Sevoflurane Associated With Oral Midazolam and Ketamine for Dental Sedation

NCT02284204 | Completed Phase 2

• 1 other identifier: MKSevadversos
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

There is still extensive debate on the best method of controlling the behavior of preschool children during dental treatment. Protective stabilization, moderate sedation and general anesthesia are advanced behavior control techniques indicated for the dental treatment of early childhood caries and offer advantages and disadvantages during the procedure or immediately after. Many children with early childhood caries require invasive dental treatment. According to the final report of a large epidemiological survey on the oral condition of Brazilians, five-year-old children had an average of 2.43 primary teeth with caries and fewer than 20% of these had been treated in 2010. This disease also remains a public health problem in most developed countries; 19.5% of 2-5-year-old American children have untreated cavities. There is, however, a lack of the ideal sedative. Such drugs must, on the one hand, control the behavior of integral form, provide amnesia, minimizing physical discomfort, distress and pain, and, on the other, safeguard security, with minimal effect on the cardio-respiratory function, minimizing the occurrence of adverse events, as well as allowing the return of the patient to a State that allows high safely. The investigators thus performed this prospective study with the aim to assess the occurrence of adverse events during dental treatment and in the first 24 hours after sedation with midazolam, ketamine and sevoflurane in children aged four to six years. Our hypothesis was that no differences in adverse events among different association of drugs could be found.

Conditions

Dental Anxiety

Outcome Measures

Primary Outcomes (1)

• adverse events

  Evaluate the occurrence of adverse events during restorative dental treatment and in the first 24 hours after sedation with midazolam, ketamine and sevoflurane in children four to six years.

  in the first 24 hours after sedation for dental treatment

Secondary Outcomes (1)

• Behavioral Control

  Houpt scores were established every minute of the dental treatment (estimated in 60 minutes), and in three specific moments (at the local anesthesia, at the use of high rotation and at the end of treatment), in addition to an overall evaluation

Study Arms (2)

Midazolam and Ketamine

ACTIVE COMPARATOR

In this arm, the children received, orally, the combination of midazolam and ketamine. Midazolam, at a dose of 0.5 mg/kg (maximum dose 20 mg) and ketamine, at a dose of 3 mg/kg (maximum dose 50 mg). This combination of drugs were administered fifteen minutes before the start of treatment sessions.

Drug: Midazolam and Ketamine

Midazolam, Ketamine and Sevoflurane

EXPERIMENTAL

In this arm, the children received, orally, the combination of midazolam and ketamine. Midazolam, at a dose of 0.5 mg/kg (maximum dose 20 mg) and ketamine, at a dose of 3 mg/kg (maximum dose 50 mg). After fifteen minutes of this drug administration, the investigators start to provide sevoflurane, through a nasal hood, in an initial concentration of 0.1%, with 0.1% increment every 30 seconds, until a final expired concentration between 0.3 and 0.4%.

Drug: Midazolam, Ketamine and Sevoflurane

Interventions

Midazolam, Ketamine and Sevoflurane DRUG

The combination of these three drugs were administered for the children of the intervention group in a attempt to improve the behavioral control. Midazolam and ketamine orally, sevoflurane inhaled.

Also known as: Midazolam, Dormire ® (Cristalia Lab, Sao Paulo, Brazil), Ketamine, Ketamin ® (Cristalia Lab, Sao Paulo, Brazil), Sevoflurane, Sevocris ® (Cristalia Lab, Sao Paulo, Brazil)

Midazolam, Ketamine and Sevoflurane

Midazolam and Ketamine DRUG

The combination of these two drugs were administered orally for the children of the control group.

Also known as: Midazolam, Dormire ® (Cristalia Lab, Sao Paulo, Brazil), Ketamine, Ketamin ® (Cristalia Lab, Sao Paulo, Brazil)

Midazolam and Ketamine

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children ASA I or II;
• Need for restorative procedure on at least one deciduous tooth below;
• Airway patent and effective nasal breathing;
• Behavior not collaborator in previous dental treatment.

