NCT03509857

Brief Summary

In this study, the investigators seek to evaluate the role of vibration in the reduction of discomfort associated with painful stimulus associated with anesthesia induction. Through this study, the investigators hope to develop a comprehensive and cost-effective approach to minimize patient discomfort during anesthesia induction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

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

January 4, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 26, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

September 27, 2022

Completed
Last Updated

September 27, 2022

Status Verified

September 1, 2022

Enrollment Period

10 months

First QC Date

January 4, 2018

Results QC Date

October 22, 2021

Last Update Submit

September 9, 2022

Conditions

Pain, Acute

Keywords

PainAcute painAnalgesiaPropofol infusion

Outcome Measures

Primary Outcomes (1)

  • Level of Pain as Observed by Two Independent Observers Following Propofol Injection, With or Without a Vibration Analgesia Adjunct

    Patient pain will be assessed by two independent observers, an attending anesthesiologist and a certified registered nurse anesthetist (CRNA). Pain was graded using a four-point pain manifestation scale described by McCrirrick \& Hunter : 0 = none (negative response to questioning), 1 = mild (pain reported in response to questioning only, without any behavioral signs), 2 = moderate (pain reported in response to questioning and accompanied by a behavioral sign, or pain reported spontaneously without questioning), 3 = severe (strong vocal response or response accompanied by facial grimacing, arm withdrawal or tears). Higher scores meaning worse outcome (perceived pain) and lower score meaning better outcome.

    Day 1 at time of propofol injection

Study Arms (2)

normal standard of care infusion of propofol without analgesia

PLACEBO COMPARATOR

normal standard of care infusion of propofol without analgesia

Other: No Intervention

infusion of propofol with application of vibration analgesia

EXPERIMENTAL

infusion of propofol with application of vibration analgesia

Device: BUZZY(tm)

Interventions

BUZZY(tm)DEVICE

Risks associated with the BUZZY(tm) device The intervention group will receive vibration only, with application of the BUZZY device just proximal to the intravenous infusion site immediately before and during propofol infusion. There are no known risks for the use of the BUZZY(tm) device, which is registered as an FDA class III device ("therapeutic massager").

infusion of propofol with application of vibration analgesia
No InterventionOTHER

No intervention

normal standard of care infusion of propofol without analgesia

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Those aged 18 to 100 who are going to receive propofol injection as part of induction of anesthesia for surgery

You may not qualify if:

  • Those below the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Hutchinson Campus

The Bronx, New York, 10461, United States

Location

Related Publications (9)

  • Baxter AL, Cohen LL, McElvery HL, Lawson ML, von Baeyer CL. An integration of vibration and cold relieves venipuncture pain in a pediatric emergency department. Pediatr Emerg Care. 2011 Dec;27(12):1151-6. doi: 10.1097/PEC.0b013e318237ace4.

    PMID: 22134226BACKGROUND

  • Bini G, Cruccu G, Hagbarth KE, Schady W, Torebjork E. Analgesic effect of vibration and cooling on pain induced by intraneural electrical stimulation. Pain. 1984 Mar;18(3):239-248. doi: 10.1016/0304-3959(84)90819-4.

    PMID: 6203084BACKGROUND

  • Depue K, Christopher NC, Raed M, Forbes ML, Besunder J, Reed MD. Efficacy of intravenous lidocaine to reduce pain and distress associated with propofol infusion in pediatric patients during procedural sedation. Pediatr Emerg Care. 2013 Jan;29(1):13-6. doi: 10.1097/PEC.0b013e31827b227e.

    PMID: 23283255BACKGROUND

  • Grauers A, Liljeroth E, Akeson J. Propofol infusion rate does not affect local pain on injection. Acta Anaesthesiol Scand. 2002 Apr;46(4):361-3. doi: 10.1034/j.1399-6576.2002.460405.x.

    PMID: 11952433BACKGROUND

  • Kakigi R, Shibasaki H. Mechanisms of pain relief by vibration and movement. J Neurol Neurosurg Psychiatry. 1992 Apr;55(4):282-6. doi: 10.1136/jnnp.55.4.282.

    PMID: 1583512BACKGROUND

  • Lee JR, Jung CW, Lee YH. Reduction of pain during induction with target-controlled propofol and remifentanil. Br J Anaesth. 2007 Dec;99(6):876-80. doi: 10.1093/bja/aem293.

    PMID: 18006530BACKGROUND

  • Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available.

    PMID: 5320816BACKGROUND

  • Nanitsos E, Vartuli R, Forte A, Dennison PJ, Peck CC. The effect of vibration on pain during local anaesthesia injections. Aust Dent J. 2009 Jun;54(2):94-100. doi: 10.1111/j.1834-7819.2009.01100.x.

    PMID: 19473149BACKGROUND

  • Stinson JN, Kavanagh T, Yamada J, Gill N, Stevens B. Systematic review of the psychometric properties, interpretability and feasibility of self-report pain intensity measures for use in clinical trials in children and adolescents. Pain. 2006 Nov;125(1-2):143-57. doi: 10.1016/j.pain.2006.05.006. Epub 2006 Jun 13.

    PMID: 16777328BACKGROUND

MeSH Terms

Conditions

Acute PainPainAgnosia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Results Point of Contact

Title
Dr. Aravind Pothula
Organization
Montefiore MC
apothula@montefiore.org
9178015577

Study Officials

  • Aravind Pothula

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 4, 2018

First Posted

April 26, 2018

Study Start

February 1, 2019

Primary Completion

November 30, 2019

Study Completion

November 30, 2019

Last Updated

September 27, 2022

Results First Posted

September 27, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)