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

• Sponsor: John Fowler (Other)
• Overall Status: Completed
• CT.gov ID: NCT02313675
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 4
• Duration (Months): 24
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain; Carpal Tunnel Release; Distal Radius Fracture	Drug: Acetaminophen; Drug: Ketorolac Tromethamine; Drug: Saline	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparing Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol Administration for Carpal Tunnel Release and Distal Radius Fracture Surgeries
• Study Start Date: May 1, 2015
• Actual Primary Completion Date: May 1, 2017
• Actual Study Completion Date: May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IV tylenol One time intra-operative IV acetaminophen administration	Drug: Acetaminophen; Other Names: tylenol
Experimental: IV toradol One time intra-operative IV ketorolac thromethamine administration	Drug: Ketorolac Tromethamine; Other Names: toradol
Experimental: IV tylenol/toradol combination One time intra-operative IV combination of acetaminophen/ketorolac administration	Drug: Acetaminophen; Other Names: tylenol ; Drug: Ketorolac Tromethamine; Other Names: toradol
Placebo Comparator: saline One time intra-operative 50ml IV normal saline administration	Drug: Saline

Outcome Measures

Primary Outcome Measures

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

1. Opioid Consumption (Number of Pills Taken) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• carpal tunnel release surgery candidates,

• distal radius fracture surgery candidates

Exclusion Criteria:

• under 18 years of age,

• pregnant women,

• prisoners

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaufmann Building	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• John Fowler

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jan 25, 2017
• Statistical Analysis Plan - Jan 25, 2017

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: John Fowler, MD, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT02313675
• Other Study ID Numbers: PRO14110464
• First Posted: Dec 10, 2014
• Last Update Posted: May 4, 2018
• Last Verified: Apr 1, 2018

• Keywords provided by John Fowler, MD, University of Pittsburgh: carpal tunnel syndrome; opioid analgesics; postoperative pain; IV tylenol; IV toradol
• Additional relevant MeSH terms: Carpal Tunnel Syndrome; Pain, Postoperative; Fractures, Bone; Radius Fractures; Acetaminophen; Ketorolac; Ketorolac Tromethamine

Study Results

Participant Flow

Arm/Group Title	IV Tylenol	IV Toradol	IV Tylenol/Toradol Combination	Saline
Arm/Group Description	One time intra-operative IV acetaminophen administration Acetaminophen	One time intra-operative IV ketorolac thromethamine administration Ketorolac Tromethamine	One time intra-operative IV combination of acetaminophen/ketorolac administration Acetaminophen Ketorolac Tromethamine	One time intra-operative 50ml IV normal saline administration Saline
Period Title: Overall Study
STARTED	11	11	11	11
COMPLETED	11	11	11	11
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	IV Tylenol	IV Toradol	IV Tylenol/Toradol Combination	Saline	Total
Arm/Group Description	One time intra-operative IV acetaminophen administration Acetaminophen	One time intra-operative IV ketorolac thromethamine administration Ketorolac Tromethamine	One time intra-operative IV combination of acetaminophen/ketorolac administration Acetaminophen Ketorolac Tromethamine	One time intra-operative 50ml IV normal saline administration Saline	Total of all reporting groups
Overall Participants	11	11	11	11	44
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	57	48	43	55	51
Sex: Female, Male (Count of Participants)
Female	8 72.7%	8 72.7%	6 54.5%	6 54.5%	28 63.6%
Male	3 27.3%	3 27.3%	5 45.5%	5 45.5%	16 36.4%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Postoperative Pain (Pain Scores From 0-10 Scale)
Description	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.
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IV Tylenol	IV Toradol	IV Tylenol/Toradol Combination	Saline
Arm/Group Description	One time intra-operative IV acetaminophen administration Acetaminophen	One time intra-operative IV ketorolac thromethamine administration Ketorolac Tromethamine	One time intra-operative IV combination of acetaminophen/ketorolac administration Acetaminophen Ketorolac Tromethamine	One time intra-operative 50ml IV normal saline administration Saline
Measure Participants	11	11	11	11
Mean (95% Confidence Interval) [units on a scale]	2.0	2.9	2.7	2.0

2. Secondary Outcome

Title	Opioid Consumption (Number of Pills Taken)
Description	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.
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IV Tylenol	IV Toradol	IV Tylenol/Toradol Combination	Saline
Arm/Group Description	One time intra-operative IV acetaminophen administration Acetaminophen	One time intra-operative IV ketorolac thromethamine administration Ketorolac Tromethamine	One time intra-operative IV combination of acetaminophen/ketorolac administration Acetaminophen Ketorolac Tromethamine	One time intra-operative 50ml IV normal saline administration Saline
Measure Participants	11	11	11	11
Mean (Full Range) [pills consumed]	0.2	0.7	1.0	0.7

Adverse Events

Time Frame	Time frame is 90 days after surgery
Arm/Group Title	IV Tylenol		IV Toradol		IV Tylenol/Toradol Combination		Saline
Arm/Group Description	One time intra-operative IV acetaminophen administration Acetaminophen		One time intra-operative IV ketorolac thromethamine administration Ketorolac Tromethamine		One time intra-operative IV combination of acetaminophen/ketorolac administration Acetaminophen Ketorolac Tromethamine		One time intra-operative 50ml IV normal saline administration Saline
All Cause Mortality
	IV Tylenol		IV Toradol		IV Tylenol/Toradol Combination		Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)		0/11 (0%)		0/11 (0%)
Serious Adverse Events
	IV Tylenol		IV Toradol		IV Tylenol/Toradol Combination		Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)		0/11 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	IV Tylenol		IV Toradol		IV Tylenol/Toradol Combination		Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)		0/11 (0%)		0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.