|Year : 2022 | Volume
| Issue : 6 | Page : 531-542
Behavioral outcome of oral midazolam premedication in pediatric dental general anesthesia: A systematic review
Abdul Rauf Badrul Hisham1, Farah Najihah Mohamad2, Iza Nabihah Ali3, Nik Rozainah Nik Abdul Ghani4, Wan Muhammad Amir Wan Ahmad5, Norsamsu Arni Samsudin6
1 Pediatric Dentistry Unit, School of Dental Sciences, Universiti Sains Malaysia (USM), Kota Bharu, Kelantan, Malaysia; Kudat Dental Clinic, Ministry of Health (Malaysia), Kudat, Sabah, Malaysia
2 Kudat Dental Clinic, Ministry of Health (Malaysia), Kudat, Sabah, Malaysia
3 Senggarang Dental Clinic, Ministry of Health (Malaysia), Batu Pahat, Johor, Malaysia
4 Conservative Dentistry Unit, School of Dental Sciences, Universiti Sains Malaysia (USM), Kota Bharu, Kelantan, Malaysia
5 Unit of Biostatistics, School of Dental Sciences, Universiti Sains Malaysia (USM), Kota Bharu, Kelantan, Malaysia
6 Pediatric Dentistry Unit, School of Dental Sciences, Universiti Sains Malaysia (USM), Kota Bharu, Kelantan, Malaysia
|Date of Submission||25-Jul-2022|
|Date of Acceptance||28-Sep-2022|
|Date of Web Publication||30-Dec-2022|
Dr. Norsamsu Arni Samsudin
Pediatric Dentistry Unit, School of Dental Sciences, Universiti Sains Malaysia (USM), Health Campus, 16150, Kubang Kerian, Kota Bharu, Kelantan
Source of Support: None, Conflict of Interest: None
Aim: This systematic review explores the postoperative behavior outcomes of oral midazolam (OM) premedication in pediatric dental general anesthesia (DGA). Premedication drug assists in the reduction of negative psychological impact during the general anesthesia induction, thus influence the behavior, particularly in pediatric patients. OM is one of the common premedications given due to its efficacy and well accepted administration. Materials and Methods: This review was registered under the International Prospective Register of Systematic Reviews (PROSPERO). Studies published in the databases including PubMed Central, Cochrane, Web of Science, Google Scholar and others between January 1980 and December 2020 were analyzed using Preferred Reporting Items for Systematic Review and Meta‐analysis (PRISMA) guidelines. Risks of bias and evidence levels were determined on each selected study. Results: Seven out of 6944 studies, were scrutinized for final analysis, which involved a total of 392 children in experimental groups and 89 children in placebo groups. OM had shown both positive and negative behavior outcomes post DGA using different assessment tools, in comparison to other premedications. It also showed less side effect post consumption. Conclusions: OM premedication demonstrated very limited evidence for positive behavior outcomes in pediatric DGA. The 0.5 mg/kg body weight dosage of midazolam yields the most favorable behavior postoperatively. Based on this collective review, there is still limited evidence for positive behavior outcomes in OM premedication.
Keywords: Behavior, Dental General Anesthesia, Oral Midazolam, Pediatric, Premedication
|How to cite this article:|
Hisham AB, Mohamad FN, Ali IN, Nik Abdul Ghani NR, Wan Ahmad WA, Samsudin NA. Behavioral outcome of oral midazolam premedication in pediatric dental general anesthesia: A systematic review. J Int Oral Health 2022;14:531-42
|How to cite this URL:|
Hisham AB, Mohamad FN, Ali IN, Nik Abdul Ghani NR, Wan Ahmad WA, Samsudin NA. Behavioral outcome of oral midazolam premedication in pediatric dental general anesthesia: A systematic review. J Int Oral Health [serial online] 2022 [cited 2023 Nov 30];14:531-42. Available from: https://www.jioh.org/text.asp?2022/14/6/531/366430
| Introduction|| |
Managing uncooperative children is one of the exciting challenges for a dental professional. Children who are dentally anxious and exhibit fearful responses like crying and violent movements would cause difficulty in commencing dental treatment in the dental clinic. There are two types of behavior management techniques in managing challenging behavior among children. The first type is non-pharmacological behavior management, including tell-show-do, communication and communicative guidance, voice control, positive reinforcement, nonverbal communication, distraction, and parental presence or absence., In cases of pronounced uncooperative children or when the former non-pharmacological technique failed, pharmacological behavior management is recommended using nitrous-oxide inhalation, oral or intravenous sedation, and general anesthesia.,,
Dental general anesthesia (DGA) cases have increased in service demand over time, with early childhood caries being the common preoperative diagnosis among pediatric patients. Regardless of its risks, parental acceptance is high for pharmacological behavior management during dental treatment for their children, including inhalation sedation and DGA. In DGA, preoperative conditions can be difficult and stressful for most patients, particularly those readily anxious and uncooperative children. Parental separation anxiety and physical restraint during induction of anesthesia might increase the risk of additional psychological trauma in children. As a result, it makes it harder to induct masks in the operating room, increases pre- and postoperative discomfort and causes recovery psychology and behavior issues. Thus, premedication is suggested before DGA in uncooperative children to improve preoperative and postoperative outcomes.
