A logistic model to predict the rates of emergence agitation in pediatric patients after a cleft lip or palate surgery: a prospective study

doi:10.21203/rs.3.rs-2729721/v1

Objectives:

To predict the occurrence rates and related factors that can lead to Emergence agitation (EA) among pediatric patients after a cleft lip or palate surgery.

Materials and Methods:

A prospective study was performed to analyze the influencing factors of EA amongst pediatric patients after cleft lip or palate surgeries. The cohort data were collected in the department of oral and maxillofacial surgery of a tertiary stomatological hospital in Chengdu, China, in which patient's demographic variables, monitorization recording of the patient's anesthesia and post-operative situations, and postoperative restlessness assessment records, etc were included.

Results:

One hundred ninety patients who aged from 3 months to 6 years old, underwent cleft lip/palate repair surgeries and were under general anesthesia participated in this study voluntarily. And this process was conducted from June 2020 to October 2020. The univariate analysis showed that the occurrence of EA was affected by weight, age, fasting duration, operation duration, anesthesia duration, usage of iodoform, and level of pain (p < 0.01). Logistic regression showed that age, fasting duration, operation duration, and level of pain influenced the occurrence of EA (p < 0.05).

Conclusions:

Age, operation duration, fasting duration, and level of pain could predict the occurrence of EA among postoperative pediatric patients.

Clinical Relevance:

EA impacts the safety of post-surgery pediatric patients under general anesthesia significantly. Age, operation duration, fasting duration, and level of pain could predict the occurrence of EA among postoperative pediatric patients.

Cleft lip

cleft palate

Emergence agitation

General anesthesia

Post-anesthetic care unit

Cleft lip and palate, which was defined as structural or functional craniofacial abnormalities that existed at birth, was one of the most common congenital craniofacial deformities with an occurrence rate of nearly 1/700 live births in the world, while as high as 1/500 in Asians and Amerindians [1, 2]. Cleft lip and palate can not only affect the development of maxillofacial and dentoalveolar but also can cause dysfunctions such as sucking, swallowing, speech, self-esteem, and social behavior [3, 4, 5]. Therefore, rehabilitation for cleft patients is a challenge. Most of the time, interdisciplinary sequential therapy was needed, as a result, surgeries were the most critical part [6]. Although the surgical treatment could repair the maxillofacial deformity and improve the function of children with cleft lip and palate to the greatest extent, certain complications associated with surgeries were still very unfavorable [7, 8].

Emergence agitation (EA) after cleft lip and palate surgery was a common complication for healthcare professionals to handle. Eckenhoff et al were the first to describe this post-anesthetic EA, which manifested as crying, sobbing, thrashing about, and being disoriented [9]. Currently, EA is also characterized by non-purposeful movement, restlessness, agitation, disorientation, hallucination, delusion, inconsolable crying, and cognitive impairment [10, 11, 12]. Bleeding, wound dehiscence et al., poses additional risks to patients, to parental dissatisfaction with any additional treatments, and to care burden for medical staff [13, 14, 15]. Some studies argued that EA was attributed to different factors such as volatile anesthetics, type of surgery, pain level, age, etc [15, 16]. Another study showed that EA occurred as a result of severe pain due to insufficient analgesia. Still, there was study shows that even pain-free children with a caudal block would become agitated during the emergence period of anesthesia [17]. Therefore, the cause and influencing factors of EA were not clear, especially since there were no definite influencing factors of EA during the recovery period of general anesthesia, not to mention children with cleft lip and palate.

Therefore, this study aims to analyze the influence factors of the EA occurrence amongst the post-cleft lip/palate surgery pediatric patients population to provide references for later interventions for EA.

Study design and patient selection

The cohort was collected in the Department of Oral and Maxillofacial Surgery of a tertiary stomatological hospital in Chengdu, China. One hundred ninety patients aged from 3 months to 6 years old who underwent cleft lip or palate repair surgeries under general anesthesia participated. This study was conducted from June 2020 to October 2020. The Institutional Ethics Committee approved this project, and the number was WCHSIRB-CT-2020-211-R1.

