What is the best sedation medication for pediatric patients undergoing procedure sedation in the Emergency Department (ED)?

Best Drug for Procedural Sedation in Pediatric ED Patients

Ketamine combined with midazolam is the best first-line choice for most pediatric procedural sedation in the ED, offering superior efficacy with fewer respiratory complications compared to fentanyl/midazolam, while propofol remains an excellent alternative when rapid recovery is prioritized and appropriate monitoring is available. 1

Primary Recommendation: Ketamine/Midazolam Combination

For painful orthopedic procedures and most ED interventions, ketamine/midazolam demonstrates Level I evidence superiority over fentanyl/midazolam. 1 In a well-designed randomized controlled trial of 260 pediatric patients (ages 5-15 years), ketamine/midazolam showed:

• Significantly less hypoxia: 6% vs 25% 1
• Fewer airway interventions: breathing cues needed in 1% vs 12%, oxygen required in 10% vs 20% 1
• Better efficacy: lower distress scores and increased physician satisfaction 1
• Faster procedures and shorter recovery times 1

Dosing Protocol for Ketamine/Midazolam

• Ketamine: 0.5 mg/kg IV every 3 minutes (up to 2 mg/kg total) 1
• Midazolam: 0.1 mg/kg IV (maximum 2.5 mg) 1
• Add glycopyrrolate 5 mcg/kg (up to 250 mcg) to reduce secretions 1
• For IM administration: ketamine 3.30±0.80 mg/kg with midazolam 1

Safety Profile

Ketamine/midazolam is remarkably safe across large pediatric populations. 1 In a prospective case series of 1,180 pediatric patients, the adverse event rate was only 1.8% (1 laryngospasm, 2 desaturations, 1 emesis). 1 The combination provides both analgesia and sedation without depressing airway reflexes, making it advantageous for painful procedures. 2

Common but manageable adverse effects include: 3

• Tachycardia (27.9%)
• Increased secretions (17.6%) - mitigated by glycopyrrolate
• Agitation (13.6%)
• Hallucination (8.7%) - does not require specific treatment
• Recovery agitation occurs in 7% but adding midazolam does not reduce this incidence 2

Alternative Regimen: Propofol (With or Without Fentanyl)

Propofol provides effective sedation with significantly shorter recovery time (14.9 minutes vs 76.4 minutes for midazolam) but requires deeper sedation levels and more intensive monitoring. 2 The American Society of Anesthesiologists provides Level B recommendation for propofol in emergency procedures. 2

When to Choose Propofol

• Rapid recovery is the priority (diagnostic procedures, quick interventions) 4
• Dedicated sedation unit with appropriate monitoring available 1
• Painless procedures (propofol alone is acceptable for non-painful studies like imaging) 4

Propofol Dosing and Safety

• Initial dose: 1 mg/kg IV 1, 2
• Supplemental doses: 0.5 mg/kg as needed 1, 2
• For painful procedures, ALWAYS combine with fentanyl 1-2 mcg/kg - propofol has zero analgesic properties 4

Safety data from large pediatric studies: 1

• 100% procedure success rate across 291 sedations 1
• 93% maintained oxygen saturation >90% 1
• 4% developed partial airway obstruction corrected with jaw thrust 1
• 1% experienced apnea requiring brief bag-mask ventilation 1
• No intubations required 1

In another prospective study of 392 consecutive pediatric patients, oxygen saturation was maintained >90% in 95% of patients, with median hypoxia duration of 1-3 minutes and no intubations required. 1

Third Option: Fentanyl/Midazolam

While historically popular, fentanyl/midazolam is now considered second-line due to higher respiratory depression risk compared to ketamine/midazolam. 1 The American College of Emergency Physicians provides Level B evidence supporting this combination, but with important caveats. 2

Critical Safety Concern

The combination of fentanyl and midazolam markedly increases hypoxia and apnea risk compared to either agent alone. 1 In adult volunteers:

• Midazolam alone: no significant respiratory effects 1
• Fentanyl alone: hypoxemia in 50%, apnea in 0% 1
• Combined: hypoxemia in 92%, apnea in 50% 1

When Fentanyl/Midazolam May Be Appropriate

• Patient has contraindications to ketamine (uncontrolled hypertension, psychosis, increased intracranial pressure) 2
• Procedure requires profound amnesia as primary goal 4

Dosing Protocol

• Administer fentanyl FIRST (it poses greater respiratory depression risk) 2
• Fentanyl: 50-100 mcg IV initially, then 25 mcg every 2-5 minutes 2
• Midazolam: 1-2 mg IV initially, titrated slowly over at least 2 minutes 2, 5
• Allow 2+ minutes between doses to assess effect 5
• Reduce doses by 50% in elderly or high-risk patients 2

Age-Specific Considerations

Younger children require higher doses of ketamine/midazolam (p=0.003 for midazolam, p<0.001 for ketamine). 3 In children receiving midazolam-ketamine sedation:

• 96% achieved adequate sedation within 30 seconds 3
• 75% required only the starting dose 3
• Median recovery time: 87 minutes 3

For oral midazolam premedication (when IV access is difficult or unnecessary):

• Dose: 0.5 mg/kg orally 6
• Onset: 15 minutes 6
• Effective in 76% of children 6
• Amnesia achieved in 66% 6
• Paradoxical hyperagitation in 6% (does not require treatment) 6

Monitoring Requirements (All Regimens)

Continuous monitoring is mandatory regardless of agent chosen: 5

• Pulse oximetry (continuous) 2
• Capnography (strongly recommended for early hypoventilation detection) 2
• Blood pressure and heart rate 2
• Respiratory rate 2

Personnel requirements: 5

• For deeply sedated pediatric patients, a dedicated individual other than the practitioner performing the procedure should monitor the patient throughout 5
• Immediate availability of resuscitative drugs and age-appropriate equipment 5
• Personnel trained in airway management and skilled in establishing pediatric vascular access 5

Common Pitfalls to Avoid

1. Never use propofol alone for painful procedures - it has zero analgesic properties and must be combined with opioids or local anesthesia 4

2. Do not exceed midazolam 0.3 mg/kg without extreme caution - half of children receiving this dose developed desaturation 3

3. Avoid rapid bolusing of midazolam - always administer over at least 2 minutes and allow 2+ minutes to evaluate effect before additional dosing 5

4. Do not underestimate respiratory depression with fentanyl/midazolam - the combination causes more CO2 retention than other commonly used agents (50% had ETCO2 increase >10 mmHg) 1

5. Have reversal agents immediately available - naloxone for opioids, flumazenil for benzodiazepines 2

6. Post-naloxone observation must be minimum 2 hours to ensure resedation does not occur 2