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Phase 4 N=140 Randomized Double-blind Treatment

Acetaminophen/Codeine vs Acetaminophen/Ibuprofen for Pain Control and Patient Satisfaction After Hand Surgery

Pain, Postoperative

Bottom Line

View on ClinicalTrials.gov: NCT02647788 ↗
Enrolled (actual)
140
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score — 2.90; 3.51; 2.36; 2.40 score on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Acetaminophen/Ibuprofen (Drug); Acetaminophen/Codeine (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Pennsylvania
Primary completion
Jan 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score		 2.90; 3.51; 2.36; 2.40; 1.69; 2.26 —
SECONDARY
Quality of Recovery-9 (QoR-9).		 16.91; 16.65 —
SECONDARY
Number of Pills Used		 13.72; 14.14 —

Summary

The purpose of this research study is to find out if taking Acetaminophen with Ibuprofen (e.g. Tylenol + Advil), a non-opioid regimen, provides the same type of pain relief after hand surgery compared to Acetaminophen and codeine (e.g. Tylenol 3), an opioid regimen.

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing ambulatory hand surgery for carpal tunnel and trigger finger, under local anesthesia with or without sedation.

Exclusion Criteria

  • ASA> 3;
  • Coagulopathy;
  • Renal disease,
  • Liver disease,
  • History of recent gastro-intestinal bleeding
  • Pregnancy.
  • Diagnosis of chronic pain currently taking opioid pain medication or with a history of drug abuse.
  • Patients with a self-described allergy to ASA, acetaminophen, NSAIDS and codeine.
  • All patients receiving a brachial plexus block for anesthesia and/or analgesia
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02647788). 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.

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