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Table 14.4 Sedatives and Analgesics for the Acute Management of Pediatric TBI

Author Year Country

Study Design

Sample Size

Methods Outcome

Shein et al. (2016)

USA

Pre-post

N=16

Population: TBI; Mean Age=3.7yr; Gender: Male=12. Female=4; Mean GCS=5.

Intervention: Patients who received doses of fentanyl, 3% hypertonic saline (HTS), and pentobarbital following intracranial hypertension episodes were analyzed. Mean bolus doses for each pharmacological treatment were: Fentanyl 2 μg/kg, HTS 3 mL/kg, and Pentobarbital 5 mg/kg. The patients received a median of 12 doses. Assessments were conducted at baseline and then monitored every 5 min up to 120 min post-treatment.

Outcome Measure: Intracranial Pressure (ICP) levels, Cerebral Perfusion Pressure (CPP).

1.        ICP levels were significantly decreased after administration of fentanyl, pentobarbital, or HTS within 15–25 min of initiation of the bolus (all p<0.050).

2.        HTS was associated with a significant improvement in ICP within 5 min of initiation (mean change=-2.49 mmHg; p=0.004).

3.        Both HTS and pentobarbital administration independently reduced ICP levels significantly after 5min (both p<0.001).

4.        CPP levels improved after HTS administration (p=0.001) but deteriorated after fentanyl treatment (p<0.001).

5.        An adjusted model for ICP crisis resolution time revealed that HTS was found to be two-times faster than both pentobarbital and fentanyl (p=0.031) in reducing ICP.

Welch et al. (2016)

USA

Case Series

N=31

Population: TBI; Mean Age=8yr; Gender: Male=20, Female=11; Mean GCS=5.

Intervention: Data was collected from medical records of patients admitted to a children’s Level 1 trauma hospital. All patients were intubated, mechanically ventilated, and received bolus doses of fentanyl and/or midazolam for treatment of intracranial hypertension.

Outcome Measure: Intracranial Pressure (ICP) levels, Cerebral Perfusion Pressure (CPP).

1.        There was a significant increase in mean area under the curve (AUC) for ICP (corresponding to an increase in ICP) following high-dose fentanyl (p=0.020), low-dose midazolam (p=0.006), high-dose fentanyl + low-dose midazolam (p=0.007).

2.        AUC-ICP also increased for all other drug/dose combinations (ie. Low-dose fentanyl + high-dose midazolam) but these did not reach statistical significance.

3.        There was no significant change in AUC-CPP after administration of fentanyl and/or midazolam.

Mellion et al. (2013)

USA

Case Series

N=36

Population: TBI; Controlled Refractory

Intracranial Hypertension Group (RICH; n=10): Mean Age=10.7yr; Gender: Male=2, Female=8; Mean Time Post Injury=3.0 hr. Uncontrolled Refractory Intracranial Hypertension Group (URICH; n=26): Mean Age=6.4yr; Gender: Male=13, Female=13; Mean Time Post Injury=1.5 hr.

Intervention: Data on patients admitted between January 2001 and December 2010 and treated with barbiturate infusions for a minimum of 6 hr were extracted from electronic and paper medical records from a hospital trauma database. Patients who experienced Intracranial pressure (ICP) >20 mmHg despite first-tier therapies but treated successfully with barbiturates were classified as RICH and patients who still demonstrated ICP of >20 mmHg despite a minimum of 6 hr barbiturate therapy were classified as URICH. Assessments were conducted at discharge and 3 mo follow-up.

Outcome Measure: ICP levels, Pediatric Cerebral Performance Category (PCPC).

1.        Patients in the RICH group demonstrated significantly lower ICP levels immediately prior to loading dose of barbiturates compared to the URICH group (17 mmHg versus 25 mmHg, p=0.028).

2.        PCPC scores at discharge and at 3 mo follow-up were significantly lower for the RICH group compared to the URICH group (p<0.050).

3.        The amount of change in PCPC score from discharge to 3 mo follow-up did not differ significantly between groups.

4.        The duration of barbiturate infusion was lower for the RICH group compared to the URICH group (median 56 hr versus 90 hr) but this did not reach statistical significance (p=0.433).

5.        The RICH group received barbiturate therapy after a significantly greater amount of time had elapsed compared to the URICH group (median 76 hr versus 29hr, p=0.028).