uncooperative pediatric dental patients. STUDY DESIGN: Thirty-four uncooperative ASA grade-1 children, requiring dental treatment were randomly assigned to receive INK as drops and atomized spray in one of the subsequent visit. This was a two stage cross-over trial and each child received INK by both modes of administration. The vital signs were monitored continuously during each visit. RESULTS: A statistically significant difference in patients acceptance (P < 0.0001) was observed in the atomized administration when compared to drops administration for the procedural event of drug administration. Moreover there were also significant differences (P < 0.05) between onset of sedation and recovery time between two groups. All the vital signs were within normal physiological limits and there were no significant adverse effects in either group. CONCLUSIONS: INK is safe and effective by either mode of intranasal (IN) drug administration for moderate sedation in facilitating dental care for anxious and uncooperative pediatric dental patients. Moreover, INK when administered with the mucosal atomization device, the acceptance of the drug was associated with less aversive reaction, rapid onset and recovery of sedation, as compared to the drop administration of the same agent.
Authors: Thomas Cristoforo; Dulce Gonzalez; Mark Bender; Geraldine Uy; Linda Papa; Bertha A Ben Khallouq; Mark Clark; Brandon Carr; Kelly Cramm Journal: J Child Adolesc Trauma Date: 2021-09-13
Authors: James R Young; Hendry Robert Sawe; Juma A Mfinanga; Ernest Nshom; Ethan Helm; Charity G Moore; Michael S Runyon; Stacy L Reynolds Journal: BMJ Open Date: 2017-07-10 Impact factor: 2.692
Authors: Naveen Poonai; Kyle Canton; Samina Ali; Shawn Hendrikx; Amit Shah; Michael Miller; Gary Joubert; Michael Rieder; Lisa Hartling Journal: PLoS One Date: 2017-03-20 Impact factor: 3.240