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Year : 2017  |  Volume : 35  |  Issue : 2  |  Page : 156-161

Evaluation of nitrous oxide-oxygen and triclofos sodium as conscious sedative agents

1 Department of Pedodontics and Preventive Dentistry, The Oxford Dental College, Hospital and Research Centre, Bengaluru, Karnataka, India
2 Department of Dentistry, Hassan Institute of Medical Sciences, Hassan, Karnataka, India

Date of Web Publication10-May-2017

Correspondence Address:
Priya Subramaniam
Department of Pedodontics and Preventive Dentistry, The Oxford Dental College, Hospital and Research Centre, Bommanahalli, Hosur Road, Bengaluru - 560 068, Karnataka
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/JISPPD.JISPPD_82_16

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Background: Conscious sedation is used in the pediatric dentistry to reduce fear and anxiety in children and promote favorable treatment outcomes. To achieve them, the primary clinical need is for a well-tolerated, effective, and expedient analgesic and sedative agent that is safe to use. Aim: The aim of the present study was to evaluate the efficacy of nitrous oxide-oxygen and triclofos sodium as conscious sedative agents in 5–10-year-old children. Methodology: Sixty children aged 5–10 years showing anxious, uncooperative, and apprehensive behavior were randomly divided and assigned into two groups (Groups A and B) such that Group A received 40% nitrous oxide-60% oxygen and Group B received triclofos sodium in the dose of 70 mg/kg body weight, given 30 min before the treatment procedure. During the whole course of sedation procedure, the response of the child was assessed using Houpt's behavior rating scale. The acceptance of route of drug administration by the patient and parent was also assessed. Data obtained were statistically evaluated using the Mann–Whitney U-test and Chi-square test. Results: Children sedated with triclofos sodium were significantly more drowsy and disoriented compared to those sedated with nitrous oxide. The overall behavior of children in both the groups was similar. Good parental acceptance was observed for both the routes of administration. Patients accepted the oral route significantly better than inhalation route. Conclusion: Both nitrous oxide-oxygen and triclofos sodium were observed to be effective sedative agents, for successful and safe use in 5–10-year-old dental patients. Patients showed a good acceptance of the oral route compared to the inhalation route for sedation.

Keywords: Inhalation route, nitrous oxide-oxygen, oral sedation, patient acceptance, triclofos sodium

How to cite this article:
Subramaniam P, Girish Babu K L, Lakhotia D. Evaluation of nitrous oxide-oxygen and triclofos sodium as conscious sedative agents. J Indian Soc Pedod Prev Dent 2017;35:156-61

How to cite this URL:
Subramaniam P, Girish Babu K L, Lakhotia D. Evaluation of nitrous oxide-oxygen and triclofos sodium as conscious sedative agents. J Indian Soc Pedod Prev Dent [serial online] 2017 [cited 2022 Aug 17];35:156-61. Available from: http://www.jisppd.com/text.asp?2017/35/2/156/206041

   Introduction Top

Conscious sedation is an alternative method for the behavioral management of young, anxious, and apprehensive children in the dental clinic. This technique, regardless of the agent employed, places a patient in such a psychological state that routine dental procedures can be carried out under local anesthesia. Fear and anxiety in the dental clinic can be eliminated, thus allowing a relaxed, pain, and apprehension-free dental treatment to be administered.

Inhalation sedation with nitrous oxide-oxygen sedation has been established as a method for conscious sedation for many years. This technique uses subanesthetic concentrations of nitrous oxide delivered with oxygen in titerable dose from dedicated machinery through a nasal mask.[1] Nitrous oxide has nearly all the characteristics of an ideal analgesic agent, that is, safe, noninvasive delivery, lack of serious side effects, simplicity of use, and a rapid onset and offset of action.[2] In dentistry, general dental practitioners and specialists alike use nitrous oxide to reduce fear and discomfort associated with provision of local anesthesia and the surgical procedure itself.

Oral sedation is the oldest known route that is effective, economic, and easy to use among all routes of conscious sedation.[3] High patient acceptance is the key advantage of the oral route apart from its other advantages. Triclofos sodium is a commonly used sedative drug used for oral sedation. It is the phosphate ester of trichloroethanol, the pharmacologically active metabolite of chloral hydrate. Its comparatively less unpleasant taste makes it more acceptable than chloral hydrate for oral administration in children.[4] Triclofos sodium, although a better alternative to chloral hydrate, has comparatively scarce literature to substantiate its use and effectiveness in pediatric oral sedation.