Premedication involves using drugs to reduce anxiety and disruptive behavior before any procedure, which can be administered via multiple routes such as oral, intravenous, intramuscular, rectal, and nasal routes. Premedication drugs commonly used in pediatric patients include midazolam, lorazepam, chloral hydrate, ketamine, clonidine, and others. Oral midazolam (OM) is an imidazole benzodiazepine derivative. It is most common premedications used in managing pediatric patients for its easy administration, rapid and reliable onset, anterograde amnesia effects and minimal risk of respiratory depression.,,,
Apart from the preoperative anxiety, children also tend to exhibit various negative postoperative behavior as a result of general anesthesia and hospitalization. It has been suggested that there is an interchangeable confounding factors on each component of postoperative maladaptive behaviors, preoperative anxiety, and emergence delirium, with parental influence and patient’s preoperative anxiety level. Emergence delirium (ED) or emergence agitation is an acute recovery state from general anesthesia; which patients may exhibit disorientation, restlessness, hallucination, and hyperactive physical behavior. In the last decade, most studies focused on the quality of life in pediatric patients undergoing DGA which involves few days post DGA., Nevertheless, to our limited knowledge, there is limited data regarding the effect of OM premedication on the behavior outcome post DGA in pediatric patients. Thus, this systematic review was aimed to identify the effect of OM premedication on postoperative behavior outcome in pediatric DGA. The comparison of postoperative recovery behaviors with other premedication drugs was also evaluated.
| Materials and Methods|| |
Protocol and registration
This study was based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline and under the International Prospective Register of Systematic Reviews (PROSPERO) registration of National Institute for Health Research (NIHR), University of York (ID: CRD42021226985).
A comprehensive search was performed independently by three reviewers. PubMed Central, Cochrane, Web of Science, Google Scholar, Science Direct, Latin American and Caribbean Health Sciences Literature (LILACS), Excerpta Medica Database (EMBASE), OpenGrey, EBSCO, and Library Genesis databases were searched from their inception to December 2020. The similar retrieval strategy applied for each database using keywords “pediatric/pediatric,” “children,” “oral midazolam,” “premedication,” “behavior/behavior” and “dental general anesthesia/anesthesia.”
The following research question was established by PICO analysis:
P (patient): pediatric patients aged below 18 years old who received DGA
I (intervention): OM as premedication either single drug or combination with other drugs
C (comparison): control group or other drugs as premedication sedation
O (outcome): Immediate postoperative outcome, behavior outcome, side effect
The selected study had used OM premedication, either as a single drug or combination with another drug. It involved the children who received DGA under the aged of 18 years. It must be in full published English version, including prospective, retrospective, and randomized controlled trials (RCT) studies. The reported result had included at least one postoperative behavioral outcome.
Studies that had used OM premedication in conscious sedation and other medical procedures were excluded. Expert opinions, mini-review, systematic review, literature review, and animal studies and articles from predatory journal according to Beall’s List also were not selected for this review.
