Carolin Von Mullai, A (2010) Comparison of Intranasal Midazolam with Oral Midazolam for Premedication in Children. Masters thesis, Stanley Medical College, Chennai.
|
Text
201000210carolin_von_mullai.pdf Download (1MB) | Preview |
Abstract
INTRODUCTION: Surgery and anaesthesia induce considerable emotional stress and psychological consequences in children. This stress may remain in the child’s psyche long after the hospital experience has passed, and it was first described by Duputyren in 1834. Age, parental anxiety level, previous hospital experiences and type of surgery are factors that can influence a child’s anxiety level and psychological well being. Preoperative anxiety stimulates sympathetic, parasympathetic and endocrine system leading to an increase in heart rate, blood pressure and cardiac excitability. These reactions reflect the child’s; • fear of separation from parents and home environment. • fear of physical harm. • fear of unfamiliar routines. • fear of surgical instruments and procedures. The preoperative interventions directed towards reduction of anxiety can be grouped into psychological and pharmacological methods. The introduction of new drugs and alternative routes of administration like transmucosal route in last decade by avoiding painful intramuscular injections, the most horrifying experience for a child, has facilitated a more rational approach to premedication for paediatric patients. In paediatric anaesthesia, premedication needs to be in an acceptable form, to have a rapid onset with minimal hangover effect and without side effects. Midazolam, a sedative with all the desirable properties of a benzodiazepine was introduced into clinical practice in 1980s. Midazolam, a water soluble benzodiazepine, may be administered by various routes. Oral and rectal routes are used widely and provide effective sedation. However, there are concerns about the wide bioavailability when given by these routes , ranging from 18% to 44% with an appreciable first pass effect. Intramuscular administration is painful and the sublingual route has poor compliance. The intranasal route for midazolam has been used since 1988 and has the advantage of rapid absorption directly into the systemic circulation with no first pass effect and a bio- availability of 55-83% Intranasal midazolam is absorbed from an area rich in blood supply and avoids the disadvantage of passing through the portal circulation, thus increasing the bio-availability of the drug. Tolerance to midazolam is good, and the duration of action is shorter and more predictable than other benzodiazepines. Intranasal midazolam has all the advantages of intravenous administration without the disadvantages of pain and fear associated with intramuscular and intravenous injections. AIM OF THE STUDY: The aim of the study is to compare the effectiveness of Intranasal and oral midazolam used as a premedication in paediatric patients undergoing minor elective surgical procedures. MATERIALS AND METHODS: Seventy paediatric patients belonging to ASA physical status I and II scheduled for elective minor surgical procedures were included in the study. Children belonged to age group of 2 to 8 years of both sexes. The children were randomly allocated into 2 groups with 35 patients in each group. (Group N and Group O). It was a comparative study. The study was approved by the Institutional Ethical Committee and parents provided written informed consent before premedication of their children. Inclusion Criteria: 1. ASA I and II physical status, 2. Age group 2-8 yrs, 3. weight < 20 kgs. Exclusion Criteria: 1. ASA III and IV, 2. Nasal Infection, 3. Nasal Pathology, 4. Nasal Allergy and URI, 5. Children with Seizure disorder, 6. History of adverse reactions to benzodiazepines, 7. patient taking other sedative drugs. MATERIALS 1. Nasal midazolam spray (Insed atomiser), 2. Oral midazolam. Preparation of the Patient: Written informed consent from the parent obtained. All patients fasted as per NPO guidelines. Demographic data including age, weight and sex of the children were recorded. The children were given premedication 30 minutes before surgery orally or nasally. The reaction of the children to the premedication was noted. SUMMARY: We compared the efficacy of midazolam as a paediatric premedication when used in two different routes. Midazolam was used as premedication in intranasal and oral routes in children undergoing minor surgical procedures and the efficacy of the drug in producing preoperative sedation, anxiolysis and cooperation during separation from the parents, venepuncture and face mask application was compared using separate scoring systems. The following observations were made during the study. There are no significant differences between the two groups in demographic data. The time of onset of sedation is 8.42 minutes with intranasal midazolam and 15.82 minutes with oral midazolam. We observed that intranasal midazolam has more rapid onset of action compared to oral midazolam, which is statistically significant. The sedation scores are better with intranasal midazolam than oral midazolam at 10 minutes, 20 minutes and30 minutes which are statistically significant. The anxiolysis is better with nasal midazolam group with statistical significance. There is no significant difference in the co-operation score for venepuncture, separation from the parents and mask application between the two groups. No patient was oversedated or drowsy postoperatively. No complications were observed in both the groups. CONCLUSION: In conclusion, Intranasal midazolam when used as a premedication in children, in a dose of 0.2 mg/kg has more rapid onset of action with satisfactory sedation and anxiolysis than oral midazolam. The rapid onset of action of nasal midazolam makes it an ideal route for premedication in children.
| Item Type: | Thesis (Masters) |
|---|---|
| Uncontrolled Keywords: | Intranasal Midazolam ; Oral Midazolam ; Premedication ; Children ; Comparison study. |
| Subjects: | MEDICAL > Anaesthesiology |
| Depositing User: | Subramani R |
| Date Deposited: | 22 Apr 2018 16:05 |
| Last Modified: | 28 Apr 2018 13:32 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/7246 |
Actions (login required)
 |
View Item |
