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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02313675
Other study ID # PRO14110464
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 2015
Est. completion date May 1, 2017

Study information

Verified date April 2018
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date May 1, 2017
Est. primary completion date May 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- carpal tunnel release surgery candidates,

- distal radius fracture surgery candidates

Exclusion Criteria:

- under 18 years of age,

- pregnant women,

- prisoners

Study Design


Intervention

Drug:
Acetaminophen

Ketorolac Tromethamine

Saline


Locations

Country Name City State
United States Kaufmann Building Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
John Fowler

Country where clinical trial is conducted

United States, 

References & Publications (4)

Alhashemi JA, Daghistani MF. Effects of intraoperative i.v. acetaminophen vs i.m. meperidine on post-tonsillectomy pain in children. Br J Anaesth. 2006 Jun;96(6):790-5. Epub 2006 Apr 13. — View Citation

Baley K, Michalov K, Kossick MA, McDowell M. Intravenous acetaminophen and intravenous ketorolac for management of pediatric surgical pain: a literature review. AANA J. 2014 Feb;82(1):53-64. Review. — View Citation

Hahn TW, Mogensen T, Lund C, Jacobsen LS, Hjortsoe NC, Rasmussen SN, Rasmussen M. Analgesic effect of i.v. paracetamol: possible ceiling effect of paracetamol in postoperative pain. Acta Anaesthesiol Scand. 2003 Feb;47(2):138-45. — View Citation

Smith HS. Perioperative intravenous acetaminophen and NSAIDs. Pain Med. 2011 Jun;12(6):961-81. doi: 10.1111/j.1526-4637.2011.01141.x. Epub 2011 May 31. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative Pain (Pain Scores From 0-10 Scale) 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. 7 days
Secondary Opioid Consumption (Number of Pills Taken) 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.
7 days
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