Comparative study of safety and efficacy of Fentanyl and Midazolam combination with Ketamine and Midazolam combination for procedural sedation in pediatric patients
Abstract
Introduction: Study was planned to compare the safety and efficacy of Fentanyl and Midazolam combination with Ketamine and Midazolam combination for “procedural sedation” in pediatric patients.
Methodology: Sixty ASA1and 2 pediatric patients satisfying inclusion criteria were included in the study. These patients were enrolled by convenience sampling. They were randomized to receive ketamine or midazolam/fentanyl. Both the groups were comparable with respect to age, sex and body weight and proposed procedures. Hemodynamic and respiratory changes occurring during sedation, surgical procedure and during recovery, after administration of the test drug were studied. Measures used for efficacy of drug, that is quantification of distress, pain, anxiety, sedation and complications were also evaluated.
Results: On Comparison of age, gender, weight at different time intervals of cases between both groups were comparable with respect to age and weight of patients. On comparison of Pulse Rate at different time intervals of cases between K/M and F/M groups. The mean value of Pulse Rate in K/M and F/M groups is statistically significant (p<0.05) only at 5 and 10 minutes after sedation. Comparison of Mean Duration of Procedure and Recovery of cases between K/M and F/M groups shows statistically non-significant difference (p<0.05) in duration of procedures, and statistically significant difference (p<0.05) in duration of recovery. Comparison of complication rate of cases between K/M and F/M groups is statistically non-significant (p<0.05).
Conclusion: We concluded that both the drugs were safe to use in pediatric patients in the doses used intravenous. Ketamine / Midazolam regimen is more effective than the intravenous Fentanyl / Midazolam regimen for relief of pain and anxiety in children, resulting in lesser distress scores.
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References
2. Broennle AM, Cohen DE. Paediatric anesthesia and sedation. Curr Opin Pediatr. 1993 Jun;5(3):310-4. [PubMed]
3. Friedman AG, Mulhern RK, Fairclough D et al. Midazolam premedication for pediatric bone marrow aspiration and lumbar puncture. Med Pediatr Oncol. 1991;19(6):499-504. [PubMed]
4. Ramsay MAE, SavegeTM, Simpson BRJ and Goodwin R. Controlled sedation with alpaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. [PubMed]
5. Kennedy RM, Porter FL, Miller JP et al. Comparison of fentanyl/midazolam with ketamine/midazolam for paediatric orthopedic emergencies. Pediatrics. 1998 Oct;102(4 Pt 1):956-63. [PubMed]
6. Roback MG, Wathen JE, Bajaj L, Bothner JP. Adverse events associated with procedural sedation and analgesia in a pediatric emergency department: A comparison of common parenteral drugs. Acad Emerg Med. 2005 Jun;12(6):508-13.
7. Parker RI, Mahan RA, Giugliano D, and Parker M M : Efficacy and Safety of Intravenous Midazolam and Ketamine as Sedation for Therapeutic and Diagnostic Procedures in Children.: Pediatrics Vol. 99 No. 3 March 1997, pp. 427-431. [PubMed]
8. Godambe SA, , Elliot V, , Matheny D, Pershad J. Comparison of Propofol/Fentanyl Versus Ketamine/Midazolam for Brief Orthopedic Procedural Sedation in a Pediatric Emergency Department. Pediatrics 2003;112(1) July:116-123.
9. Slonim AD, Ognibene FP. Amnestic Agents in Pediatric Bronchoscopy. Chest. 1999 Dec;116(6):1802-8. [PubMed]
10. Ip U, Saincher A.. Safety of pediatric procedural sedation in a Canadian emergency department. CJEM. 2000 Jan;2(1):15-20. [PubMed]
11. Yldzdaş D, Yapcoglu H, Ylmaz HL. The value of capnography during sedation or sedation/analgesia in pediatric minor procedures. Pediatr Emerg Care. 2004 Mar;20(3):162-5. [PubMed]
12. Roback MG, Wathen JE, Bajaj L, Bothner JP. Adverse Events Associated with Procedural Sedation and Analgesia in a Pediatric Emergency Department: A Comparison of Common Parenteral Drugs. Academic Emergency Medicine Volume 12, Number 6 508-513. DOI: 10.1197/j.aem.2004.12.009.
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