Although there are various routes and drugs which are available to attain the state of conscious sedation, the search for a predictable, safe, and efficacious sedative protocol still continues. Hence, the aim of the present study was to evaluate the efficacy of nitrous oxide-oxygen and triclofos sodium as conscious sedative agents.

   Methodology Top

Ethical clearance to conduct the study was obtained from the Institutional Review Board. Ninety-three healthy, anxious, potentially cooperative, and apprehensive children aged 5–10 years from the monthly outpatient department were screened for the study. Among the patients screened, only those requiring extractions, restorations, and endodontic treatment were selected for the study. Children with any known allergy or hypersensitive reaction to drugs being used in the procedure and medically compromised children were excluded from the study.[5] Physical evaluation and preanesthetic evaluation were carried out by a pediatrician and an anesthesiologist, respectively. Of these, sixty children aged 5–10 years formed the study group. The parents and/or guardian were informed about the condition of the child's dental status. Verbal and written consent was obtained from each child's parents/guardians after they were informed about the dental procedures, possible discomforts or risks, as well as the possible benefits of treatment under sedation. Participation in the study was voluntary.

The demographic details including the child's age, weight, and medical status were recorded. All the parents were explained in detail about inhalation and oral route and given a choice to select the route of administration. Based on the parent preference of the route of administration, children were then randomly divided into two groups (Groups A and B) of 30 children each. Group A received 40% nitrous oxide-60% oxygen and Group B received triclofos sodium (Pedicloryl™) (70 mg/kg body weight) in the syrup form.

On the day of appointment, nil per oral status was strictly followed. The parents were instructed to keep their child's stomach empty for 4 h in case of solids and 2 h in case of liquid foods before reporting time.[6] All procedures were scheduled for early morning appointments. The sedative agents were administered by the anesthesiologist.

Procedure for Group A

Nitrous oxide-oxygen was administered using a Matrix ® MDM inhalation sedation unit. The gases were titrated at a rate of 10% nitrous oxide every minute to 40% nitrous oxide/60% oxygen. It was considered to be an ideal sedation when the patient stated that he/she began to experience feeling of warmth throughout his or her body, numbness of the hands and feet, eyes taking a distant gaze with sagging eyelids, and a feeling of euphoria and a feeling of lightness or of heaviness of the extremities.[7]

Once the patient started showing the appropriate signs of sedation, the dental treatment was commenced. The level of 40% nitrous oxide was maintained throughout the dental procedure, with reassurance and distraction being provided by the clinician to enhance the sedative effect. At the end of the treatment, 100% oxygen was administered for at least 3–5 min before removing the nasal mask.[7]

Procedure for Group B

For calculation of drug dosage, weight of the patient was recorded. The drug was administered by the anesthesiologist, in the presence of the child's parent(s) or guardians. The time of drug administration was noted. Following oral administration of the drug, the patient was shifted to a quiet room where he/she was kept under continuous observation. An adequate level of sedation was considered at a point when the patient appeared relaxed, demonstrated slurring/slowing of speech, a delayed response to verbal commands, and ultimately willingness for treatment to be carried out. The time of onset of sedation was recorded before starting the dental treatment.

For both the groups, ventilator frequency, pulse, and oxygen saturation were recorded at baseline and during the entire procedure at 5 min interval for 30–45 min.

All the children received dental treatment by the same dental operator for duration of 30–45 min. The dental treatment comprised restorations, pulp therapy, and extractions of primary teeth. The complete sedation procedure during the dental treatment was monitored by the anesthesiologist.

Throughout the dental treatment procedure, the child's behavior was recorded using the first three categories of the Houpt's behavior rating scale for sleep, body movement, and crying. The fourth category of the scale, overall behavior, was used to indicate the outcome of the treatment session.[8] All the scores were recorded by the assisting dental surgeon sitting next to the operator. All physiologic parameters were monitored throughout the treatment in the presence of an anesthesiologist. The operator was also equipped to manage any possible emergency.

At the completion of the dental treatment, the patient was transferred to the recovery room, where monitoring continued, and the patient was kept under observation. The patient remained in the recovery room for at least 20 min following the termination of nitrous oxide inhalation sedation and for at least 60–90 min following termination of treatment under oral triclofos sodium. For discharge of the patient, a discharge criterion was followed.[6] Instructions concerning food intake, medications, and observation for possible late complications were given to the parent and or guardian.

Before discharge, the patient and the parents were asked to give their level of acceptance regarding route of sedative agent administration. The patients were recalled after 24 h to seek information on any postdischarge adverse events.