You may not qualify if:

• Previous experience of dental treatment under sedation;
• Have completed seven years during the data collection.

Sponsors & Collaborators

• Universidade Federal de Goias: lead

Study Sites (1)

Faculty of Dentistry

Goiânia, Goiás, Brazil

Location

Related Publications (11)

• Dresser S, Melnyk BM. The effectiveness of conscious sedation on anxiety, pain, and procedural complications in young children. Pediatr Nurs. 2003 Jul-Aug;29(4):320-3. No abstract available.

  PMID: 12956555 BACKGROUND

• Cagiran E, Eyigor C, Sipahi A, Koca H, Balcioglu T, Uyar M. Comparison of oral Midazolam and Midazolam-Ketamine as sedative agents in paediatric dentistry. Eur J Paediatr Dent. 2010 Mar;11(1):19-22.

  PMID: 20359276 BACKGROUND

• Lourenco-Matharu L, Ashley PF, Furness S. Sedation of children undergoing dental treatment. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD003877. doi: 10.1002/14651858.CD003877.pub4.

  PMID: 22419289 BACKGROUND

• Hand D, Averley P, Lyne J, Girdler N. Advanced paediatric conscious sedation: an alternative to dental general anaesthetic in the U.K. SAAD Dig. 2011 Jan;27:24-9.

  PMID: 21323033 BACKGROUND

• American Academy of Pediatric Dentistry (AAPD). Guideline on Behavior Guidance for the Pediatric Dental Patient. Reference Manual 2013-2014, 35(6): 175-187.

  BACKGROUND

• The use of physical restraint interventions for children and adolescents in the acute care setting. American Academy of Pediatrics Committee on Pediatric Emergency Medicine. Pediatrics. 1997 Mar;99(3):497-8. doi: 10.1542/peds.99.3.497.

  PMID: 9041311 BACKGROUND

• Heard C, Smith J, Creighton P, Joshi P, Feldman D, Lerman J. A comparison of four sedation techniques for pediatric dental surgery. Paediatr Anaesth. 2010 Oct;20(10):924-30. doi: 10.1111/j.1460-9592.2010.03402.x.

  PMID: 20849497 BACKGROUND

• Lourenco-Matharu L, Roberts GJ. Oral sedation for dental treatment in young children in a hospital setting. Br Dent J. 2010 Oct 9;209(7):E12. doi: 10.1038/sj.bdj.2010.886. Epub 2010 Oct 1.

  PMID: 20885413 BACKGROUND

• Wilson S, Nathan JE. A survey study of sedation training in advanced pediatric dentistry programs: thoughts of program directors and students. Pediatr Dent. 2011 Jul-Aug;33(4):353-60.

  PMID: 21903005 BACKGROUND

• Wood M. The safety and efficacy of intranasal midazolam sedation combined with inhalation sedation with nitrous oxide and oxygen in paediatric dental patients as an alternative to general anaesthesia. SAAD Dig. 2010 Jan;26:12-22.

  PMID: 20151606 BACKGROUND

• Gomes HS, Gomes HS, Sado-Filho J, Costa LR, Costa PS. Does sevoflurane add to outpatient procedural sedation in children? A randomised clinical trial. BMC Pediatr. 2017 Mar 24;17(1):86. doi: 10.1186/s12887-017-0838-4.

  PMID: 28340572 DERIVED

Related Links

• Used for create the randomization plan.
• A large epidemiological survey on the oral status of the Brazilian population. Developed by the Department of Primary Health Care of the Ministry of Health in 2010.

MeSH Terms

Interventions

Midazolam; Ketamine; Sevoflurane

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Paulo S Costa, PhD

  Universidade Federal de Goias

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Health Sciences Graduate Program, Federal University of Goias (UFG), Goiania, Goias, Brazil

Study Record Dates

• First Submitted: October 5, 2014
• First Posted: November 5, 2014
• Study Start: January 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 11, 2017

Record last verified: 2017-01

Locations

BR (1)