A randomized controlled trial comparing a fascia iliaca compartment nerve block to a traditional systemic analgesic for femur fractures in a pediatric emergency department.

STUDY
OBJECTIVE: We determine whether a fascia iliaca compartment nerve block can provide superior pain management compared with intravenous morphine sulfate for the initial pain management of femur fracture patients presenting to a pediatric emergency department. The primary outcome measured is pain scores; a difference of 15% in scores assessed at 30 minutes from the study's baseline pain management is considered clinically meaningful. Secondary outcomes include the duration of analgesia, the need for additional medications, adverse events, nerve block complications, and satisfaction scores.
METHODS: This was a prospective, randomized, unblinded, controlled trial conducted on children aged 15 months to 18 years with acute femur fractures, presenting to a free-standing, tertiary care children's hospital. Patients were randomized to receive intravenous morphine sulfate or a fascia iliaca compartment nerve block using ropivacaine (Naropin). Pain scores (Children's Hospital of Eastern Ontario Pain Scale [CHEOPS]; Face, Legs, Activity, Cry and Consolability Pain Scale; Faces Pain Scale) were recorded at initial analgesic administration (baseline), at 5, 10, 15, 30, and 60 minutes, and then hourly up to 6 hours from baseline by trained nursing observers and research assistants.
RESULTS: Fifty-five patients, 26 in the fascia iliaca compartment nerve block group and 29 in the morphine sulfate group, ranged in age from 16 months to 15 years (median 5.7 years). Baseline mean CHEOPS scores were similar: 9.4 fascia iliaca compartment nerve block and 9.5 morphine sulfate. Mean CHEOPS scores at 30 minutes after initial treatment were 5.87 for fascia iliaca compartment nerve block and 7.54 for morphine sulfate, with a difference of 1.67, which corresponds to an 18% (95% confidence interval [CI] 8% to 27%) difference in pain reduction between the 2 groups, according to the average baseline score of 9.45. Similar lower pain scores were observed in the fascia iliaca compartment nerve block group as early as 10 minutes from baseline and throughout the 6-hour duration of the study. In comparing the entire 6-hour CHEOPS pain scores, patients who received a fascia iliaca compartment nerve block showed lower scores by approximately 15% (95% CI 6% to 24%) compared to patients who received morphine sulfate. Median duration of analgesia was longer in the fascia iliaca compartment nerve block group compared with that in the morphine sulfate group (313 minutes [95% CI 154 to 360 minutes] versus 60 minutes [95% CI 10 to 255 minutes]). Fewer additional medications were given to patients who received the fascia iliaca compartment nerve block. No complications from the nerve block occurred. Satisfaction scores were higher with the fascia iliaca compartment nerve block among the medical staff.
CONCLUSION: Fascia iliaca compartment nerve block provided clinically superior pain management compared with intravenous morphine sulfate at 30 minutes from baseline and throughout the initial 6 hours of medical treatment of children 16 months to 15 years who had isolated acute femur fractures. The results of this study, however, may be inflated by the nonblinding of the pain observers. Despite this potential bias, the fascia iliaca compartment nerve block should be considered as a valuable procedure in managing the pain commonly observed in these injured children.

RCT Entities:   Population Interventions Outcomes