Data extraction and management
Data extraction and management process are shown in [Figure 1]. Each database’s literature search results were imported into Microsoft Excel, where they were checked for duplications. The material in the titles and abstracts was then scrutinized based on the inclusion and exclusion criteria. If the abstracts and titles were pertinent, the complete texts of the publications were collected. Two reviewers then evaluated the selected studies. Data were extracted from the selected eligible studies, which included the study characteristics (publication year, country, and type of studies), participant characteristics (age, dental treatment received, and number of participants involved), treatments (drug used, administration route, dosage) [Table 1], behavior assessment tool used, postoperative behavior outcomes and side effects of premedication drug [Table 2].
|Figure 1: Preferred reporting items for systematic review and meta-analysis flow chart of study design|
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|Table 2: Perioperative and postoperative behavior status and side effects|
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Study quality assessment
The selected study quality was evaluated using an assessment tool that corresponded with its study design and was performed independently by three reviewers. This was followed by a discussion with the other reviewers to resolve any disagreement in selection process, data extraction, and study quality assessment until an agreement was achieved.
Randomized clinical trials (RCT) were assessed for risk of bias using RoB 2 as described in the Cochrane Collaboration’s tool. The assessment items are randomization method, missing outcome data, intervention deviations, outcomes measurement and reported result selections as in Appendix 1, which rated as “High risk of bias,” “Low risk of bias,” or “Unclear risk of bias” for each item. Newcastle-Ottawa scale (NOS) with the total score ranging from 0 to 9, was used to assess the retrospective cohort study (RS). As for the final part of study assessment, the Oxford Centre for Evidence-Bases Medicine recommendation (OCEBM) tool was used to determine the level of evidence level for each study.
| Results|| |
Result of literature search
The primary identification resulted in a total of 6946 citations, which later 5365 of those were excluded due to criteria such as irrelevant articles and duplicate version. Seven full text studies were selected for the final review and assessment. From the seven studies, six studies were randomized controlled trial studies,,,,, and one retrospective study that involved a collective sample size of 392 and 89 children in the experimental and placebo groups, respectively. For the randomized controlled clinical studies, four were double-blinded,,, and two were single-blinded., Two studies were conducted in India, and one each in China, Iran, United Kingdom, Sweden, and Turkey.
Midazolam alone was administered through different routes in 236 children: (1) Oral dosage of 0.4 to 0.5 mg/kg body weight,,, (2) Rectal dosage of 0.3 mg/kg and (3) Transmucosal dosage of 0.2 mg/kg. Oral ketamine with dosage of 5 mg/kg and oral butorphanol with dosage of 0.2 mg/kg were administered in 10 and 30 children, respectively. A total of 56 children were administered dexmedetomidine alone. The various routes of administration were orally with dosage of 2μg/kg in 26 children and intranasally with dosage of 2 μg/kg in 30 children. Hosey et al. compared transmucosal midazolam with dosage of 0.2 mg/kg with placebo. Jessen and Matsson compared two different doses of midazolam: (a) with dosage of 0.4 mg/kg orally and (b) with dosage of 0.3 mg/kg rectally. Mehran et al. administered the same dose of OM with dosage of 0.4 mg/kg in combination with different drugs; chloral hydrate with dosage of 50 mg/kg and promethazine with dosage of 5 mg/kg. There is limited comparison between studies, meta-analysis cannot be done due to study design heterogeneity.
Based on RoB 2 analysis, all the RCTs selected had a “low risk of bias”. The score was five by using NOS. In this review, most studies were ranked as Level 1b based on the OCEBM evidence [Appendices 1 and 2]. This means that the studies were categorized as individual RCT with narrow confidence intervals, more than 80% follow up for prognosis, and validated study with good reference standards.
Postoperative behavior outcome
[Table 2] presents the postoperative behavior outcomes of all the included studies by using respective assessment tools. Three studies demonstrated better effects of other drugs, such as dexmedetomidine, and butorphanol rather than OM. Pediatric Anesthesia Emergence Delirium Scale (PAEDS) was used as an assessment tool for evaluating children’s postoperative behavior status., The PAEDS assessment involves five psychometric items: (1) Eye contact of child with the caregiver, (2) Purposeful child’s actions, (3) Awareness of the child with of his/her surroundings, (4) Restlessness of the child, (5) Inconsolable child. Resultantly, the absence of emergence delirium in dexmedetomidine group was reported in both, while emergence delirium occurred in the OM group, with five (19.2%) and six (20%) children respectively.