The data obtained were collected and subjected to statistical analysis. The sleep, bodily movement, crying, and overall behavior based on Houpt's scale were evaluated using the Mann–Whitney U-test. The demographics and level for acceptance of route of administration of the drug were evaluated using the Chi-square test (P ≤ 0.005).

   Results Top

Comparison of sleep, body movement, crying, and overall behavior between the groups showed that, for sleep, Group A and B showed mean values of 4.00 ± 0.00 and 3.73 ± 0.52, respectively, which was significantly different (P = 0.005) [Table 1]. Parent of only one child showed poor acceptance of the route of administration in Group A, while 100% acceptance was observed among parents from Group B [Table 2]. The patient acceptance was good in 73.33% in Group A and 100% for Group B. There was a statistically significant difference between both the groups (P = 0.002) [Table 3].
Table 1: Comparison of sleep, body movement, crying, and overall behavior between the groups using Houpt's scale

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Table 2: Parental acceptance of route of administration for conscious sedation

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Table 3: Patient acceptance of route of administration for conscious sedation

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   Discussion Top

A primary objective during dental procedures is to develop a positive attitude toward dentistry. Fortunately, most children progress easily and pleasantly through their dental visits without undue pressure on themselves or the dental team. This success can be attributed to a number of factors, such as child's confident personality, parent's preparation of the child for the dental appointment, or dental team's excellent communication skills.[7] However, children who are very young, special children, and dental phobics need a pharmacological means of behavior management.

Combination of drugs has been in practice for a long time but has its own hazards. When drugs are used in combination, synergistic effects are more pronounced and thus the efficacy of a single drug cannot be determined. The administration of 30%–50% nitrous oxide to children sedated with chloral hydrate resulted in progression from moderate to deep sedation.[9] Therefore, two sedative agents, namely, triclofos sodium and nitrous oxide-oxygen, were individually evaluated and compared for their efficacy and patient acceptance.

Controversy exists regarding the preprocedural fasting for conscious sedation. The available literature does not provide conclusive evidence that preprocedural protocol for fasting decreases the incidence of adverse events during sedation.[10],[11] According to the American Academy of Pediatric Dentistry, since the absolute risk of aspiration during procedural sedation is not yet known, guidelines for fasting periods before elective sedation should generally follow those used for elective general anesthesia.[6]

Nitrous oxide-oxygen is widely used because of its provision of a significant analgesic effect with minimal respiratory depression at concentrations <50%. It achieves a rapid peak clinical effect and is rapidly eliminated from the system when administration is stopped.[12] Apprehensive children who are potentially cooperative are ideal candidates for this technique. In the present study, 83% of the children showed successful sedation outcomes with nitrous oxide-oxygen, which is concurrent with earlier reports of 77%–97%.[1],[13],[14],[15]

Success can be attributed to the amnesic and hypnosuggestive properties of nitrous oxide-oxygen. These properties are advantageous when treating children. The short attention span of a child often requires additional patient management and time when completing a procedure. Children are also much more hypnosuggestive than adults. Therefore, a calm, slow, soothing voice facilitates the action of nitrous oxide-oxygen immensely.[12]

In the present study, among the 17% of children who showed a poor sedation outcome, 10% of them did not accept the nasal mask, and in 7% of children, the necessary sedative effect was not obtained. This can be attributed to the nasal anatomy which results in unavoidable air entertainment when delivering nitrous oxide-oxygen through the nasal masks. Furthermore, in young children, there is always a possibility of movement during administration. These masks are held in position mainly by the breathing circuit attached to it and do not always produce an airtight seal.[2] These results imply that there will always be a small number of patients, for whom treatment with inhalation sedation will be unsuccessful.

Triclofos sodium is a widely available oral sedative agent. Differing results have been reported when chloral hydrate has been used alone or in combination with other sedative drugs.[16],[17],[18] The peak effect of triclofos sodium is seen in 40–60 min following administration and lasts for 40 min. In our study also, triclofos sodium when used as a sole agent showed effective sedation in 90% of the children. Wilson et al. noted that significantly higher doses of chloral hydrate may be necessary to overcome more discomforting stimuli of certain dental procedures in many young children.[19] However, such practice may lead to deep sedation, compromising patient safety. Reeves et al., who used chloral hydrate with hydroxyzine without nitrous oxide supplementation, found that 60% of sessions showed overall good results.[16]

Under nitrous oxide-oxygen inhalation sedation, all children were awake and responsive throughout the procedure. Since most of them were awake, it could have led to more crying. However, with triclofos sodium, 20% of children showed drowsy and disoriented behavior during the dental treatment. This could be due to the profound depressant effect of triclofos sodium on the central nervous system. However, it is safe for the child to be awake so as to monitor the depth of sedation from conscious to deep sedation, thus avoiding any further complications.

