Oral Ketorolac (Toradol) for Back Pain
Oral ketorolac should NOT be prescribed as initial therapy for back pain—it is FDA-approved only as continuation therapy following IV or IM ketorolac administration, with a strict maximum combined treatment duration of 5 days. 1
FDA-Approved Dosing for Oral Ketorolac
Oral ketorolac is explicitly contraindicated as a first-line or standalone treatment. 1 The FDA labeling specifies:
- Patients age 17-64 years: 20 mg PO once (as first oral dose after IV/IM therapy), then 10 mg every 4-6 hours as needed, maximum 40 mg/day 1
- Patients ≥65 years, renally impaired, or weight <50 kg: 10 mg PO once, then 10 mg every 4-6 hours as needed, maximum 40 mg/day 1
- Total duration (IV/IM + oral combined): Must not exceed 5 days 1
Why Oral Ketorolac Is Not Appropriate for Outpatient Back Pain
The FDA restriction exists because oral ketorolac has limited utility for acute moderate-to-severe pain due to:
- Prolonged onset to analgesic action (30-60 minutes) 2
- More than 25% of patients exhibit little or no response 2
- Maximal effect occurs approximately 2.2 hours after dosing 3, 4
Recommended Alternative: Standard Oral NSAIDs
For outpatient back pain management, prescribe standard oral NSAIDs (ibuprofen, naproxen, or meloxicam) instead of ketorolac. 5, 6, 3
First-Line NSAID Options:
- Ibuprofen: 400-800 mg every 6 hours, maximum 2.4 g/day 3
- Naproxen: 500 mg twice daily 5
- Meloxicam: 7.5 mg once daily, may increase to 15 mg once daily 6
Pre-Prescription Risk Assessment:
- Assess cardiovascular risk factors (NSAIDs increase MI/stroke risk) 6, 7
- Assess gastrointestinal risk factors (NSAIDs increase bleeding/ulcer risk) 6, 7
- Assess renal function (avoid in significant renal impairment) 3
- Consider proton-pump inhibitor co-administration in high-risk patients 6, 7
Alternative First-Line Option for High-Risk Patients
For patients with cardiovascular risk factors, prescribe acetaminophen instead of NSAIDs: 7
- Dosing: 1000 mg every 6 hours (maximum 4 g/day) 7
- Acetaminophen has slightly weaker analgesic effect than NSAIDs but superior safety profile 7
Second-Line: Add Muscle Relaxant if Inadequate Response
If NSAIDs alone provide inadequate relief after 3-7 days, add a muscle relaxant for short-term use (≤2 weeks): 5, 7, 3
- Cyclobenzaprine: Most commonly studied, moderate evidence for efficacy 5
- Methocarbamol or tizanidine: Alternative options 5
- Warning: All muscle relaxants cause sedation and CNS adverse effects 5, 7
Third-Line: Consider Gabapentin for Radicular Pain
If radicular symptoms (sciatica/leg pain) are present, add gabapentin: 5, 3
- Starting dose: 100-300 mg at bedtime 5
- Titration: Increase by 100-300 mg every 1-7 days as tolerated 5
- Target dose: 1200-3600 mg/day in 3 divided doses 5, 3
- Gabapentin shows small, short-term benefits specifically for radiculopathy 5
Fourth-Line: Opioids (Use Sparingly)
Reserve opioids only for severe, disabling pain uncontrolled by NSAIDs and muscle relaxants: 7, 3
- Tramadol: 50 mg every 4-6 hours (preferred due to lower abuse potential) 5, 7
- Short-acting opioids: Hydrocodone 5-15 mg or oxycodone 5-15 mg every 4-6 hours 7
- Limit duration to ≤1 week to minimize risk of dependence 7
Critical Contraindications to Ketorolac
Never prescribe ketorolac (oral or parenteral) in patients with: 3
- Aspirin/NSAID-induced asthma
- Pregnancy
- Cerebrovascular hemorrhage
- Significant renal impairment
- Age >60 years (relative contraindication—use lower doses and shorter duration) 3