Purpose <p>Congenital heart disease (CHD) affects 9.3 per 1000 live births in Asia, with 25% being cyanotic. Advanced imaging such as CT angiography is essential, but requires effective sedation in this high-risk group. While parental presence is known to reduce anxiety during mask induction in operating rooms, its effect on intravenous sedation in non-operating room anesthesia (NORA) settings, particularly for diagnostic imaging, has not been studied. This trial evaluates the effect of parental presence during intravenous procedural sedation on ketamine requirements for children with cyanotic CHD undergoing CT angiography in a NORA environment.</p> Methods <p>This prospective, randomized trial included 60 children aged 6 months to 3 years with cyanotic CHD. Participants were randomized to receive sedation either on their mother’s lap (<i>n</i> = 30) or on the CT table (<i>n</i> = 30). The primary outcome was ketamine dose required for a pediatric sedation state scale of 2. Secondary outcomes included preoperative anxiety scores, episodes of oxygen desaturation, time to achieve sedation, and recovery time.</p> Results <p>Children sedated on their mother’s lap required significantly lower ketamine doses compared to those on the CT table (−&#xa0;0.15 mg/kg, 95% CI −&#xa0;0.29 to −&#xa0;0.01; <i>p</i> = 0.03). The mother’s lap group also had lower preoperative anxiety scores and shorter recovery times (−&#xa0;3 min, 95% CI −&#xa0;4.08 to −&#xa0;1.92), with no increase in adverse events.</p> Conclusion <p>This is the first randomized trial to demonstrate that parental presence during intravenous procedural sedation in a NORA setting reduces sedative requirements, anxiety, and recovery times in high-risk children undergoing CT angiography.</p> Clinical trial registration <p>Clinical trial registration: CTRI/2023/11/059539, <a href="https://www.ctri.nic.in/">https://www.ctri.nic.in/</a></p>

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Effect of parental presence on intravenous sedation in children with cyanotic heart disease undergoing CT angiography: a prospective randomized trial

  • Ajay Singh,
  • B. Naveen Naik,
  • Shweta Aghi,
  • Sachin Kumar,
  • Venkata Ganesh,
  • Nivedita,
  • Preethy J. Mathew

摘要

Purpose

Congenital heart disease (CHD) affects 9.3 per 1000 live births in Asia, with 25% being cyanotic. Advanced imaging such as CT angiography is essential, but requires effective sedation in this high-risk group. While parental presence is known to reduce anxiety during mask induction in operating rooms, its effect on intravenous sedation in non-operating room anesthesia (NORA) settings, particularly for diagnostic imaging, has not been studied. This trial evaluates the effect of parental presence during intravenous procedural sedation on ketamine requirements for children with cyanotic CHD undergoing CT angiography in a NORA environment.

Methods

This prospective, randomized trial included 60 children aged 6 months to 3 years with cyanotic CHD. Participants were randomized to receive sedation either on their mother’s lap (n = 30) or on the CT table (n = 30). The primary outcome was ketamine dose required for a pediatric sedation state scale of 2. Secondary outcomes included preoperative anxiety scores, episodes of oxygen desaturation, time to achieve sedation, and recovery time.

Results

Children sedated on their mother’s lap required significantly lower ketamine doses compared to those on the CT table (− 0.15 mg/kg, 95% CI − 0.29 to − 0.01; p = 0.03). The mother’s lap group also had lower preoperative anxiety scores and shorter recovery times (− 3 min, 95% CI − 4.08 to − 1.92), with no increase in adverse events.

Conclusion

This is the first randomized trial to demonstrate that parental presence during intravenous procedural sedation in a NORA setting reduces sedative requirements, anxiety, and recovery times in high-risk children undergoing CT angiography.

Clinical trial registration

Clinical trial registration: CTRI/2023/11/059539, https://www.ctri.nic.in/