According to certain authors,[16],[17],[18] crying is an indication of sedation failure and could possibly cause psychological trauma. There are still others who expect crying and/or movement of children and consider it a success if they are able to complete the required treatment. Due to amnesic properties of nitrous oxide-oxygen and triclofos sodium, in spite of intermittent crying and body movement, dental treatment was completed, with a success of 90% for triclofos sodium and 83% for nitrous oxide-oxygen.

Prevailing parental attitudes toward behavior management techniques are subjective to change over time. In the current study, two different and commonly practiced routes of administration were evaluated so as to understand the most preferred method, both by parents and children. Parents accept behavior management techniques more readily if the technique's purpose is extensively explained to them.[22] It is also reported that parents show better acceptability of the technique once it is actually applied on their child. This could be the reason for higher acceptance of both the routes in our study.

In the present study, all the children accepted the oral route and 73% of children accepted the inhalation route which was in accordance with previous studies.[23],[24],[25] Individual child temperament affects the way a child reacts to the nasal mask. Various studies have shown that acceptance of inhalation route among children is better as they grow older. Children younger than 36 months of age would be expected to cry and refuse the nasal mask due to immature cognitive development, whereas children older than 36 months may be expected to display more cooperative behavior during sedation, because of more refined coping skills.[12] Fnaish demonstrated that there was a significant difference between the mean age of patients who completed treatment compared with those who did not, with older children showing better results.[15] Another possibility for children accepting the oral route of administration could be as they were more familiar with taking oral formulations for other reasons.

Adverse events with varying degree of severity have been reported during pediatric sedation including neurologic damage and death. These have been associated with drug regimens and sedatives, especially when medications are administered “outside the safety net of medical supervision.”[26] In the present study, there was an incidence of vomiting with only one child during administration of nitrous oxide-oxygen, in spite of following the preprocedural fasting guidelines. Needleman et al. reported 8.1% vomiting intraoperatively using chloral hydrate/hydroxyzine/nitrous oxide-oxygen.[27] Badalaty et al. also found an occurrence of vomiting in one patient during an administration of chloral hydrate.[28] Houck and Ripa suggest that children have a natural tendency to vomit easily that is unrelated to eating before treatment, increased concentration of nitrous oxide, or duration of the sedative procedure.[29]

   Conclusion Top

Effective sedation was obtained with nitrous oxide-oxygen (inhalation route) and triclofos sodium (oral route) for the dental treatment of 5–10-year-old children. A higher number of children preferred the oral route of sedation as compared to the inhalation route. Parental acceptance for both routes was good.

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   References Top

Holroyd I. Conscious sedation in pediatric dentistry. A short review of the current UK guidelines and the technique of inhalational sedation with nitrous oxide. Paediatr Anaesth 2008;18:13-7.  Back to cited text no. 1
Klein U, Robinson TJ, Allshouse A. End-expired nitrous oxide concentrations compared to flowmeter settings during operative dental treatment in children. Pediatr Dent 2011;33:56-62.  Back to cited text no. 2
Malamed SF. Sedation: A Guide to Patient Management. 5th ed. California: C.V. Mosbey Co., Elsevier; 2010.  Back to cited text no. 3
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American Academy of Paediatric Dentistry. Guidelines on use of nitrous oxide for paediatric dental patients. Am Acad Pediatr Dent 2009;32:10-1.  Back to cited text no. 5
American Academy of Pediatric Dentistry. Guideline for monitoring and management of paediatric patients during and after sedation for diagnostic and therapeutic procedures. Pediatr Dent 2011;35:205-21.  Back to cited text no. 6
Dean JA, Avery DR, McDonald RE. McDonald and Avery's Dentistry for the Child and Adolescent. 9th ed. Elsevier Mosby, St. Louis, Missouri: Mosby Inc.; 2011.  Back to cited text no. 7
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Treston G. Prolonged pre-procedure fasting time is unnecessary when using titrated intravenous ketamine for paediatric procedural sedation. Emerg Med Australas 2004;16:145-50.  Back to cited text no. 10
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Wilson KE, Girdler NM, Welbury RR. Randomized, controlled, cross-over clinical trial comparing intravenous midazolam sedation with nitrous oxide sedation in children undergoing dental extractions. Br J Anaesth 2003;91:850-6.  Back to cited text no. 13
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[PUBMED]  [Full text]  
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  [Table 1], [Table 2], [Table 3]

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