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Naloxone is an opiate-receptor blocker that is thought to improve spinal blood flow in SCI patients (Flamm et al. 1985). Animal models of acute SCI have shown that naloxone effectively reduces ischemia and promotes neurological recovery (Faden et al. 1981a, 1981b; Young et al. 1981). One early phase-one clinical trial deemed naloxone to be safe when administered to patients with acute SCI (Flamm et al. 1985).

Table 3. Naloxone for Neuroprotection in Acute SCI

Author Year

Country

Research Design

PEDro

Sample Size

MethodsOutcomes
Bracken et al. (1990)

USA

RCT

PEDro=10

N=487

Population: Age range=13-34 yr; Gender: not specified; Level of injury: not specified; Severity of injury: complete= 60%, incomplete=40%.

Treatment: Patients were randomized to receive either naloxone (25 mg/mL), methylprednisolone (MP; 62.5 mg/mL) or placebo. Both drugs were administered as a 15 minute loading dose followed by a 23 hr maintenance dose.

Outcome Measures: The following after 6 weeks and 6 months: motor function, sensory function (pinprick and light touch), adverse event outcomes.

Chronicity: Individuals were randomized to study groups within 12 hr of sustaining injury.

Overall Analysis:

1.     There were no significant improvements in motor function or sensory function in patients who received either naloxone or MP compared those who received placebo 6 weeks and 6 months after injury (p>0.05).

2.     There were no significant differences in adverse event outcomes during hospitalization between those who received naloxone, those who received MP, and those who received placebo (p>0.05).

Discussion

The only study since 1990 that has investigated the neuroprotective effectiveness of naloxone in acute SCI was conducted by Bracken et al. (1990). Overall, the authors found no significant differences between individuals who received naloxone and those in the placebo group in terms of motor recovery, sensory recovery and medical complications.

Conclusion

There is level 1b evidence (from one RCT; Bracken et al. 1990) that naloxone is not effective for the promotion of neurological recovery in acute SCI individuals.

Naloxone is not effective for neurological recovery during the acute phase post SCI.