Comparing Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol Administration for Carpal Tunnel Release and Distal Radius Fracture Surgeries
Phase: PHASE4
Conditions: Postoperative Pain, Carpal Tunnel Release, Distal Radius Fracture
Sponsor: John Fowler

Pain Outcomes of Intra-operative IV Tylenol and/or Toradol for Carpal Tunnel and Distal 
Radius Fracture Surgeries 
NCT 02313675 
Initial IRB approval: 5/11/15 
Most recent IRB renewal: 1/25/17 

This study was designed as a randomized, double-blind, placebo-controlled study. The study was 
approved by our local Institutional Review Board, PRO14110464. It was registered with 
Clinicaltrials.gov, NCT02313675. Patients were recruited from the clinical practice of the senior 
author and enrolled in the study if consented to undergo endoscopic carpal tunnel release. The 
following exclusion criteria were used: current pregnancy, allergy to acetaminophen or 
ketorolac; medical contraindication to acetaminophen and/or ketorolac; pre-operative/current use 
of opioids; history of IV drug abuse; workers’ compensation. 
The Investigational Drug Service (IDS) at our institution randomized subjects using a blocked 
computerized randomization protocol and dispensed the study medication. The four treatment 
arms include: placebo (Group 1), IV acetaminophen (Group 2), IV ketorolac (Group 3), or both 
IV acetaminophen and IV ketorolac (Group 4). The dose of ketorolac was 10 mg and the dose of 
acetaminophen was 1000 mg. Subjects and surgeon were blinded to the medication given as IDS 
will dispensed the medications in opaque syringes. The medications were given 5 minutes prior 
to skin incision. 
All patients undergoing carpal tunnel release were treated according to the same standard 
protocol for anesthesia and pain control. Patients were placed under sedation by the 
anesthesiologist using a standard weight-based dose of propofol and maintained on light sedation 
using a standard weight-based titration of propofol. After adequate sedation, the senior author 
injected a mixture of 5 mL of 1% lidocaine and 5 mL of 0.5% marcaine into the surgical field for 
intra-operative procedural anesthesia. All carpal tunnel releases were performed using a single 
incision endoscopic technique. 
All patients received the same standard post-operative prescriptions for pain management: 
Tylenol 1000 mg by mouth every 8 hours, naproxen 500 mg by mouth every 12 hours, and 
oxycodone 5 mg by mouth every 6 hours as needed for severe pain rated as more than 7 out of 10 
on an 11-point pain scale (0-10). Each oxycodone prescription was for 20 tablets and no refills 
were authorized. Pain surveys were distributed to the subjects on the day of surgery and the 
subjects were instructed to complete the surveys every 8 hours for 7 days after surgery. The 
subjects also noted the number of oxycodone tablets consumed per day.