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Table of Contents
ORIGINAL ARTICLE
Year : 2015  |  Volume : 2  |  Issue : 1  |  Page : 92-95

Oral clonidine and midazolam as premedication in pediatric anesthesia- Efficacy and outcome in comparison with oral promethagine


1 Department of Anesthesiology and Intensive Care, Combined Military Hospital, Dhaka, Bangladesh
2 Department of Anesthesiology, United Hospital, Gulshan, Dhaka, Bangladesh

Date of Web Publication4-Jul-2017

Correspondence Address:
Abul Kalam Azad
Classified Anesthesiologist, Dept of Anesthesiology and Intensive Care, Combined Military Hospital, Dhaka-1206
Bangladesh
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Source of Support: None, Conflict of Interest: None


DOI: 10.5530/ami.2015.1.15

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  Abstract 


Background: In most of the centers of developing country no premedication is used in cases of anesthesia in paediatric population. Many centers use oral promethagine on the night before to ensure good sleep. There is dilemma of using premedication with a fear of losing control over baby. There are controversial results regarding the effectiveness of clonidine compared with midazolam as premedication in children. Aim: The aim of this study is to evaluate the efficacy of oral clonidine and midazolam as a premedication and compare to with that of conventional promethagine in pediatric patients. Methods: This prospective randomized controlled study was carried out in Combined Military Hospital, Dhaka, among 90 children aged 2 to 7 years of ASA grade I & II scheduled for elective surgery under general anaesthesia during the period of Jan 2012 to Dec 2013. All the children were randomly divided in three groups, 30 children received only syrup promethagine as per body weight (Group-P, n=30) at night. In the study groups, after the syp promethagine at night in addition they were also given oral clonidine 4 μg/kg mixed with honey (Group-C, n=30) and midazolam 0.5 mg/kg mixed with honey (Group-M, n=30) at 60 and 20 min before separation of baby from parents lap respectively. The protocol of general anesthesia like induction, intubation, maintenance, reversal and postoperative analgesia was the same for all three groups. Patient's sedation status, separation anxiety, venipuncture, mask acceptance, anesthetics requirement, salivation, analgesia, post operative nausea vomiting (PONV) and emergence agitation were recorded by an observer blind of the patient's group. Results: Children characteristics were similar in all three groups. Children who had received clonidine as well as midazolam had more satisfactory sedation upon parent separation and less separation anxiety than promethazine; compared with midazolam & promethazine, clonidine premedication was associated with better mask acceptance; children who had received clonidine had significantly less incidence of salivation and less rescue antisialagogue; children received clonidine were better managed both intra & post operatively and needed less rescue analgesics; children who had received clonidine had significantly less episodes of PONV and also required less rescue antiemetic; incidence of emergence agitation was less in clonidine group in comparison with other two groups. Conclusion: The findings of the study suggest that both midazolam and clonidine are safe and effective as anaesthetic premedication in paediatric population. It can be concluded that oral midazolam premedication is effective as far as sedation is concern but considering multifarious anesthetic function oral clonidine is much superior premedicant. However, the risks of heart rate and blood pressure decreases, and the prolonged onset of sedation associated with clonidine should be considered. We recommend further multi-centre studies with larger samples to validate findings of our study.

Keywords: Clonidine, Midazolam, Premedication, Antisialagogue, PONV


How to cite this article:
Azad AK, Ahsan MN, Islam MS. Oral clonidine and midazolam as premedication in pediatric anesthesia- Efficacy and outcome in comparison with oral promethagine. Acta Med Int 2015;2:92-5

How to cite this URL:
Azad AK, Ahsan MN, Islam MS. Oral clonidine and midazolam as premedication in pediatric anesthesia- Efficacy and outcome in comparison with oral promethagine. Acta Med Int [serial online] 2015 [cited 2020 Nov 25];2:92-5. Available from: https://www.actamedicainternational.com/text.asp?2015/2/1/92/209458




  Introduction Top


One of the challenge for pediatric anesthesiologists is to minimize psychological upset and scaring for children in the operating room environment and to facilitate a smooth induction of anesthesia.[1] Children are occasionally frightened and become uncooperative during the induction of anesthesia.[2],[3] It has been reported that more than 40% of children aged 2–10 years display some distress behavior during the induction of anesthesia and more than 30% of children resist anesthesiologists during induction.[4] The use of positive reinforcement to handle severely anxious and scared children may lead to postoperative behavioral problems.[5],[6] Thus, the use adequate premedication to provide anxiolysis may be beneficial for the facilitation of peaceful separation and the induction of anesthesia in these children.

