Pediatric Deep Sedation for Ophthalmology Procedures in an Outpatient Setting, Risk Evaluation.

Background: Pediatric deep sedation (PDS) performed by a dedicated pediatric sedation service has been found to be safe, convenient, and efficient for minor procedures. Major complications such as cardiopulmonary resuscitation, intubation, and death are rare. However, minor complications such as desaturation, apnea, suctioning, or laryngospasm can occur infrequently. To date, little data exist evaluating PDS use for minor ophthalmology procedures. Aims: The aim of this study was to evaluate the incidence of complications for subjects receiving PDS for minor ophthalmology procedures. Setting: Pediatric children's hospital sedation service. Materials and
Methods: This was a review of a prospectively collected database between 2018 and 2020. A hundred and thirty-four subjects aged 0-18 years, who underwent PDS for minor ophthalmology procedures, were compared to 1119 subjects who received PDS for other procedures (e.g., lumbar puncture, bone marrow aspirate/biopsy, and Botox). Statistical Analysis: SAS software, version 9.4, was used to determine variables associated with deep sedation that were predictive of complications. A multiple logistic regression procedure was conducted. Statistical significance was set at the 0.05 level.
Results: Subjects receiving PDS for ophthalmology procedures had a higher rate of minor complications than the control group (n = 18, 13.4%, vs. n = 58, 5.7%; P < 0001). No major complications occurred in any of the studied subjects. The ophthalmology group had a higher rate of bag-mask ventilation, airway positioning, and suctioning. Conclusions: Ophthalmology procedures using PDS have a greater occurrence of minor complications compared to other painful procedures. No major complications were noted in either group, providing evidence that PDS can be performed safely for ophthalmology procedures using the sedation team model. Copyright:

INTRODUCTION

Children who require procedures that may invoke fear, anxiety, and pain often require sedation and analgesia.[123] There are a variety of minor ophthalmology procedures that require sedation, including congenital nasal lacrimal duct obstruction (CNLDO) probing and stenting, examinations under anesthesia (EUA), and chalazion removals. Historically, these procedures are performed in the operating room (OR) under general anesthesia.[4] However, utilizing pediatric deep sedation (PDS) for diagnostic and minor procedures can offset the demand for the OR, allowing it to focus its limited resources on more complex cases.[5] PDS has several operational and practical benefits: appearing less invasive to parents, decreasing the amount of time the patient and family spend at the hospital, and increased flexibility for the proceduralist.[6]

When performed with a dedicated sedation team, PDS has been shown to be safe for a variety of minor procedures.[78910] The occurrence of major complications is low in PDS. However, minor complications such as oxygen desaturation apnea or laryngospasm are common.[1011] In 2009, the Society for Pediatric Sedation published a multicenter study that evaluated the occurrence of complications during PDS that included over 51,000 procedures. Of those procedures, only 44 were ophthalmology procedures.[11] Few studies have evaluated the safety of PDS for ophthalmology procedures when PDS is provided by a dedicated sedation team.

In this study, we aim to compare the incidence of major and minor complications for subjects receiving PDS for minor ophthalmology procedures to other more common and well-studied minor procedures routinely performed under PDS.

MATERIALS AND METHODS

Data

We performed an audit of the sedation team's prospectively collected database at a pediatric hospital. All procedures were performed at our institution between April 2018 and June 2020. De-identified data were obtained on 134 subjects who underwent PDS for minor ophthalmology procedures and compared to 1119 subjects who received PDS for other minor procedures (control group). Our database is designed for quality control of our PDS service operations and includes more than 100 data points in order to help ensure it correctly reflects what occurred in each case.The database is maintained daily after each sedation, this assures the accuracy of the data. Missing data was limited to subjects’ demographic data, and none were related to missing complications information.

All subjects underwent deep sedation using a combination of propofol as the primary anesthetic and fentanyl or ketamine in adjunct analgesics as needed. The following demographic information was collected: age, gender, race, weight, and body mass index; allergies; and the American Society of Anesthesiologists (ASA) physical status classification. The type of procedure, length of procedure, medications and doses used, and complications that occurred were also obtained from the database.

Inclusion criteria consisted of subjects who underwent ophthalmology procedures or other minor invasive nonophthalmology procedures, received propofol as the primary sedative medication, had an ASA physical status classes I, II, and III, of age 0–18 years, and received PDS by our dedicated sedation team. Exclusion criteria were as follows: subjects who were sedated for noninvasive procedures such as diagnostic imaging procedures and subjects with incomplete information in the database.

Procedures performed

Ophthalmology procedures performed under PDS were eye EUA, probe and stent of nasolacrimal duct (CNLDO), chalazion removal, papilloma removal, foreign body removal, skin tag, laceration repair, mass removal, suture removal, and electroretinogram. Nonophthalmology procedures included in the control group were lumbar punctures, bone marrow aspiration, bone marrow biopsy, Botox injection, electroencephalogram, abscess incision and drainage, and orthopedic procedures. Diagnostic imaging procedures such as magnetic resonance imaging or computed tomography were not included in the control group due to the lack of painful stimulation.