Singh et al. assessed post anesthesia recovery within 24 hours postoperatively following parameters in the questionnaires; (a) Awakening time, (b) Requirement of jaw thrust, (c) Nausea/Vomiting, (d) Crying, (e) Psychomimetic behavior, (f) Involuntary motions, (g) Restlessness, (h) Nocturnal enuresis, (i) Full amnesia and (j) Recollection of operation theatre surrounding, intravenous line puncture, anesthesia induction and pain. More children experiencing involuntary motions postoperatively in the oral butorphanol group (n = 1, 3.3 %) rather than none in the OM group %). They cried more in the OM group (n = 15, 50%) than the oral butorphanol group (n = 6, 20%).
Hosey et al. used the Revised Rutter Scale for School-Age Children, which describes parental ratings on the children’s behavioral and emotional struggling. They concluded that total Rutter score had significant effect (p = 0.048) in general, with children aged 8 years and above in OM group showed improvement at week one post DGA compared to preoperative baseline score. Nevertheless, no significant difference was observed as a function of premedication in behavior assessment by using the above mentioned assessment.
In contrast, Damle et al. used a questionnaire about the children’s and parents’ surgical experience, as well as the side effects experienced by the child during check-up the following day postoperatively. The questionnaire consists of A) Child’s preoperative experience: Pleasant / Acceptable / Unpleasant B) Parents’ assessment of child’s surgical experience Pleasant / Acceptable/ Unpleasant C) Child asked if he remembered ‘going to sleep’: Yes / No D) Any side effects observed? No side effects / Nystagmus (twitching of eyes) Nausea / Vomiting / Behavioral changes / Other. The midazolam group demonstrated better effects as (n = 8, 80%) of the children had a ‘pleasant experience’ compared to the ketamine group (n = 1, 10%). In OM group showed fewer side effects; 90% of the children had none, whereas five (50%) children in oral ketamine group had vomiting, and one (10%) exhibited behavioral changes – hallucinations.
Mehran et al. assessed child’s behavior rating using Wilson’s Sedation scoring system that scored into Interrupting, Bad, Not Bad, Good, and Excellent behavior. Using this scale, Mehran et al. evaluated children’s post-operative cooperation and found that the OM with chloral hydrate group induced better and significant effect (P < 0.001) than the OM with promethazine group.
Jessen and Matsson assessed the amnesic effect in children who received either oral or rectal midazolam. The first part involved the parent showed pictures of balloons in three different colors to the child as a memory cue on the day after DGA. At a week postoperative recall visit, the second part involved the child being shown pictures of three different toys. The child would point out the toy that he or she chose prior entering the operation theatre. The last part involved the assessment of acceptance level during tooth prophylaxis using a rotating rubber cup. Conversely, no significant differences in oral and rectal midazolam were reported, and children showed more acceptance during tooth prophylaxis procedure in the recall visit. However, OM group showed more favorable whereas 17 (68%) children remembered the color of the balloon than 14 (56%) children in rectal group. 10 (40%) children in OM group and 6 (24%) children in rectal group identified the right toy. Approximately 20 (80%) children in OM group and 17 (68%) children in rectal group showed positive acceptance level during the tooth prophylaxis.
Side effects of premedication
Damle et al. reported that vomiting and hallucination occurred in five children (50%) and one child (10%), respectively, in the group administered ketamine orally at 0.5 mg/kg, whereas only one child (10%) reported vomiting in the OM group. Six children experienced agitation (20%) in the OM group with 0.5 mg/kg dose. Nonetheless, four studies did not mention any side effects.,,,
| Discussion|| |
The present study aimed to review the existing evidence on the behavioral outcomes of OM as premedication in pediatric DGA. When children are undergoing medical procedures, they exhibit a variety of behaviors; some of these behaviors are supportive, while others are unpleasant. It is necessary to identify the range of behaviors that are indicative of children’s distress. There are few measurements used to evaluate behavior or sedation outcomes, such as Houpt behavior rating scale, Modified Houpt, Dichotomous behavior scale, Ohio State University behavior rating scale, Venham scale, Ramsay sedation scale, Acceptance of treatment by Holst, Frankl behavior rating scale, Modification Barker sedation scoring system, Global rating scale of overall behavior, and Briekopf and Buttner emotional status scale.
