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Comparison between Midazolam and Hydroxyzine Premedication in Pediatric Day Care Surgery

Awadh Almugadam, Aaref Al Kaabi, Kamran Malik

Department of Anesthesiology, Zayed Military Hospital, Abu Dhabi, UAE

 

Correspondence

Awadh Almugadam

Department of Anesthesiology

Zayed Military Hospital

Zayed Street, Abu Dhabi

Zip code 3740, UAE

Phone: 050 454 5301

E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.



Abstract

Background

Midazolam is a commonly used premedication in children. It was shown to be more accepted and effective than the hydroxyzine syrup in reducing anxiety and improving compliance at induction of anesthesia. The aim of this study was to compare the effectiveness of midazolam and hydroxyzine as premedication in children scheduled for day care surgery.

Material and methods

Fifty children, ages 2-8 years participated in the study. Twenty five children randomly received 0.4 mg/kg of oral midazolam (group M) and other 25 received hydroxyzine syrup 1 mg/kg (group H) 30-40 minutes before being taken into preoperative area in the operating theater. Level of sedation, separation from family, response to mask induction, pulse, oxygen saturation, pre and post-operative behavior and sleep patterns were noted every 5 minutes by an experienced recovery nurse.

Results

There were significant differences in Ramsay Sedation Score (RSS), response to parental separation and mask induction, or wake-up behavior score. When compared with group H, patients in group M were significantly more cooperative, easy to separate from parents, with less anxiety and they accepted the mask in the operation room within 30 minutes after premedication (P value < 0.05 ). Postoperative agitation was considered significantly lower in group M due to anterograde amnesia in comparison with group H. Though blood pressure and pulse were on lower side in group M than in group H, due to the effect of midazolam which could reduce pain perception by producing sedation and amnesia, oxygen saturation remained the same in both groups with no statistical significance.

Conclusion

Midazolam is more effective compared to hydroxyzine as premedication in pediatric patients having more intense sedation, excellent parent separation response and lower incidence of postoperative agitation. Vital signs were acceptable and remained the same in both groups. Mean satisfaction of patients and surgeons were significantly better in the midazolam group. 

Key words: midazolam, hydroxyzine, premedication, anesthesia


Introduction

Medical procedures can cause serious emotional and psychological trauma to children due to separation from the family, fear of the pricks, anesthesia, surgery, etc. Premedication can play an important role to avoid short term anxiety and the persistent fear in children after surgery. There is no magic drug for premedication but midazolam is routinely used as premedication due to its anxiolytic and hypnotic effects, has the great advantage of rapid onset and short duration. Midazolam, a short-acting benzodiazepine can provide safe and effective sedation before surgical procedures, with anterograde amnesia promotion [1-4].

It’s commonly reported effective oral dosage ranges from 0.3-0.5 mg/kg in children. It is quickly absorbed after administration via the oral route, can take effect within 15 minutes, reaching a peak in 30 minutes, and lasts from 20 to 90 minutes [5]. Preoperative oral midazolam has proven effective in treating preoperative anxiety [6]. Study of literature suggests various sedation protocols for monitoring patient’s behavior, sedation, reaction to separation from parents and vital signs. Hydroxyzine is a long-acting (6 to 24 hours) anti-histaminic, H1 antagonist, which acts as a central nervous system depressant, showing to be a weak anxiolytic drug.

The objective of this paper is to compare the efficacy and safety of midazolam versus hydroxyzine. The midazolam dose of 0.3-0.4 mg/kg was found very suitable, effective and save with minimal side effects on respiratory tract system.

Materials and methods

A placebo controlled randomized double blind study was designed to assess the suitability of oral Midazolam as a premedication in day care surgery in children at the Zayed Military Hospital. The protocol was approved by Hospital Ethical Committee; written informed consent was obtained from the parents of each child.

The child and his/her parents rested in the pediatric ward than were shifted to the waiting area in the operation theatre for 30 minutes before beginning the surgical procedure. The parents and the child were discharged when the appropriate discharging criteria were met. The course of sedation was observed and noted every 5 minutes by an experienced nurse. The vital signs we evaluated were: the respiratory rate, heart rate, oxygen saturation, and blood pressure.

Sedation score (Table 1), response to parental separation (Table 2), mask acceptance score (Table 3) were applied to assess the quality of premedication.

Table 1Ramsay sedation scores

 

Sedationscore

 

Levelof sedation

 

Criteria

 

Score

 

Agitated

 

Patientclingingtofamily&crying

 

1

 

Alert

 

Patientisaware,notclinging&notcrying

 

2

 

Calm

 

Quiet&comfortable  witheyesopening

 

3

 

Drowsy

 

Quiet&comfortable  withclosedeyesbutrespond  tominorstimula- tion

 

4

 

Asleep

 

Quiet& comfortable  withclosedeyesbutnotrespondtominorstimu- lation

 

5

 

Table 2: Response to parental separation 

 

Responsetofamilyseparation

 

Childbehaviorduringseparation

 

Criteria

 

score

 

Excellent

 

Childunafraid&cooperative

 

1

 

Good

 

Quietorslightcrying

 

2

 

Fair

 

NotQuiet&hastendencytocrying

 

3

 

Poor

 

Cryingandstressful

 

4


Table 3. Response to inhalational induction by mask 

 

Scores

 

ResponsetoMaskandinduction

 

1

 

Irritable,crying

 

2

 

Fearfrommask

 

3

 

SlightCooperative

 

4

 

Calm

 

5

 

Asleep

Fifty pediatric patients with ASA physical status 1-II (age 1-8 year) were scheduled for circumcision, hernia repair, hypospadias repair and were assigned to receive oral premedication with midazolam (0.3-0.4 mg kg, group M, n = 25) or hydralazine syrup (1mg/kg, group H, n =25) prior to a standardized sevoflurane anaesthetic level of sedation.