Strict inclusion and exclusion criteria were settled in this study. The inclusion criteria: ①we selected the patients undergoing cleft lip or cleft palate repair surgeries under general anesthesia; ②The patients aged 3 months to 6 years old and weighed more than 5 kg; ③All scoring grades of the American Society of Anesthesiologists (ASA) were Ⅰ~III; ④Prior written and informed consent of caregivers was taken for inclusion in the study. While exclusion criteria were a patient who had a mental disease, neurologic disease, treatment with sedatives, severe heart defects, or patients who dropped out.

Study Setting

After the operation, the patient would be sent to the PACU immediately under close supervision from the anesthesiologist, surgeon, and transfer staff. On the arrival of PACU, essential monitoring of patients was applied immediately, including electrocardiogram scanning, pulse oximeter monitoring, and noninvasive blood pressure. Then, an assessment that close-related this study was conducted. Three parts were included in the assessment: the first was the demographic variables of the patients, for example, gender, nation, age, weight, diagnosis, feeding method, disease-related costs, etc. The second was monitorization of the patient's anesthesia and post-operative situations, for example, anesthesia method, anesthesia medication, anesthesia duration, operation duration, sequence of operations, postoperative usage of dressing and iodoform, level of pain, etc. We applied the Face, legs, activity, cry, controllability behavioral scale (FLACC Scale) to assess the pain level of patients under general anesthesia [18, 19]. The total score ranges from 0–10 points, and the higher the score, the more severe the pain [18, 19]. The reliability of the FLACC scale to children experiencing procedural pain was reported as almost perfect agreement with intraclass correlations ranging from 0.85 to 0.99 [20, 21, 22]. The third was the assessment of postoperative agitation. We calculated the EA score for every patient in the post-anesthetic care unit (PACU). The score of this assessment ranges from 1 to 5. For this assessment, score 1 indicates the patient is sleeping quietly, 2 indicates awake and calm, 3 means irritable and excitable, 4 means uncontrollable crying, and 5 is unable to be quiet, confused, and delirious [10, 11]. The patients will undergo agitation if they score from 3 to 5 on the 5-point scale, and the patients will need medication and care if they score 4 to 5 [10, 23]. The assessment will be applied once the child enters the PACU.

Statistical Analysis

We used SPSS 23.0 for data analysis. Interquartile spacing or percentage was used for statistical description, the Chi-square test and Fisher's exact probability method were used for univariate analysis, and Logistic regression analysis was used for multivariate analysis according to the data type, median.

Demographic variables

A total of 190 pediatric patients participated in the study. Their age was from 3 months to 6 years old. Of the 190 patients, 41.05%(n=78) had cleft lip, while 58.95%(n=112) had cleft palate. The nationality of a patient was mainly Han nationality and accounted for about 77.89% (148/190). The weight of the patients who were less than or equal to 10kg accounted for about 58.42% (111/190). The age of patients mainly was from 3-12 months and accounted for about 71.05% (135/190). The results were shown in Table 1.

Univariate analysis

The univariate analysis showed that the occurrence of EA was affected by weight, age, fasting duration, operation duration, anesthesia duration, usage of iodoform, and level of pain (p<0.01). Among them, the patients who weighed more than 10kg, were aged over 12 months, and had a fasting duration of more than 4 hours, an operative and anesthesia of more than 1 hour, a pain score of more than 3 points, and used the iodoform had relatively higher EA scores (p<0.05). The results were shown in Table 1 and Figure 1.