The OM administration of 0.5 mg/kg body weight is a common dosage and routinely prescribed as premedication in children,,,, because it provides effective sedation, good parental separation behavior, and satisfactory induction mask acceptance in children who underwent DGA. Midazolam is also commonly used as a premedication through intravenous (IV), intramuscular (IM), oral, rectal, and nasal routes of administration.
Damle et al. reported a more favorable post-behavior outcome in the OM group with a 0.5 mg/kg dosage. A systematic review of OM for minimum and moderate sedation level in pediatric patients reported that OM yielded better outcomes compared with placebo when both are used as premedication before GA (0.5 to1.0 mg/kg). The oral route produces comparable response rates as intranasal (0.3 mg/kg), sublingual (0.3 mg/kg) and rectal (0.5 mg/kg) routes. No significant difference in selected routes of midazolam administration, except that rectal administration is more favorable for better sedative effect. OM premedication in tonsillectomy procedure under general anesthesia yielded better effects in managing children’s anxiety more than parental presence alone. Midazolam is most given orally,,,, and it is combined with various agents, such as honey, flavored juice, and paracetamol syrup to boost savouries and acceptance of the midazolam consumption., Hosey et al. reported a reduction in dental anxiety postoperatively in children who had been given transmucosal midazolam premedication.
Wang et al. compared premedication of 0.5 mg/kg OM and intranasal midazolam with 2 μg/kg dexmedetomidine, resulting in a 20% incidence of agitation in the midazolam group. Post DGA complications seem to be more common in children. A study in Turkey reported that 69.9% of children had one or more complaints after one day post DGA, which included coughing, dental pain, limitation in eating, psychological differences, and sore throat in 36 (27.1%), 36 (27.1%), 33 (24.8%), 32 (24.1%), and 28 (21.2%) children, respectively. Farsi et al. showed children had complaints on day 1 post DGA; problem in eating, sleepiness, dental pain, oral bleeding, drowsiness, sore throat, vomiting, psychological differences, and fever. Hu et al. proved that dental pain was the most common post DGA morbidity on day 0, day 1, and day 3 in 46 (82%), 46 (82%), and 22 children (39%), respectively. Chorney et al. reported a wide range of distress and non-distress behaviors in children post general anesthesia such as verbal pain, crying, verbal resistance, and nonverbal support request. These events demonstrated a relationship between the analgesic used during general anesthesia and postoperative pain scores.
A high proportion of the children (64%) subjected to an oral dose of 0.4 mg/kg OM experienced drowsiness, whereas no significant difference when comparing the oral and rectal administration routes. In another study, a stronger sedative effect was reported following the rectal administration of midazolam. Nevertheless, it is strongly recommended that to monitor the side effects during recovery period before discharging the patient.
Oral preparation mixture of premedication drug with certain drinks might affect the drug’s pH and absorption rate, thus the effectiveness of those drugs. In this current review, multiple drinks had been used as mixture in order to increase the acceptability during the oral intake among children. It is difficult to compare the effectiveness of premedications towards positive or acceptable behavior outcome post DGA due to variety in methodology applied in each study.
The limitations in this review are well acknowledged. Grey literatures were not retrieved. Only English published studies were included. The behavioral effects of OM premedication in children who had undergone DGA have not been widely studied. Most studies focused on medical procedures or used other routes of midazolam administration. Hence, a meta-analysis review could not be performed as the selected studies were not homogenous and each involved different drug comparison, dosage and routes of administration. Additionally, various tools were used in determining behavioral outcomes of premedication including OM, and some studies excluded post-behavioral outcome assessment.
| Conclusion|| |
Conclusively, this review suggests OM premedication provided very limited evidence for positive behavior outcomes in pediatric DGA. Although oral administration is less invasive, the bitter taste of midazolam is profoundly unpalatable to most children. It has been shown that OM with dosage of 0.5 mg/kg body weight exerts a positive effect in children undergoing DGA and effectively improves their postoperative behaviors. An adequate peri- and postoperative supplement analgesia is highly recommended to prevent postoperative distress. In order to find an ideal premedication, more future studies with larger sample size are needed to investigate the effect of OM premedication in pediatric DGA. Better assessment and observation post DGA is also necessary to provide concrete evidence to validate this matter and improve postoperative pain management in children.
