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A double-blind randomized controlled trial to compare the safety and efficacy of dexmedetomidine alone and in combination with ketamine in uncooperative and anxious paediatric dental patients requiring pulpectomy

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European Archives of Paediatric Dentistry Aims and scope Submit manuscript

Abstract

Aim

To compare the sedation regimen Dexmedetomidine alone and its combination with low dose Ketamine through intravenous route in terms of safety, efficacy and recovery profile in uncooperative paediatric dental patients requiring pulpectomy.

Material and methods

Thirty anxious and uncooperative 2–6-year-old children requiring pulpectomy in at least one primary molar were enrolled. Propofol was used as an induction agent. Drugs were administered through the intravenous route as per group assignment, i.e., Dexmedetomidine (1 µg/kg) with ketamine (0.5 mg/kg) administered over 10 min followed by a maintenance dose of Dexmedetomidine (0.2–0.8 µg/kg/h) in group A and Dexmedetomidine (1 µg/kg) administered over 10 min followed by a maintenance dose in group B. The sedation was titrated to achieve Houpt’s overall behavior score of 4/5. The primary outcome measure was the successful completion of treatment. Secondary outcome measures were vital signs, quality of sedation, time need for the procedure, recovery time, intra-operative and post-operative adverse sequelae.

Results

Results showed that both of the regimens were similar in efficacy, safety and recovery profile. Also, the required dose of dexmedetomidine and the need for rescue boluses was similar in both of the study groups.

Conclusion

Dexmedetomidine either alone or in combination with ketamine proved to be a safe and efficacious agent for paediatric dental sedation. No beneficial evidence of adding ketamine was observed.

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Data availability

Yes.

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References

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Acknowledgements

The authors are thankful to former Dean, Dr Manoj Goyal for his support and to the children and parents for participating in this study. The authors are thankful to Mr. Ramesh Goyal for conducting the statistical analysis.

Funding

None.

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Authors and Affiliations

Authors

Contributions

NM, BS, NG conceived the idea and concept. KH collected the data and did clinical cases. NM analyzed the data and prepared first draft. All authors gave their inputs, helped in revising and finalizing the manuscript.

Corresponding author

Correspondence to N. Mittal.

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Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

The study was approved by the Institutional ethical committee and review board.

Consent to participate and publication

Parents/caregivers of all participants signed an informed consent to provide their consent to participate in the study and give permission to disseminate the data.

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Haider, K., Mittal, N., Srivastava, B. et al. A double-blind randomized controlled trial to compare the safety and efficacy of dexmedetomidine alone and in combination with ketamine in uncooperative and anxious paediatric dental patients requiring pulpectomy. Eur Arch Paediatr Dent 23, 465–473 (2022). https://doi.org/10.1007/s40368-022-00706-w

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  • DOI: https://doi.org/10.1007/s40368-022-00706-w

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