NCT02313675

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at below P25 for phase_4 postoperative-pain

Timeline
Completed

Started May 2015

Typical duration for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 10, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
1 year until next milestone

Results Posted

Study results publicly available

May 4, 2018

Completed
Last Updated

May 4, 2018

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

December 8, 2014

Results QC Date

February 20, 2018

Last Update Submit

April 3, 2018

Conditions

Postoperative PainCarpal Tunnel ReleaseDistal Radius Fracture

Keywords

carpal tunnel syndromeopioid analgesicspostoperative painIV tylenolIV toradol

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Opioid Consumption (Number of Pills Taken)

    7 days

Study Arms (4)

IV tylenol

EXPERIMENTAL

One time intra-operative IV acetaminophen administration

Drug: Acetaminophen

IV toradol

EXPERIMENTAL

One time intra-operative IV ketorolac thromethamine administration

Drug: Ketorolac Tromethamine

IV tylenol/toradol combination

EXPERIMENTAL

One time intra-operative IV combination of acetaminophen/ketorolac administration

Drug: AcetaminophenDrug: Ketorolac Tromethamine

saline

PLACEBO COMPARATOR

One time intra-operative 50ml IV normal saline administration

Drug: Saline

Interventions

AcetaminophenDRUG
Also known as: tylenol
IV tylenolIV tylenol/toradol combination
Ketorolac TromethamineDRUG
Also known as: toradol
IV toradolIV tylenol/toradol combination
SalineDRUG
saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaufmann Building

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (4)

  • 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. doi: 10.1034/j.1399-6576.2003.00046.x.

    PMID: 12631041BACKGROUND

  • 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.

    PMID: 24654353BACKGROUND

  • 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.

    PMID: 21627768BACKGROUND

  • 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. doi: 10.1093/bja/ael084. Epub 2006 Apr 13.

    PMID: 16613928BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeWrist FracturesCarpal Tunnel Syndrome

Interventions

AcetaminophenKetorolac TromethamineSodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsWrist InjuriesArm InjuriesWounds and InjuriesFractures, BoneMedian NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and Strains

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesIndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
John R Fowler, MD
Organization
University of Pittsbur
fowlerjr@upmc.edu
412-605-3245

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 8, 2014

First Posted

December 10, 2014

Study Start

May 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 4, 2018

Results First Posted

May 4, 2018

Record last verified: 2018-04

Locations

US(1)