OBJECTIVE:Procedural sedation and analgesia (PSA) has reduced the need for general anesthesia (GA) for many surgical procedures in pediatric patients. The objective of this study was to evaluate the efficacy of four analgo-sedative combinations- midazolam plus ketamine (MK), midazolam plus tramadol (MT), promethazine plus tramadol (PT) and promethazine plus ketamine (PK) in facilitating dental treatment of uncooperative children. STUDY DESIGN:Thirty six uncooperative ASA type I children who required extensive dental treatment were randomly assigned to receive one of the four analgo-sedative combinations during each visit. A 4-stage cross-over design was adopted so that each child received all the four combinations. Safety was monitored through vital signs and side effects. RESULTS: The overall success was 81% with MK, 69% for PK, 67% for MT and 42% for PT and the difference between the success rates of these agents was statistically significant (p < 0.001). The required dental treatment could be successfully completed at least during 3 sessions in 23 children (62.2%). CONCLUSIONS: Segmental dental treatment under analgo-sedation can be considered as a viable alternative before considering patients for dental management under GA. MK and MT were found to be safe and effective for sedating pediatric dental patients.
RCT Entities:
OBJECTIVE: Procedural sedation and analgesia (PSA) has reduced the need for general anesthesia (GA) for many surgical procedures in pediatric patients. The objective of this study was to evaluate the efficacy of four analgo-sedative combinations- midazolam plus ketamine (MK), midazolam plus tramadol (MT), promethazine plus tramadol (PT) and promethazine plus ketamine (PK) in facilitating dental treatment of uncooperative children. STUDY DESIGN: Thirty six uncooperative ASA type I children who required extensive dental treatment were randomly assigned to receive one of the four analgo-sedative combinations during each visit. A 4-stage cross-over design was adopted so that each child received all the four combinations. Safety was monitored through vital signs and side effects. RESULTS: The overall success was 81% with MK, 69% for PK, 67% for MT and 42% for PT and the difference between the success rates of these agents was statistically significant (p < 0.001). The required dental treatment could be successfully completed at least during 3 sessions in 23 children (62.2%). CONCLUSIONS: Segmental dental treatment under analgo-sedation can be considered as a viable alternative before considering patients for dental management under GA. MK and MT were found to be safe and effective for sedating pediatric dental patients.