Vital signs (blood pressure, breathing rate, pulse and oxygen saturation) and behavior parameters (consciousness, crying, movement, overall behavior) were evaluated every 5 minutes after premedication.

All children received EMLA cream before IV placement, then were taken to the waiting area in the presence of parents and observed for 30 min before operation. Sedation score, vital signs and behavior scores were noted and then the patients were shifted into the operating theatre and the response to parent’s separation was noted.

Before induction was started using the face mask (with 75% oxygen mixed with nitrous oxide and sevoflurane 8%) ECG, Spo2, NIBP monitors were applied and the response to induction with inhalation anesthesia via mask acceptance was noted. I.V. line was secured and fluids with a 3 ml/kg/h rate, after a prior bolus of 100-150ml, were given to compensate the period of fasting hours. Fentanyl 1µg/kg and Propofol 2 mg/kg were given. Laryngeal mask airway (LMA) was used for secured airways and after its fixation, Paracetamol suppositories 20 mg/kg and Diclofenac supp. 1mg/kg were administrated unless contraindicated.

For hypospadias repair, caudal epidural block was performed with 0.5 ml /kg of 0.2% ropivacaine, penile and ring block was used for circumcisions and local anesthetic infiltration given by surgeons for umbilical hernias repair. The operations lasted 20-80 minutes. The recovery was uneventful and the patient was shifted to PACU where vital signs, sedation scores and VAS scores were monitored.

After discharge to the pediatric ward, the parents and nurse were instructed to continue the evaluation for 4 houts of pain, sedation, postoperative nausea and vomiting (PONV) and sleep pattern. The family continued to observe them during another 24-h period. The parents and nurse were also asked for their preference concerning the postoperative behavior of their child (calm, sedated vs. alert, active).

Results

There were significant differences in Ramsay Sedation Score (RSS), response to parental separation and mask induction, or wake-up behavior score (Table 4). When compared with group H, patients in group M were significantly more cooperative, easy to separate from parents, with less anxiety and they accepted the mask in the operation room within 30 minutes after premedication (P value < 0.05 ).

Table 4Comparison of two groups

ChildrensResponses

 

Groupofmidazolam

 

Groupofhydroxyzine

 

P.value

 

Sedationscore

 

4

 

3

 

0.05

 

Separationresponse

 

2

 

3

 

0.05

 

Induction&maskresponse

 

4

 

2

 

0.05

Postoperative agitation was considered significantly lower in group M due to anterograde amnesia in comparison with group H. No statistically significant differences in the effect of medications on breathing rate, heart rate, blood pressure and oxygen saturation were showed when comparing group M and group H (Fig. 1).

Figure 1: Mean O2 saturation post premedication

a 1

In the present study both midazolam and hydralazine are safe for use in children but the study showed that the midazolam was preferred due to faster onset of sedation, calmness that can be easily aroused to full consciousness and also surgeons satisfaction. Several reactions have been noted with hydroxyzine use: deep sleep, incoordination, sedation, calmness, and dizziness.

Discussion

The concept of sedation in children is a big challenge for anesthesiologists, surgeons and parents. The purpose is to sedate the child before surgical treatment so it can easily be separated from its family and to accept inhalational anesthesia. Midazolam proves to be a good anxiolytic agent [3] but also amnestic, short-acting hypnotic, regularly used as potent premedication due to its rapid oral absorption [3], with half- life of 13 min, peak plasma concentration at 1.25 hours and elimination half-life at 2.3 hours [8].

Anterograde amnesia is the lack of recall of events occurring from time of administration of a drug by impairment of the ability to acquire new information [5]. M.F Levine et al. determined in their study the minimum time interval (about 10 minutes) required between oral intake of midazolam and the safe separation from family [7].

Hydroxyzine has a slower onset but with a longer duration of action [8]. This study showed significantly different levels of sedation, quietness, and tolerance to mask preinduction in the 2 groups in the first 30 minutes from application of the drugs. The group with midazolam appeared more quiet otherwise there was no difference between the two groups in level of sleepiness or parental separation. The amnestic effect was clear in the midazolam group.

Saad A.Sheta et al. supported that premedication with midazolam 0.5-0.75 mg/kg is effective and the tolerance for mask induction is 45-75% [6]. Postoperative behavior was minimally affected especially with good postoperative analgesia whether per os, penile, ring or caudal epidural block or infiltration of wound by local anesthetics.

The differences found in overall behavior between the midazolam group and the group of hydroxyzine, were statistically significant and clinically relevant. Midazolam showed better effectiveness than hydroxyzine especially when related to quiet behavior (separation from parents and good tolerance to mask induction) [9]. Upon evaluation of the safety aspect of midazolam and hydroxyzine, both protocols were found to be safe. Chaudhary et al. concluded that midazolam was found to be a better premedication in terms of sedation, anxiolytic and safety when compare to triclofos or hydroxyzine [9]. Kazak et al. have shown that midazolam also in small doses - 0.25 mg/kg with the presence of children’s parents or 0.5mg/kg without their presence produces good sedation effects [10]. Parameswari et al. confirm that midazolam as premedication was superior and the children accepted the face mask better than other drugs [11].

Conclusion

By summarizing the above comparison, we can conclude that midazolam has more sedative, anxiolytic, amnestic effects and decreased postoperative agitation which may be caused by sevoflurane and it is safer to use as premedication in pediatric patient undergoing general anesthesia.

 

 

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