Major and minor complications recorded

Data on both minor complications and major complications were collected. Minor complications were defined as suctioning, airway repositioning, vomiting, hypoxia not requiring intervention, hypoxia requiring intervention, bag-mask ventilation, apnea, oral/nasal airway placement, hypotension requiring intervention, laryngospasm, arrhythmia, and allergic reaction. Major complications were defined as death, cardiopulmonary resuscitation, endotracheal tube, or laryngeal mask placement, or an unplanned admission. This categorization of complications was determined based on the classification system defined in other recent studies from the Pediatric Sedation Research Consortium (PSRC).[12131415]

Procedural protocol

Subjects were screened in advance by a sedation team registered nurse (RN) and assessed the day of the procedure to ensure they were eligible for PDS. Ophthalmology procedures were performed in a dedicated outpatient sedation suite, whereas nonophthalmology procedures were performed either in the sedation suite or other PDS locations throughout the hospital. Topical analgesic cream was offered to all subjects, and intranasal midazolam was given as needed for anxiolysis as a premedication before obtaining intravenous (i.v.) access. i.v. access was then obtained. Cases were performed under a sedation team model with a critical care (CC) or emergency medicine physician. At least one sedation team RN monitored cardiorespiratory status (heart rate and respiratory rate), pulse oximetry, blood pressure, and end-tidal carbon dioxide via capnography throughout the procedure and during recovery. A separate provider was responsible for performing the procedure for all subjects.

Ethical considerations

As this is a retrospective review from a quality improvement database, the only risk to subjects was a breach of confidentiality. However, all data used in the study were de-identified of all personal identifiable information. An exemption from the University of Arkansas for Medical Sciences Institutional Review Board (number 260620, October 01, 2020) and due to the nature of the review and waiver of consent was granted by the same IRB.

RESULTS

During the study period, 2189 subjects received sedation. A total of 134 ophthalmology and 1119 nonophthalmology procedures (control group) were included for the final analysis, based on the specified inclusion and exclusion criteria [Figure 1]. Four subjects were excluded due to missing demographic data. Demographic data are presented by the study group in Table 1. The distribution of age differed significantly between the groups. The ophthalmology group was younger compared to the control group. In addition, the distribution of ASA PS class differed significantly between the groups, with the ophthalmology group having a greater percentage of ASA PS class I cases (76.1%) compared to the control group that had a greater percentage of ASA PS class II cases (90.6%).

Figure 1

Subject inclusion and exclusion tree

Table 1

Demographics

	Ophthalmology group (n=134)	Control group (n=1119)	P
Gender
Male	73 (54.5)	587 (52.5)	0.231
Female	61 (45.5)	528 (47.2)
Transgender	0	4 (0.3)
Race
White	81 (60.4)	651 (58.2)	0.686
African American	28 (20.9)	207 (18.5)
American Indian or Alaska Native	20 (14.9)	225 (20.1)
Asian	1 (0.7)	6 (0.5)
Unknown	4 (3)	30 (2.6)
ASA
I	102 (76.1)	39 (3.5)	<0.001
II	31 (23.1)	1014 (90.6)
III	1 (0.8)	66 (5.9)
Age (years)
<1	8 (6)	7 (0.6)	<0.001
1-4	71 (53)	274 (24.5)
5-11	39 (29.1)	479 (42.8)
12+	16 (11.9)	359 (32.1)

ASA=American Society of Anesthesiologists

Procedures performed during the study period for the ophthalmology group were as follows: lacrimal duct stenosis stenting (CNLDO; n = 51, 38.1%), chalazion removal (n = 38, 28.4%), EUA (n = 31, 21%), papilloma excision (n = 2, 1.5%), foreign body removal (n = 2, 1.5%), laceration repair (n = 2, 1.5%), and others (n = 8, 6%). While the majority of subjects sedated for ophthalmology procedures received a combination of propofol and fentanyl (n = 64, 47.8%), the control group had a statistically significant higher rate of use of this combination (n = 874, 78%; P < 0.001). The use of ketamine in sedation combinations was significantly more common in the ophthalmology group [Table 2].

Table 2

Medications used for sedation

Medication	Ophthalmology, n (%)	Control group, n (%)	P
Propofol	33 (24.6)	203 (18.1)	0.07
Propofol and fentanyl	64 (47.8)	874 (78)	<0.001
Propofol ketamine	32 (23.9)	41 (3.7)	<0.001
Propofol, ketamine, and fentanyl	5 (3.7)	1 (0.9)	<0.001

Subjects receiving sedation for ophthalmology procedures had a statistically significant greater percentage of minor complications than the control group (n = 18, 13.4%, vs. n = 58, 5.7%, respectively; P < 0.001) [Table 3]. No major complications occurred in any of the studied subjects. The ophthalmology group had a statistically significant greater need for bag-mask ventilation, airway positioning, and suctioning [Table 3].