- ♦ Scientific rationale for the study: The use of OM as premedication in children who are undergoing DGA to improve recovery behavior is still limited in evidence-based data.
- ♦ On behavior outcomes are insufficiently clear to provide definite recommendations in clinical practice.
- ♦ Principal finding: The 0.5mg/kg bodyweight of OM gives more positive recovery behavior post DGA, despite a few reported side effects.
- ♦ Practical implication: Oral premedication, such as midazolam is known to be less invasive to be administered preoperatively, even though it is not routinely prescribed in our current practice as part of standard operating procedure prior general anesthesia. This review revealed limited evidence regarding the use of premedication OM, including comparison with other premedication drugs as to improve the recovery behavior in pediatric DGA.
Recommendation on applicable observational tools in pediatric DGA [Appendix 3].
The authors are thankful to members of the Pediatric Dentistry Unit, School of Dental Sciences, Universiti Sains Malaysia, and Ministry of Health Malaysia.
Financial support and sponsorship
This work was supported by Universiti Sains Malaysia short term grant 304/PPSG/6315338. This study registered under the International Prospective Register of Systematic Reviews (PROSPERO), National Institute for Health Research (NIHR), University of York (ID: CRD42021226985). https://www.crd.york.ac.uk/prospero/ display_record.php?RecordID=226985
Conflicts of interest
There are no conflicts of interest.
ARBH and NAS: Study conception.
ARBH, FNM, and INA: Data collection.
ARBH, FNM, INA, and NAS: Data acquisition.
ARBH and NAS: Data analysis.
ARBH and NAS: Data interpretation.
ARBH, FNM, and INA: Risk-of-bias assessment.
ARBH, NAS, and WMAWA: Manuscript writing.
NRNAG, WMAWA, and NAS: Revision of paper for critical intellectual content.
All the authors approved the final version of the manuscript for publication to be mentioned.
Ethical policy and institutional review board statement
Patient declaration of consent
There is no patient declaration of consent.
Data availability statement
The data set presented within this article has been obtained from 7 review articles. The data were readily available within the articles.
| Appendix 1: Risk of bias of clinical trial studies using revised Cochrane risk of bias tool for randomized trials (RoB2) and level of evidence (OCEBM)|| |
| Appendix 2: Risk of bias using the Newcastle–Ottawa Quality Assessment Scale level of evidence (OCEBM)|| |
| Appendix 3: Recommendation on applicable observational tools|| |
An evaluation of children’s behavior post DGA is critical. A few methods that can be used in further studies with larger samples recording behaviors pre-and post-operative DGA.
a) Houpt and Modified Houpt Rating Scale, Houpt et al.
b) Ohio State University Behavioral Rating Scale (OSUBRS)
Ohio State University Behavioral Rating Scale (OSUBRS) is categorized into four groups to measure children’s disruptive behaviors. This scale generally observes patients and categorizes them into either quiet, crying without movement, movement without crying, or struggling.
c) Frankl’s Behavior Rating Scale
Frankl’s behavior rating scale (FBRS) was developed in 1962 and to date, it is commonly used by dental practitioners and researchers. It categorized behavior into four groups according to children’s attitudes. Nonetheless, this classification evaluates the behavior of children without relying on specific criteria. Later in 1975, Wright modified Frankl’s behavior rating scale (FBRS) with additional symbols. As suggested by AAPD, it was categorized into four groups: definitely positive (++), positive (+), negative (−), and definitely negative (--) as shown below.
d) Venham Behavior Rating Scale
This scale used six categories in the cooperative behavioral scale, which is also called the uncooperative behavior rating scale. Each category explains in detail the child’s behavior and provides information regarding their negative behaviors., ranging from 0 to 5 with higher scores indicating greater levels of children’s disruptive and negative behavior.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], [Table 9]