| Background: Minor laceration in maxillofacial region is a common disease in pediatric stomatology emergency department,our emergency medical system has formulated a reliable and effective service to deal with these patients in condition that patient could cooperate.However the preschool and lower-grade students might not keep immobile and quiet during treatment because of anxiety and fear,which poses a huge challenge to emergency dentist.Dentists used to perform medical procedure with the assistance of papoose board or general anesthesia.Both methods pose disadvantages.With the development of society,there are increasing requirements for this emergency services.Objective: Part I: To evaluate the safety,efficacy and reliability of IM.(intramuscular midazolam)0.2mg/kg in maxillofacial laceration repair in pediatric stomatology emergency,and to verify the feasibility of clinical application of this sedation protocol.Part I I: To compare the clinical applicability of sedation protocols of IM(intramuscular midazolam)0.2mg/kg with IN.(intranasal midazolam)0.3mg/kg in maxillofacial laceration repair in pediatric stomatology emergency,in terms of sedation onset,recovery time,HOUPT score,adverse reactions,and impact on basic physiological index.Methods: Part Ⅰ: From January 1,2022 to June 30,2022,patients aged 3-9 with maxillofacial laceration,who could not cooperate and be scored 1 or 2 using Frankl scale,were recruited.After guard signing the informed consent form,a suitable picture was showed until the patient remembered the picture.All patients were sedated by intramuscular midazolam 0.2 mg/kg.When patients were scored 2 or greater using the RASMAY scale,the resident performed the procedures.After procedures,the resident transferred the patient to recovery room and rated the procedures with HOUPT scale.The attending doctor took care of patients and record the potential adverse effects until they reached the discharge criteria.In addition,vital signs including Sp O2(oxygen saturation),HR(heart rate),BP(blood pressure)were recorded at pre-sedation,preoperation,post-operation,and pre-discharge four time points.Within 48 hours,a follow-up phone call was made to record any adverse reactions.The legal guardian was required to complete the satisfaction questionnaire when the patient returned for a follow-up visit within 7-10 days.The HOUPT score was set as our primary measurement,and onset time,recovery time,anterograde amnesia,adverse reactions,and operation time were also assessed.Part II: From July 01,2022 to January 01,2023,the patients were engaged with the part I selection criteria and randomly divided into two groups,group IM.: intramuscular midazolam 0.2mg/kg,and group IN.: intranasal midazolam 0.3mg/kg.The procedure and outcomes were consistent of part I.Results: Part Ⅰ: A total of 20 cases were included in this part,the Sp O2,HR,and BP during the procedure were within the normal physiological range.Among them,the blood oxygen increased slightly after sedation.The HR increased after sedation and decreased after the operation;Systolic blood pressure fluctuates slightly after sedation,rising first and then falling.The onset time,operation time and recovery time were12.95±3.620 min,14.80±8.788 min,13.15±5.334 min,respectively.HOUPT score was5.30±0.923.Before discharge,nine patients(45%)failed in the memory assessment.Two patients showed adverse reactions,and a total of 6 adverse reactions were reported at follow-up.Part II: 66 cases were recruited and divided randomly into the Group IM and Group IN for analysis and there were no significant differences in demographic and scale indicators including gender,age,body weight,ASA classification,and Frankl score between the two groups(P>0.05).Among vital signs including the Sp O2,HR,and BP,the diastolic blood pressure of Group IN was greater than that in Group IM when pre-sedation(69.42±9.05 mm Hg vs.63.39±4.97 mm Hg),when pre-operation(67.55±9.68 mm Hg vs.63.52±8.09 mm Hg),and when post-operation(67.94±12.62 mm Hg vs.61.76±10.05 mm Hg);the systolic blood pressure of Group IN was greater than that in Group IM when post-operation(112.06±13.92 mm Hg vs.105.03±11.42 mm Hg),and when pre-discharge(108.39±10.49 mm Hg vs.103.24±8.57 mm Hg).The onset of sedation was 13.39±3.17 min in Group IM and13.33±2.74 min in Group IN.The operation time was 15.21±8.47 min in Group IM and16.06±9.53 min in Group IN.The median HOUPT score was 5.12±0.89 in Group IM and 5.03±1.05 in Group IN,and the sedation success rate in both groups was 90.9%.The incidence of adverse reactions in Group IM and Group IN before and after discharge were 15.15%,42.42%,and 15.15%,24.24%,respectively.The recovery time was 11.70±4.57 min in Group IM and 13.48±3.67 min in Group IN.There were no significant statistical difference between the groups in terms of primary and others outcomes(P>0.05).27(81.82%)in Group IM and 30(84.85%)in Group IN were satisfied with sedation procedures,and there was no statistically significant difference(P>0.05).Conclusion: Intramuscular midazolam 0.2 mg/kg can provide rapid,safe,and reliable sedation effect in patients.The sedation protocols of intramuscular midazolam0.2mg/kg and intranasal 0.3mg/kg can provide sufficient sedation for laceration repair to promote completion of treatment without serious complications.These two sedation protocols could complement each other,so pediatric emergency dentists could choose a suitable sedation protocol according to the actual situation. |
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