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[Rectal premedication with midazolam in children. A comparative clinical study]
1Institut für Anaesthesiologie und Reanimation, Kantonales Spital Uznach.
Insights
Rectal midazolam is an effective and well-accepted anesthetic premedication for children, with higher doses showing greater sedative effects and good mask acceptance. This method offers a safe alternative to injections and oral routes.
Area of Science:
- Pediatric Anesthesiology
- Pharmacology
- Clinical Medicine
Background:
- Pediatric anesthetic premedication via injection is often poorly tolerated by children.
- Oral premedication poses aspiration risks and requires precise timing before anesthesia.
- Rectal administration offers a less disturbing alternative for children needing sedation.
Purpose of the Study:
- To evaluate the efficacy, acceptance, and safety of rectal midazolam as premedication in children.
- To compare two different doses of rectal midazolam (0.4 mg/kg vs. 0.5 mg/kg) with atropine.
- To assess the sedative-hypnotic effects and acceptance of anesthetic mask induction.
Main Methods:
- A double-blind study involving 80 healthy children aged 2-10 years undergoing elective surgery.
- Children were randomly assigned to receive either 0.4 mg/kg or 0.5 mg/kg midazolam rectally, with atropine.
- Parameters included acceptance of rectal instillation, sedative effects, vital signs, and mask acceptance.
Main Results:
- Rectal midazolam was well-accepted by 82.5% of children; no respiratory depression or allergic reactions were observed.
- The higher dose (0.5 mg/kg) resulted in significantly greater sedative effects (tired/drowsy or asleep) compared to the lower dose.
- Anesthetic mask acceptance was high (92-97%) and comparable between groups.
Conclusions:
- Rectal midazolam is a safe and effective premedication for pediatric anesthesia, with good patient acceptance.
- A higher dose of 0.5 mg/kg midazolam provides superior sedative-hypnotic effects compared to 0.4 mg/kg.
- This route offers a viable alternative to traditional premedication methods, enhancing patient comfort and cooperation.
Abstract:
Anesthetic premedication by injection is usually poorly accepted by children, especially those under 10 years of age. Less disturbing for the child is oral premedication, but this increases the risk of aspiration and must be administered 1.5-2 h before anesthetic induction. This double-blind study was performed in children to investigate the efficacy, acceptance, and general safety of midazolam given rectally. METHOD. Rectal premedication was administered to a total of 80 healthy children between 2 and 10 years of age undergoing elective operations. The children were divided randomly into two groups: group I received 0.4 mg/kg and group II 0.5 mg/kg midazolam with the addition of 0.015-0.02 mg/kg atropine. Premedication was carried out on the pediatric ward. The calculated dose was drawn from the ampule and diluted to 8-10 ml with distilled water. This dose was instilled immediately behind the anal sphincter using a suitable plastic applicator (Stanylan). The following parameters were recorded: immediate reaction to the rectal medication, sedative-hypnotic signs, and acceptance of the anesthetic mask. Heart rate and blood pressure were measured before premedication and before the induction of anesthesia. Observations were made for 5 h post-operatively. Any unusual side effects of the treatment were also noted. The existence of any anterograde amnesia was investigated in 20 children (10 in each group) between 6 and 10 years of age. RESULTS. There was no significant difference between the children allocated to the two groups with regard to age, body weight, sex, type of operation, and duration of anesthesia (Table 2). Of the total of 80 children, 66 (82.5%) accepted the rectal instillation well, 12 (15%) moderately well, and 2 (2.5%) poorly. Signs of respiratory depression or allergic reaction to midazolam were not observed in any case. The observations made before induction of anesthesia are presented in Table 3. The children in group II exhibited significantly greater (P less than 0.05) slurred speech than those in group I. A low incidence of hiccup was seen in both groups. Most of the children (27 in group I, 67.5%; 37 in group II, 92.5%: P less than 0.05) were delivered to the operating room lying down, whereas the others were sitting up in bed but showed no desire to get up. Between 10 and 55 min after the premedication, a total of 5 children (12.5%) in group I and 2 (5%) in group II were restless or crying on arrival in the induction room. Most, however, were quiet to tired/drowsy. The optimal sedative-hypnotic action was observed after 20-30 min (Fig. 1). At this time 21.7% of the children in group I were tired/drowsy, whereas 50% in group II were tired/drowsy and 9.1% were asleep but easy to arouse. This effect was significantly greater in group II (P less than 0.01). Acceptance of the mask was comparable in both groups (Table 4) and was tolerated well to very well by 92-97% of the children. (ABSTRACT TRUNCATED AT 400 WORDS)