Binary logistic regression analysis

The binary logistic regression showed that age, fasting duration, operation duration, and level of pain influenced the occurrence of EA (p<0.05). Compared with the patients aged under 12 months, patients aged over 12 months had a higher occurrence of EA (OR=2.932, p=0.035). Compared with fasting duration ≤ 4 hours, fasting duration which exceeded 4 hours was one of the risk factors as well (OR=2.852, p=0.009). Compared with operation duration ≤ 1 hour, operation duration which exceeded 1 hour caused more EA (OR=3.013, p=0.0009). Compared with pain scores ≤ 3 points, pain scores more than 3 points were one of the risk factors for EA (OR=8.735, p<0.001). The predictive model calculated the risk of EA by the scores of the positive factors. For example, if a patient was over 12 months, the operation duration was 4 hours, the fasting duration exceeded 4 hours, and the pain score was 2 points, then the total was 22 points, so the risk rate of EA was 68%. The results were shown in Tables 2 to 3 and Figures 2 to 3.

There was a high risk of EA in patients with cleft lip or palate surgeries. Most studies reported the influencing factors of EA after general anesthesia. Mason (2017) reviewed the critical findings related to the proposed contributors to the EA from the literature, and found that volatile anesthetics, type of surgery, patient age, parental anxiety, patient anxiety, pre-existing patient behavior, and patient and parent interaction with healthcare providers were all influencing factors [16]. Sevoflurane-related agitation was reported as early as 1991, subsequently, the studies found that isoflurane, halothane, and desflurane would contribute to EA, but sevoflurane-related agitation had a higher propensity [24, 25, 26, 27, 28]. Each patient underwent sevoflurane inhalation anesthesia in our study, which contributes highly to agitation. A study reported that ophthalmology and otorhinolaryngology procedures have a higher occurrence of EA [29]. The type of surgery in our study was oral and maxillofacial procedures, mainly cleft lip or palate surgeries, which was another cause of high agitation. Studies also indicated that the occurrence of EA in children was much higher than that in adults [30, 31]. In our study, the age of patients, was mainly around 3–12 months, accounting for about 71.05%(135/190), which means the target population of this study was the high-risk population for EA.

Age, operation duration, fasting duration, and level of pain could predict the occurrence of EA among postoperative pediatric patients. The univariate analysis showed that multiple factors could affect the occurrence of EA amongst children with cleft and palate after general anesthesia, including weight, age, fasting duration, operation duration, anesthesia duration, usage of iodoform gauze, and pain scores(p < 0.05). For further analysis, the children who weighed more than 10kg, and aged more than 12 months, had a fasting duration of more than 4 hours, operative and anesthesia of more than 1 hour, usage of iodoform, and pain scores of more than 3 points had relatively higher EA scores (p < 0.05). The clinical practice found that children who used iodoform gauze packing in the operation room often had the characteristics of scratching the operation area with their hands after the surgery. We considered that it might be caused by the foreign-body sensation and iodoform odor irritation, which could also be a factor that caused agitation. Participants in this study were mainly infants and young children, especially those aged from 3–12 months (71.05%). Their daily feeding interval time was short, and each intake was not too much, if the fasting duration was over 4 hours, the occurrence of EA was relatively higher due to hunger which was challenging to express and control. However, an international multidisciplinary consensus statement on fasting pointed out that fasting did not guarantee an empty stomach, there was no observed association between aspiration and compliance with standard fasting guidelines, and the probability of clinically important aspiration during procedural sedation was negligible [32]. Therefore, we should re-examine the problem of fasting related to general anesthesia in children with cleft lip and palate. Studies showed that the younger the patient is, the greater risk of EA they will have [9, 16], which was inconsistent with the result of our study. This can be explained by the fact that participants in this study were from 3 months to 6 years old. In addition, the longer the operation and anesthesia time, the higher the EA scores. The direct factors related to the operation and anesthesia duration were the difficulty of the surgery, and the type of the surgery, when the surgery had a more serious difficulty, it also would have a higher occurrence rate of postoperative complications.

