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Completed

NCT Number: NCT02313675

Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol for Carpal Tunnel and Distal Radius Fracture Surgeries

The purpose of this study is to determine the efficacy of intra-operative administration of IV tylenol and/or IV toradol in minimizing post-operative pain for carpal tunnel patients and distal radius fracture patients.

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Key information

About this study

The study population will include patients presenting for surgery with carpal tunnel syndrome as well as surgical treatment of distal radius fracture. Patients will be treated intra-operatively with either IV tylenol, IV toradol, both, or neither. All patients will receive the standard post-operative prescriptions for pain management. Daily pain surveys scoring pain from 0-10 will be distributed to the subjects to be filled out over the course of 10 days prior to first post-operative visit, usually 10-14 days later. Number of pain pills used before the first post-operative visit will also be measured.

We hypothesize that the effects of intra-operative administration of IV tylenol and/or IV toradol will have a significant effect on decreasing post-operative pain in the first 10 days following distal radius fracture surgeries, with a significant difference in pain described as at least a 2 points on a 0-10 pain scale.

We also hypothesize that intra-operative administration of IV tylenol and/or IV toradol will not have such significant effect on decreasing post-operative pain for carpal tunnel release surgery.

A secondary aim is to evaluate the post-operative opioid consumption of patients within these treatment groups. We hypothesize that opioid consumption will be decreased in the groups receiving IV tylenol and/or toradol for distal radius fracture surgery compared to the placebo group. We do not expect such a difference for the carpal tunnel release surgery group.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • carpal tunnel release surgery candidates,
  • distal radius fracture surgery candidates

Exclusion criteria

  • under 18 years of age,
  • pregnant women,
  • prisoners

Treatment and study plan

Acetaminophen

Drug

Other names: tylenol

Ketorolac Tromethamine

Drug

Other names: toradol

Saline

Drug

Primary outcomes

  1. Postoperative Pain (Pain Scores From 0-10 Scale)

    Time frame: 7 days

    This is an ordinal pain scale. The patient picks a number from 0-10 scale every 4 hours for 7 days post-operatively. 0 is no pain, 10 is the worst pain imaginable. Lower scores would be preferable to higher scores.

Secondary outcomes

  1. Opioid Consumption (Number of Pills Taken)

    Time frame: 7 days

    Daily opioid consumption assessed as number of pills taken that day, each day for 7 days post-operatively

    Outcome measure reported below is mean number of opioid pills consumed per day.

Sponsors and collaborators

Lead sponsor

John Fowler

Other

Registry information

Official study title

Comparing Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol Administration for Carpal Tunnel Release and Distal Radius Fracture Surgeries

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 10, 2014
Registry last updated
May 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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