Pre-operative anxiety is known to prolong the induction of anesthesia and lead to new-onset of maladaptive behavior in the post-operative period.[7],[8] Premedication in children prior to anesthesia induction provides anxiolysis, facilitate the separation from parents, and lessens the adverse psychological effects of hospital stays.[9],[10] Non-parenteral routes of administration for premedication is preferred in children because they perceive intravenous (IV) or intramuscular (IM) medication as more invasive than the procedure itself.[11],[12]

In most of the centers of developing country no premedication is used in cases of anesthesia in paediatric population. Many centers use oral promethagine on the night before to ensure good sleep. There is dilemma of using premedication with a fear of losing control over baby. There are controversial results regarding the effectiveness of clonidine compared with midazolam as premedication in children.


  Methods Top


This prospective randomized controlled study was carried out in Combined Military Hospital, Dhaka, among 90 children between 2 to 7 years of age. Study was conducted among children scheduled for elective surgery under general anaesthesia having American Society of Anesthesiologists (ASA) grade I & II during the period of Jan 2012 to Dec 2013. Exclusion criteria included known allergy or hypersensitive reaction to promethagine, clonidine or midazolam. We also excluded children having organ dysfunction, cardiac arrhythmia, congenital heart disease, mental retardation, airway abnormalities and severe obesity. Pre-anaesthetic checkup was done 24 hrs prior to surgery and the procedure was explained to the parents and written consent was obtained. They were randomly allocated to one of three groups by blind envelope technique.

Group-P

In promethagine group, patient received only syrup promethagine as per body weight (Group-P, n=30) at night.

Group-C

In clonidine group, after syp promethagine at night in addition patients were also given oral clonidine 4 μg/kg mixed with honey (Group-C, n=30) at 60 min before separation of baby from parents lap.

Group-M

In midazolam group, after syp promethagine at night in addition patients were also given oral midazolam 0.5 mg/kg mixed with honey (Group-M, n=30) at 20 min before separation of baby from parents lap.

Children had premedication in preoperative holding area in the presence of one parent. Baseline HR, oxygen saturation (Spo2), and BP were measured before any drug administration. In pre-op hold area, children belong to group-P received only syrup promethagine at night was quiet and awake at parents lap. Children belong to group-C received oral clonidine 4 μg/kg mixed with honey 60 min before separation of baby from parents lap. On the other hand, children belong to group-M received oral midazolam 0.5 mg/kg mixed with honey 20 min before separation of baby from parents lap. HR, Spo2, and BP were measured before and every 15 min after drug administration until transfer to the theater. The level of sedation was assessed by using a 3-point scale: 1 = awake, 2 = drowsy and 3 = asleep. A sedation score of ≤2 was considered as satisfactory [Table 1].
Table 1: Sedation scale

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When a sedation score of 2 or 3 was reached, the children were transferred to the operating room. Nurses used to accompany the child inside theater if no satisfactory sedation level was achieved these children were excluded from the study. The duration of premedication was approximately 60 min; however, it could be longer or shorter depending on the schedule of the OT list. On arrival at operation theatre again baseline preinduction parameters like heart rate, NIBP, SpO2 were recorded. The protocol/ technique of general anesthesia like induction, intubation, maintenance, reversal and postoperative analgesia was same for all three groups. Patient's venipuncture, mask acceptance, anesthetics requirement, salivation, analgesia, post operative nausea vomiting (PONV) and emergence agitation were recorded by an observer blind of the patient's group. At the end of surgery children were placed in recovery position and allowed to wake up naturally in the postanesthesia care unit (PACU).


