Phase 4 N=109 Randomized Treatment

Pregabalin vs. Gabapentin on Reducing Opioid Usage

Analgesics · Gabapentin · Injuries · Narcotics · Pain

Bottom Line

View on ClinicalTrials.gov: NCT04705480 ↗

Enrolled (actual)

109

Serious AEs

6.9%

Results posted

Jan 2026

Primary outcome: Primary: Reduction in Opioid Usage — 69.5; 81; 66.3 MME — p=0.687

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Pregabalin 50mg (Drug); Gabapentin 300mg (Drug); Neither Pregabalin nor Gabapentin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: CAMC Health System
Primary completion: Sep 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Reduction in Opioid Usage	69.5; 81; 66.3	0.687
SECONDARY Difference in Initial and Last Incentive Spirometry Values	400; 0; 250	0.346
SECONDARY Rate of Intubation	0; 2; 0	<0.05 sig
SECONDARY Pain Control	6.4; 6.2; 6.2	<0.05 sig
SECONDARY Hospital Length of Stay	3.0; 4.0; 4.3	<0.05 sig
SECONDARY Rate of Unplanned ICU Admission	0; 2; 0	<0.05 sig

Summary

This is a single-center, randomized, open-label, Phase 4 clinical trial investigating the efficacy of multiple-dose administrations of Pregabalin or Gabapentin in combination with traditional opioid pain medications to decrease the amount of opioid pain medication usage in single-system orthopedic trauma patients.

Eligibility Criteria

Inclusion Criteria

Nurse Practitioner service admissions
18 years of age or older
Patients enrolled within 36 hours of admission
Anticipated duration of hospitalization > 24 hours from time of consent
Active order(s) for opioids in place at the time of enrollment

Exclusion Criteria

Clinician discretion based on patient care management
Intubated patients
Patients with epidural
Patients with pregabalin/gabapentin as home medications
Patients receiving pregabalin/gabapentin upon admission
Traumatic brain injury patients
CrCl<30ml/min or on HD
Unable to take enteral medications
On Patient Controlled Analgesia (PCA)
Patients with complicated wound closure
History of epilepsy
Documented history of substance use disorder

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04705480). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.