To further predict the influence of main variables on EA under general anesthesia amongst children with cleft lip and palate surgeries, binary logistic regression analysis was carried out. The result shows that age, fasting duration, operation duration, and level of pain were predictive factors of emergence agitation (p < 0.05). When the pain scores of patients were more than 3 points, their risk of EA was 8.735 times as high as patients whose pain scores were less than or equal to 3 points(p < 0.05). Therefore, the influence of pain on the occurrence of postoperative EA can not be ignored. The study reported that a large number of children did not receive sufficient analgesic medication after surgery, and more than 44% of children suffered from moderate-to-severe pain after surgery [33, 34]. Therefore, we can reduce the risk of agitation in children through post-operative immediate pain assessment and interventions. Another major predictor of EA under general anesthesia in children with cleft lip and palate was operation duration. The risk of agitation in patients with an operation duration longer than 1 hour was 3.013 times that in children with an operation duration less than or equal to 1 hour. This may be caused by how big the scope of the operation is, the difficulty level of the operation, and the increasing pain level in the postoperative period. Therefore, children with cleft lip and palate who had a longer operating time should be alert to the occurrence of postoperative agitation. In addition, compared with fasting duration ≤ 4 hours, the risk of EA in patients with fasting duration >4 hours was 2.852 times, which was related to starvation-induced agitation. Age was another predictor of EA. The occurrence of EA in children aged over 12 months was 2.932 times higher than that of children aged 3 to 12 months. The results contradicted the previous evidence and need further and deeper investigations. In addition, the predictive model calculated the risk of EA by the scores of the positive factors. All in all, emergence agitation is a post-operative behavioral disturbance observed after anesthesia in children, although EA could be resolved spontaneously, it increased the risk of patient injury, bleeding, parental dissatisfaction with any extra treatments, etc. Therefore, analyze the main influencing factors and intervene, which can effectively help in reducing the occurrence of EA.

The study had some limitations. Firstly, the sample was only from the stomatological hospital, and its representativeness needed further improvements. Secondly, the design considered less interaction between healthcare providers and patients'' anxiety. A study shows that negative interactions and coping were correlated with a higher occurrence of EA [35]. Also, parental anxiety and patients' anxiety may be related to EA[16, 35, 36]. The previous study design did not consider the impact of such factors on EA but only considered the children's demographic variables, surgery, and anesthesia-related variables, etc. Thirdly, some children had a cleft lip and cleft palate at the same time, and it may not be their first-time operation also. Although the operation area was decided for this operation, the influence of previous operations or complications on post-operative emergency agitation could not be excluded. In conclusion, further explorations of research based on the above limitations are expected in future studies.

Author contributions: Yaqin Li, Yongle Shi, Tian Li: experiment designation, data collection, data analysis and manuscript preparation. Xueli Wan: data collection and manuscript writing.

Ethical considerations: The Institutional Ethics Committee approved this project, and the number was WCHSIRB-CT-2020-211-R1.

Funding: The study was funded by the Research and Develop Program at West China Hospital of Stomatology, Sichuan University. Its Grant number was RD-01-202012.

Conflicts of Interest: All the authors declare that they have no conflicts of interest.

Acknowledgment: We want to thank all participants for taking part in this study.

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Table 1 The univariate analysis for emergence agitation in children after general anesthesia(N=190)

