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A family-centered, integrated behavioral and sedation protocol proved successful for common medical procedures among children with autism spectrum disorder (ASD) or developmental delay.

In the case series, the sedation protocol consisted of home desensitization to intranasal drug delivery, environmental modification, and intranasal dexmedetomidine combined with nitrous oxide (N₂O), explained Cyril Sahyoun, MD, of Children's Hospital of Geneva, and colleagues.

Of 44 children and parents approached for study enrollment, 43 consented. Most (88%) were getting a blood draw while 51% were getting an electrocardiogram. Procedures were successfully completed in 42 of the children, and 39 patients had their procedures without physical restraint, they reported in .

In addition, the drug regimen was perceived as well-tolerated, safe, and effective, the researchers wrote.

Three patients required brief restraint of less than 30 seconds (one patient by one person; two patients by two persons), they reported. A procedure was aborted in one patient because sedation was suboptimal.

But there were no intermediate or sentinel adverse events during sedation or at the 24-hour follow-up call, according to the researchers.

"Many advances have been made in the past 20 years to tackle procedural pain and anxiety in children," Sahyoun told MedPage Today in an email. However, populations for which it has been difficult to improve care include children with ASD and developmental delay, he added. "This study shows advances for those patients too."

Sahyoun noted that the children who took part in the protocol showed signs of starting to trust the medical system.

"For example, a teenager who was extremely fearful the first time, walked in on her own the third time, and when she saw the N₂O mask, sat on the hospital bed and spontaneously brought it to her face and started doing breathing exercises," he said. "This was for us a sign that children can progressively 'heal' from a prior traumatic experience even after one or two encounters with such a protocol, and smaller doses of medications could perhaps be used or a lighter sedation could be performed for future procedures."

From June 2021 to December 2022, the researchers enrolled 43 patients (median age 7 years, 72% boys) for the case series after a discussion between the referring pediatrician or subspecialist and parents. The children were described by their parents as previously unapproachable for routine immunization and venipuncture due to extreme agitation.

Two-thirds of the kids had an ASD diagnosis and 19% had an associated genetic or congenital disorder.

The protocol was developed for children ages 2 to 16 years meeting certain cognitive and anesthesiology criteria. A week prior to their child's scheduled procedure, parents were emailed instructions that were followed by a phone conversation with a nurse. Parents then delivered saline into their child's nostrils two to three times per day using a commercial spray, "in a familiar, quiet, and perceived-as-safe environment for the child," the authors stated.

Upon arrival for their scheduled procedures, children were given intranasal dexmedetomidine, which was administered by their parents with direct supervision by clinicians (or by clinicians if parents preferred) through a mucosal atomizer device.

"Although tilting the head back was encouraged during administration, focus was placed on position of comfort, for example in the parent's arms," they wrote. "To augment desensitization, the device was then given to the child to take home."

Furthermore, the procedure rooms were kept as quiet as possible, and the use of devices, such as mobile phones with children's preferred music or video, was encouraged. Patient safety monitoring was started only after drug administration. After dexmedetomidine was given, sleeping conditions were maximized through dimming the lights, communicating by whispering, placing children in their usual sleeping position, and arranging for interpreters if different languages were spoken.

Once children were asleep, parents (supervised by clinicians) applied an unscented face mask delivering a free-flowing mixture of 50% N₂O/50% oxygen.

"The success of the protocol is in its details," Sahyoun added. "Modifying the environment ... seems crucial for a good outcome."

Emily Kuschner, PhD, of Children's Hospital of Philadelphia, told MedPage Today that there is wide variation in how stressful routine medical procedures and vaccinations can be for children with ASD and other development delays, as well as for children who do not have those conditions.

"I think the idea of not assuming a child is unable to do something is really important," said Kuschner, who was not involved in the study.

In particular, she noted the importance of partnering with parents, highlighting components of the protocol such as the provision of instructions to parents in writing and in visual images, and the inclusion of clinical team members who followed up with parents and worked with them throughout the process.

Kuschner also noted that the study described having an ideal plan, but to be prepared to be flexible.

A limitation, according to the researchers, was the lack of a control group with "a different behavioral and pharmacologic approach," and they added that "future studies comparing this approach with other techniques are needed."

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