Evaluation of the sedative effect of rectally administered diazepam for the young dental patient.

Rectal diazepam was evaluated for its sedative effect on the difficult-to-manage child in the dental setting. A placebo was used as a control. In a double-blind study, 12 uncooperative patients with a mean age of 3.75 years were selected using the Frankl scale, Ratings I and 2. Each child was seen fbr an initial examination and 2 standardized restoratfve treatment visits. Randomly, a dosage of 0.6 mg/kg of either diazepam or sodium chloride was dispensed through a soft, rubber catheter. Videotapes were recorded for bot}i treatment visits on all children during a specific 6-min segment. These were reviewed later by 3 judges using a kinesics/vocalization instrument. The results of this study indicated that rectal diazepam (0.6 mg/kg) is an effective, predictable, and safe sedative which adapts: well to the routine dental appointment for the young pediatric dental patient. Patient management provides the pediatric dentist with unique responsibilities to help the child make appropriate emotional and behavioral responses. Although most young children are able to control their behavior adequately in the dental setting, 1 there are certain apprehensive patients who are management problems for the most experienced clinician. For some of these anxious children, pharmacological adjuncts are a temporary method for safely and efficiently rendering quality oral health care. A wide variety of medications have been recommended for managing the anxious child, but there are few controlled investigations evaluating behaviormodifying drugs for use in the dental setting. Diazepam is one agent that has been used with some frequency by pediatric dentists. 2 Although the antianxiety property of diazepam has been described in many clinical studies, evidence supporting its benefits in pediatric dentistry has been equivocal and varies with the route of administration. B-6 The most common routes for administering diazepam during dental treatment are intravenous (W) and oral. The rectal approach, using diazepam in solution, has some advantages. Since diazepam is highly lipophilic, it is absorbed rapidly through the mucosal membranes of the colon. For this reason, the rectal route is the second most rapidly absorbed method in children. 7-9 When this method is compared to oral administration, a faster and more reliable peak plasma concentration is obtained per rectum. Peak serum levels, when administering diazepam rectally, are obtained within 5-10 min in children, with small individual differences. 7,1° The same medication given orally reaches a peak plasma level within 30-90 rain on the average, ~ exhibiting up to a 30-fold individual variability. ~2 In addition, the clinical duration of action, when given rectally, compares more favorably with a pediatric dental appointment. Sedative effects have been observed up to 120 min for oral administration, ~3 whereas this effect is decreased to 60 rain using the rectal approach. 6 Although IV diazepam has proven to be a satisfactory sedative in dentistry, it has its limitations in pediatric dentistry. Despite its more rapid attainment of peak plasma levels in 1-5 min~ and shorter acting sedative effect of 45 rain, ~5 it requires patient cooperation for administration. For the difficult-to-manage child unable to cope with anxiety-provoking stimuli, this route may be traumatic. Furthermore, overt body movement by the patient could displace the IV needle. Rectal diazepam has been shown to be an effective and practical alternative with blood levels as high as 80% of that attained intravenously. 7 The purpose of this study was to evaluate the sed292 RECTAL DIAZEPAM: Flaitz and Nowak ative effect of rectal diazepam on the behavior of uncooperative pediatric dental patients when compared to a placebo. A kinesics/vocalization instrument was used to measure the behavioral responses of the child and operator in the dental setting. Methods and Materials The patients in this study included 12 children between 2and 6-years-old (mean age, 3.75). Selection of these difficult-to-manage pediatric patients was made at an initial examination visit by pediatric dental faculty. All children were identified as being negative or definitely negative toward dental treatment as defined by the Frankl scale, Ratings 1 and 2.16 Minimum treatment requirements for the children were 2 Class I alloy restorations on primary molars. The investigation was conducted using a doubleblind design in which neither the dental operator nor child were aware of the agent dispensed. Each patient was required to return to the dental clinic for 3 separate appointments, including the initial examination visit and 2 treatment visits. The children were divided randomly into 2 groups. Group A received the placebo at the first appointment and diazepam at the second, while group B received diazepam at the first appointment and the placebo at the second. The children were instructed to ingest nothing 4 hr prior to the treatment visits as a precautionary measure against vomiting and aspiration. A sedative dose of 0.6 mg/kg of diazepama in solution was administered because of the satisfactory sedative effects, reported by Lundgren et al. in the young pediatric dental pafient. 6 This predetermined dosage of diazepam was drawn up into a 3 cc plastic syringe. After the needle was removed from the syringe, a soft rubber catheter was attached to the hub, and the tip of the catheter was coated with a lubricating jelly for easy insertion. The child lay over the knees of the parent to aid in administration. After dispensing the medication per rectum, a bolus of air was used to clear the remaining contents of the syringe. In a similar manner, bacteriostatic sodium chloride was drawn up for the placebo. The agents were administered by a pediatric dentist in a standardized operatory, equipped with an overhead camera. The same dentist and dental assistant were responsible for patient treatment and Valium ® (diazepam) package insert, 1979 -Roche Laboratories, Division of Hoffman-LaRoche, Inc: Nutley, NJ. The diazepam solution administered to the children was Valium® Injectable. As described by the package insert: Each ml contains 5 mg diazepam compounded with 40% propylene glycol, 10% ethyl alcohol, 5% sodium benzoate and benzoic acid as buffers, and 1.5% benzyl alcohol as preservative. management. The dentist was unaware of the agent administered to the child prior to treatment. The restorative procedure was initiated 10-15 min after administering the medication. Every appointment was videotaped and later divided into six 1-min segments for future evaluation. The first 3 min of the film included the local anesthetic injection and the period immediately following. The fourth minute coincided with rubber dam application, the fifth started with cavity preparation, and the final minute included the condensation and carving of the amalgam restoration. Blood pressure and pulse were recorded 4 times during the appointment by the dentist. The videotapes were reviewed by 2 pediatric dentists and a dental assistant utilizing the kinesics/vocalization instrument. 17,1s The 6 behavioral categories evaluating the child’s responses included: 1. Head and oral movements 2. Upper extremity movements 3. Torso movements 4. Lower extremity movements 5. Vocalizations by the patients 6. Requests and commands by the dentist. The patient’s movements were subdivided into interfering and noninterfering behavior. Interfering behavior was defined as those actions which produced a disruption in the clinical procedure, while noninterfering behavior was judged to be inconsequential to treatment progress. Each evaluator reviewed the filmed treatment appointment and independently recorded the child’s behavioral responses and dentist’s voice commands during the specified 6-min periods. An audible tone was incorporated into the soundtrack of the film which divided each minute into 10-sec intervals to quantify the duration of the behavioral responses. The minimum number of responses for each behavioral category during the 6-min filmed segments was 0 and the maximum was 36. Videotapes of these treatment appointments were reviewed up to 6 times in order to record all the behavioral responses correctly. After final viewing of the filmed treatment appointment, evaluators assigned a Frankl scale rating to the entire procedure. Analysis of variance (ANOVA) was used to examine the sedative effect of diazepam and placebo on the children’s behavior during the treatment visits. A significance level of p -< 0.05 was considered acceptable. Tables illustrating the means of these treatment groups were constructed for the 6 behavioral responses defined by the kinesics/vocalization instrument. The Pearson’s Product-Moment Correlation Test was utilized to compare the Frankl scale ratings with the kinesics/vocalization instrument. The significance PEDIATRIC DENTISTRY: December 1985/Vol. 7 No. 4 293 level for this test was p -< 0.05. The reliability of the kinesics/vocalization instrument and the Frankl scale rating was analyzed using the interrater reliability coefficient.