Variable	classification	n	Group		X²	P
Variable	classification	n	EA Group (n=132)	Non-EA Group (n=58)	X²	P
Gender	Female	104	69(66.35)	35(33.65)	1.060	0.303
Gender	Male	86	63(73.26)	23(26.74)
Nationality	Han nationality	148	98(66.22)	50(33.78)	3.350	0.067
Nationality	Others	42	34(80.95)	8(19.05)
Weight (kg)	≤10kg	111	67(60.36)	44(39.64)	10.455	0.001
Weight (kg)	＞10kg	79	65(82.28)	14(17.72)
Age (month)	3-12	135	85(62.96)	50(37.04)	9.322	0.002
Age (month)	＞12	55	47(85.45)	8(14.55)
Diagnosis	Cleft lip	78	49(62.82)	29(37.18)	2.762	0.097
Diagnosis	Cleft palate	112	83(74.11)	29(25.89)
Feeding	Breast Feeding	26	14(53.85)	12(46.15)	3.532	0.171
	Artificial Feeding	127	92(72.44)	35(27.56)
	Mixed Feeding	37	26(70.27)	11(29.73)
Caregivers	Parents	103	70(67.96)	33(32.04)	0.243	0.622
Caregivers	Others	87	62(71.26)	25(28.74)
Cost Payment	Self-payment	8	6(75.00)	2(25.00)	2.489	0.288
	Partial reimbursement	143	103(72.03)	40(27.97)
	Full reimbursement	39	23(58.97)	16(41.03)
Fasting duration(h)	≤4	92	53(57.61)	39(42.39)	11.840	0.001
Fasting duration(h)	＞4	98	79(80.61)	19(19.39)
Operation sequence	1	160	109(68.13)	51(31.82)	0.869	0.351
Operation sequence	≥2	30	23(76.67)	7(23.33)
Operative duration (h)	≤1	63	36(57.14)	27(42.86)	6.757	0.009
Operative duration (h)	＞1	127	96(75.59)	31(24.41)
Anesthesia duration (h)	≤1	20	8(40.00)	12(60.00)	9.156	0.002
Anesthesia duration (h)	＞1	170	124(72.94)	46(27.06)
Usage of propofol	Used	173	121(69.94)	52(30.06)	0.200	0.655
Usage of propofol	Unused	17	11(64.71)	6(35.29)
Usage of dressings	Used	64	45(70.31)	19(29.69)	0.032	0.858
Usage of dressings	Unused	126	87(69.05)	39(30.95)
Usage of iodoform	Used	40	35(87.50)	5(12.50)	7.763	0.005
Usage of iodoform	Unused	150	97(64.67)	53(35.33)
Pain Scores (point)	≤3	87	44(50.57)	43(49.43)	27.028	0.000
Pain Scores (point)	＞3	103	88(85.44)	15(14.56)

Table 2 The binary logistic regression analysis for emergence agitation in children after general anesthesia

	Variable	B	S.E.	Wald	df	Sig.	Exp(B)	95% C.I. for EXP(B)
	Variable	B	S.E.	Wald	df	Sig.	Exp(B)	Lower	Upper
Step1^a	Weight (1)	0.099	0.486	0.042	1	0.838	1.104	0.426	2.863
	Age (1)	1.076	0.509	4.461	1	0.035	2.932	1.081	7.955
	Fasting duration (1)	1.048	0.399	6.911	1	0.009	2.852	1.306	6.230
	Operative duration(1)	1.103	0.424	6.772	1	0.009	3.013	1.313	6.913
	Anesthesia duration(1)	0.969	0.589	2.709	1	0.100	2.635	0.831	8.356
	Usage of iodoform (1)	0.864	0.633	1.865	1	0.172	2.373	0.687	8.202
	Pain Scores (1)	2.167	0.436	24.739	1	0.000	8.735	3.719	20.521
	Constant	-2.630	0.679	14.994	1	0.000	0.072

A: weigh age, fasting duration, operative duration, anesthesia duration, iodoform, and pain scores.

R²=0.409, X²=12.502, P＜0.000.

Table3 The brief table of Logistic Regression result

Variable	Group	OR（95%CI）	P
Age(month)	3-12	1
	＞12	2.932(1.081, 7.955)	0.035
Fasting duration(h)	≤4	1
	＞4	2.852(1.306, 6.230)	0.009
Operative duration(h)	≤1	1
	＞1	3.013(1.313, 6.913)	0.009
Pain Scores	≤3	1
	＞3	8.735(3.719, 20.521)	0.000

R2=0.409, X2=12.502, P＜0.000.

No competing interests reported.

A logistic model to predict the rates of emergence agitation in pediatric patients after a cleft lip or palate surgery: a prospective study

Status:

Version 1

Abstract

Objectives:

Materials and Methods:

Results:

Conclusions:

Clinical Relevance:

Figures

Introduction

Material And Methods

Study design and patient selection

Study Setting

Statistical Analysis

Results

Discussions

Declarations

References

Tables

Additional Declarations

Status:

Version 1