Table 3

Sedation complication events

Complications	Ophthalmology (n=134), n (%)	Control group (n=1119), n (%)	P
Major complications	0	0
LMA	0	0
ETT	0	0
Unplanned admission	0	0
Cardiac arrest	0	0
Death	0	0
Minor complications	18 (13.4)	58 (5.7)	<0.001
Apnea	9 (6.7)	22 (2)	0.004
Hypoxia requiring intervention	12 (9)	33 (2.9)	0.002
Hypoxia not requiring intervention	1 (0.7)	3 (0.2)	0.364
BMV	12 (9)	36 (3.2)	0.001
Oral/nasal airway	2 (1.5)	0	0.011
Airway reposition needed	17 (12.7)	30 (2.6)	<0.001
Suction needed	12 (9)	8 (0.7)	<0.001
Hypotension requiring intervention	0 (0)	2 (0.1)	0.624
Vomiting	2 (1.5)	0	0.011
Arrhythmia	1 (0.7)	0	0.107
Allergic reaction	1 (0.7)	1 (0.1)	0.203

LMA=Laryngeal mask, ETT=Endotracheal tube, BMV=Bag-mask ventilation

DISCUSSION

The primary objective of this audit of PDS was to compare the occurrence of complications in subjects receiving PDS for minor ophthalmology procedures to the complication rate of other painful procedures performed under PDS. We found that subjects receiving PDS for ophthalmology procedures more commonly experienced minor complications than those in the control group of other painful procedures. However, no major complications occurred in either cohort.

While the utilization of PDS has increased in recent years, not many studies have been published describing the use of PDS for ophthalmology procedures.[5716] In a multicenter PSRC study that examined more than 51,000 procedures performed over 4 years involving deep sedation/anesthesia outside of the OR, only 44 ophthalmology procedures were reported.[11] Multiple studies have shown a low incidence of both serious and minor complications when PDS is used for a variety of procedures.[111517] In addition, research has also consistently shown that PDS can be provided safely by PDS providers outside of the OR.[81418]

Two other retrospective chart reviews have examined the use PDS for ophthalmology procedures.[46] Movaghar et al. reviewed the procedure time and cost for 22 patients undergoing CNLDO probing. They found a decrease in the amount of time of the procedure and that costs were reduced by a third compared to performing the same procedure in the OR.

To date, the most comprehensive study was performed by Lalwani et al. and evaluated the safety and cost of 855 ophthalmology procedures performed under PDS.[6] Although a sedation service model was utilized in this study, all sedations were performed by an anesthesiologist. The most common complications reported in the study were as follows: transient oxygen desaturation (8.6%), airway obstruction (3.6%), and apnea (0.6%). In our study, we found similar rates of hypoxia (9%), and higher levels of airway positioning (12.7%), and apnea (6.7%) [Table 3]. Neither Movaghar nor Lalwani evaluated the safety of CC or ED providers for PDS, nor did they compare the occurrence of complications to other routine PDS procedures. To our knowledge, our study is the largest study that evaluated the use of PDS for ophthalmology procedures outside of the OR and performed by pediatric CC sedation physicians.

Despite there being more minor complications in the ophthalmology group when compared to the control group of other painful procedures, no major complications were documented. These minor complications were managed effectively by the sedation team physicians. Although there was a minor complication increase, overall ophthalmology procedures were found to be safe if performed by a dedicated sedation team outside of the OR.

Waiting lists for anesthesia and OR availability can lead to long wait times for outpatient procedures. The use of a PDS service for ophthalmology procedures at our institution has been used to decrease the amount of time patients have to wait for an appointment that would have been previously scheduled in the OR. The PDS service has also allowed our institution to allocate expert anesthesia resources to more complex cases that require the use of an OR. While we did not evaluate the cost savings released by moving those procedures out of the OR, it can be expected that the cost of procedures would be lower as shown by Movaghar et al.[4] In addition, the setting of procedures performed by a sedation team can be more family centered, yielding high patient satisfaction scores when feedback is requested.[1019] In our setting, the families can accompany the child to the procedure room and at times remain present for the entire procedure. Utilizing one room for presedation screening, procedure performance, and recovery, with the presence of one dedicated nurse for all those stages, may decrease the emotional stress on children and improve patient satisfaction. This makes this model appealing to parents and ophthalmology physicians.

Overall, the experience of the ophthalmologists was very positive in our practice. They indicated that from their perspective, it is also advantageous to perform those procedures in a designated sedation area outside of the OR because of easier access and scheduling, and faster turnover times.

Limitations

There were several limitations to our study. This is a database audit, performed at a single center. Although ASA is documented, the dataset lacks presedation information to identify the degree of preexisting conditions that may put patients at risk for complications. Although the sample size is one of the highest for similar studies, it still can be considered limited. Due to the nature of the database, it was not possible to evaluate the financial impact of performing those procedures out of the OR.

CONCLUSIONS

In this study, we found that ophthalmology procedures using PDS had a higher rate of minor complications compared to a control group of other minor procedures performed outside of the OR by PDS providers. However, no major complications were recorded in either group. PDS can be performed safely for ophthalmology procedures using the sedation team model, consisting of trained sedation physicians and nurses. This is a new frontier for PDS and offers opportunities for pediatric patients to get ophthalmology procedures performed more readily and allow anesthesiology staff to prioritize more complicated procedures to be performed in the OR.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.