  Results Top


A total 90 patients were included in this study. Demographic characteristics for all three groups are summarized in [Table 2]. Patients' characteristics were similar in the three groups. There was no statistically significant difference between the groups with respect to sex, age and weight. But in clonidine group, there are significant differences in the mean values of heart rate, systolic and diastolic blood pressures in comparison with other groups [Table 2].
Table 2: Patients' demographic data

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Children of clonidine and midazolam groups had more satisfactory sedation upon parent separation and less separation anxiety than promethazine group [Table 3].
Table 3: State of sedation and separation anxiety

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Compared with midazolam & promethazine, clonidine premedication was associated with better mask acceptance [Table 4].
Table 4: Better mask acceptance

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Children who had received clonidine had significantly less incidence of salivation and less rescue antisialagogue [Table 5].
Table 5: Incidence of salivation

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Children received clonidine were better managed both intra & post operatively and needed less rescue analgesics [Table 6].
Table 6: Rescue analgesics

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Children who had received clonidine had significantly less episodes of PONV and also required less rescue antiemetics [Table 7].
Table 7: No post operative nausea vomiting (PONV)

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Finally, the incidence of emergence agitations was less in clonidine group in comparison with other two groups [Table 8].
Table 8: Incidence of emergence agitation

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  Discussion Top


To evaluate the efficacy of oral clonidine and midazolam as premedication and to compare with that of conventional promethagine in pediatric patients this study was conducted in Combined Military Hospital, Dhaka.

Reduction of anxiety experienced by children is important for humanitarian reasons and to improve cooperation with medical staffs. Anxiety at induction of anesthesia is associated with distress on awakening in the recovery area and with later postoperative behavior problems.[13]

Perioperative anxiety has been associated with much negative behaviour during and after the surgical experience, like post-operative pain, sleeping disturbances, parent child conflict and separation anxiety.[14],[15]

It also activates the human stress response, leading to increased levels of serum cortisol and epinephrine and natural killer cell activity.[16] Children are particularly vulnerable to the global surgical stress response because of the limited energy of the reserves, large brain masses and the obligatory glucose requirements.[17]

Limitation of the study was that potential alteration in the absorption of drugs based on pH changes induced by the diluents - honey in this case was not addressed in the study.[18]

This study demonstrated that age old practice of providing promethazine at night neither reduces perioperative anxiety nor humanitarian. In contrast, clonidine and midazolam effectively reduced separation anxiety which is consistent with Rubina et al, R2 Rony et al and Halldin- Lindahl et al study.[14],[19],[20] Besides, clonidine was a suitable alternative to midazolam as a premedication in children which is consistent with Rubina et al, R2 Rony et al study. Furthermore, clonidine acts as a sedative and analgesic because of its central alpha-2 adrenergic agonism as well as provides better hemodynamic stability, mask acceptance and reduces salivation, PONV, emergence agitation which corresponds with Rubina et al, R2 Rony et al & Halldin- Lindahl et al study.[14],[18],[20]


  Conclusion Top


The findings of the study suggest that both midazolam and clonidine are safe and effective as anesthetic premedication in pediatric population. It can be concluded that oral midazolam premedication is effective as far as sedation is concern but considering multifarious anesthetic function and demands of providing anesthesia oral clonidine is much superior premedicant. However, the risks of heart rate and blood pressure decreases, and the prolonged onset of sedation associated with clonidine should be considered. We recommend further multi-centre studies with larger samples to validate findings of our study.



