Children with ASD respond well to a family-centered procedural sedation protocol

Children with ASD respond well to a family-centered procedural sedation protocol | Image Credit: © Khunatorn - © Khunatorn - stock.adobe.com.

In a recent study, 93% of patients with autism spectrum disorder (ASD) or with developmental delay (DD) did not require physical restraint for common medical procedures when utilizing a family-centered procedural sedation protocol, according to Jama Network Open.

For patients with ASD or DD, completing routine health care (physical examinations, blood sampling, vaccinations, or dental care) is difficult and can often be traumatic, which can lead to physical restraint or the postponement of the procedure or examination, according to the study authors. “Pharmacologic treatment with oral sedatives may be insufficient to perform common minor procedures, while the intramuscular route, requiring physical restraint for administration, can deepen the fear and lack of trust these children have toward the health care system,” the authors wrote.

The “consecutive case series using a family-centered integrated behavioral and sedation protocol for common medical procedures in these children,” was approved by the Swiss Association of Ethics Committees. Investigators created a procedural sedation protocol for children aged 2 to 16 years with ASD or DD, defined by parents as “previously unapproachable for routine immunizations and venipuncture because of extreme agitation.” Children were enrolled with informed consent from parents or legal guardians and after discussions with parents and the patient’s referring pediatrician or pediatric subspecialist took place. Investigators hypothesized that an “integrated behavioral-pharmacologic protocol is safe and effective” for this population. The need for physical restraint was the main outcome measure of the study.

Home desensitization to intranasal drug delivery, environmental modification, and intranasal dexmedetomidine, combined with nitrous oxide (N₂O), was used in the study. The combination of dexmedetomidine and N₂O was used since “dexmedetomidine alone would not allow painful procedures to be performed comfortably,” according to the authors. The patient, procedure, and sedation information were collected with each sedation, while study data were collected from June 2021 to December 2022. Data analysis was conducted from January to February 2023.

Forty-four children and their parents were approached for enrollment, and 43 participated. The median (interquartile [IQR]) age of the patients was 7.2 (4.5-11.4) years. Thirty-one (72%) of the patients were male. In all, 39 out of the 42 patients (93%) who underwent the planned procedure did so without physical restraint, the primary outcome measure. Three patients needed brief (less than 30 seconds) restraint, as 1 patient was restrained by 1 person, and 2 patients were restrained by 2 persons. The procedure was aborted in 1 patient because the sedation was “suboptimal.”

Of the patients, 29 (67%) were diagnosed (patients could have 1 or more diagnoses) with ASD, 10 (23%) with developmental delay not otherwise specified (NOS), 7 (16%) with epilepsy with associated developmental delay, and 4 (10%) with behavioral disorder NOS. Fourteen (33%) of patients were receiving a psychotropic medication such as aripiprazole, risperidone, or an amphetamine. For types of procedure, 38 (88%) patients had blood drawn, 22 (51%) had an electrocardiogram, 5 (12%) patients had a dental examination, 3 (7%) had abdominal or cardiac ultrasonographic imaging, 2 (5%) had a lumbar puncture, 2 (5%) had a nasofibroscopy, 2 patients (5%) received an auditory evoked potentials test, 2 patients (5%) had a suture removal procedure, 1 patient (2%) had a balloon gastrostomy button replacement, and 1 patient (2%) had a optic nerve examination.

No intermediate or sentinel adverse events were reported during sedation or at the 24-hour follow-up call. Overall, procedures were completed successfully in 98% of patients, and the drug regimen was “perceived as well tolerated, safe, and effective.” For nonpainful procedures, intranasal dexmedetomidine has been used safely and effectively in children with ASD, though it can be perceived as invasive or frightening. As in the study protocol, previous home desensitization to intranasal drug administration can lead to greater acceptance when performed in a safe, familiar environment and by a parent. Though the main limitation of the study was the lack of a control group with differing behavioral and pharmacologic approaches, the study represents “proof of concept of the safety and efficacy of an integrated behavioral and pharmacologic approach of home desensitization, environmental modification, and an intranasal and inhalational pharmacologic regimen,” the authors concluded. They note future studies are needed to compare this approach with other techniques.

Reference:

Sahyoun C, Krauss B, Bevacqua M, Antonsen A, Jardinier L, Barbi E. Safety and efficacy associated with a family-centered procedural sedation protocol for children with autism spectrum disorder or developmental delay. JAMA Netw Open. 2023;6(5):e2315974. doi:10.1001/jamanetworkopen.2023.15974