 
  References Top

1.
Vivian M, Yuen. A comparison of intranasal dexmedetomidine and oral midazolam for premedication in pediatric anesthesia: a double-blinded randomized controlled trial. Canadian journal of Anaesthesia. 2003; 60(311): 24–31.  Back to cited text no. 1
    
2.
Yu Sun. Is dexmedetomidine superior to midazolam as a premedication in children? A meta-analysis of randomized controlled trials. Pediatric Anesthesia 24 (2014): 863–874.  Back to cited text no. 2
    
3.
Bozkurt P. Premedication of the pediatric patient – anesthesia for the uncooperative child. Curr Opin Anaesthesiol 2007; 20: 211–215.  Back to cited text no. 3
    
4.
Strom S. Preoperative evaluation, premedication, and induction of anesthesia in infants and children. Curr Opin Anesthesiol. 2012; 25: 321–325.  Back to cited text no. 4
    
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Chorney JM, Kain ZN. Behavioral analysis of children's response to induction of anesthesia. Anesth Analg. 2009; 109: 1434–1440.  Back to cited text no. 5
    
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Watson AT, Visram A. Children's preoperative anxiety and postoperative behaviour. Pediatr Anaesth 2003; 13: 188–204.  Back to cited text no. 6
    
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Vishnu V. A comparative study to evaluate the efficacy of oral dexmedetomidine versus oral midazolam as premedicants in children: a prospective, randomized, controlled and double blind study. International Journal of Scientific Study. 2014; 2 (5): 67–75.  Back to cited text no. 7
    
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Kain ZN. Distress during the induction of anesthesia and postoperative behavioral outcomes. Anesth Analg. 1999; 88:1042–7.  Back to cited text no. 8
    
9.
Caldwell-Andrews AA. Trends in the practice of parental presence during induction of anesthesia and the use of preoperative sedative premedication in the United States, 1995-2002. Results of a follow- up national survey. Anesth Analg. 2004; 98: 1252–9.  Back to cited text no. 9
    
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Hofstadter MB. Midazolam: Effects on amnesia and anxiety in children. Anesthesiology. 2000; 93: 676–84.  Back to cited text no. 10
    
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Alderson PJ, Lerman J. Oral premedication for paediatric ambulatory anaesthesia: A comparison of midazolam and ketamine. Can J Anaesth 1994; 41:221–6.  Back to cited text no. 11
    
12.
Bergendahl HT. Clonidine vs. midazolam as premedication in children undergoing adeno-tonsillectomy: A prospective, randomized, controlled clinical trial. Acta Anaesthesiol Scand. 2004; 48: 1292–300.  Back to cited text no. 12
    
13.
Agnes T. Watson, Visram A. Children's preoperative anxiety and postoperative behavior. Paediatric Anaesthesia. 2003; 13: 188–204.  Back to cited text no. 13
    
14.
Rubina K M. Comparison of Oral Clonidine and Midazolam as Premedications in Children. Journal of Clinical and Diagnostic Research. 2012 June; Vol-6(5): 870–873.  Back to cited text no. 14
    
15.
Wright KD, Stewart SH, Finley GA, Susan E, Buffett-Jerrott. Prevention and intervention strategies to alleviate pre-operative anxiety in children. A critical review. Behaviour Modification. 2007; 31 (1):32–79.  Back to cited text no. 15
    
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McCann ME, Kain ZN. The management of pre-operative anxiety in children: An update. Anesth Analg 2001;93(1):98–105.  Back to cited text no. 16
    
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Deshpande S, Platt MP, Aynsley-G A. Patterns of the metabolic and endocrine stress response to surgery and medical illness in infancy and childhood. Crit Care Med 1993; 21 (9 Suppl): S359–61.  Back to cited text no. 17
    
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Sequeira T. A comparison of midazolam and clonidine as an oral premedication in pediatric patients. Saudi J Anaesth. 2012;6: 8–11.  Back to cited text no. 18
    
19.
Web: www.anesthesiology.aub.edu.lb/./Pediatric%20 Premedication.pdf Halldin-Lindahl et al. A comparison of commonly used preanaesthetics and clonidine. Web: www. medicinedocshare.com/./6B5CE2DAF1453151B850DC862C42961.  Back to cited text no. 19
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8]


This article has been cited by
1 Postoperative Nausea and Vomiting in Pediatric Patients
Anthony L. Kovac
Pediatric Drugs. 2020;
[Pubmed] | [DOI]



 

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