Efficacy of Intravenous Dexketoprofen and Tenoxicam on Pr... | NCT02285972

Studies
Efficacy of Intravenous Dexketoprofen and Tenoxicam on Propofol Associated Injection Pain

NCT02285972

Sponsor

Ordu University

Status

Completed

Last Update Posted

Apr 21, 2015Estimated

Enrollment

118Actual

Phase

Phase 4

Conditions

Injection Pain

Interventions

saline
dexketoprofen
tenoxicam

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Nov 1, 2014

First Submission Date that Met QC Criteria

Nov 4, 2014

First Posted Date

Nov 7, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2015

Last Update Posted Date

Apr 21, 2015Estimated

Description Module

Brief Summary

Propofol remains the most common drug for induction of general anaesthesia, although it causes considerable pain or discomfort on injection. Anesthesia providers have attempted a large number of remedies to prevent this pain on injection. Previously explored ideas include injecting propofol into larger veins, warming of the hand with hot packs, and intravenous pretreatment with numerous other medications. No studies to date have looked at the dexketoprofen and tenoxicam for the pretreatment of pain on injection caused by propofol. The investigators propose studying the use of dexketoprofen and tenoxicam for pretreatment of propofol related pain on injection.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

118Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
saline	Placebo Comparator	Drug: saline
dexketoprofen	Active Comparator	Drug: dexketoprofen
tenoxicam	Active Comparator	Drug: tenoxicam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
saline	Drug	before the anesthesia induction, 2mL saline iv injection	saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Verbal Pain Score		Approximately one minute following administration of propofol.
Facial Pain Score		Approximately one minute following administration of propofol.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

American Society of Anesthesiologists (ASA) physical status 1 and 2
18 - 65 years
general anesthesia scheduled for elective surgery

Exclusion Criteria:

age < 18 years, > 65 years
pregnancy
patients requiring a rapid sequence induction
refusal to participate and patients already participating in another study
allergy to study drugs
communication difficulty
psychiatric and neurolojic disorders
use of analgesics or sedative drugs within 24 hours before surgery.
emergency surgery
history of drug or alcohol abuse
ASA 3 and above

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital		Altinordu	Ordu	52100	Turkey (Türkiye)

Intervention Browse Module

MeSH Terms

ID	Term
D012965	Sodium Chloride
C118296	dexketoprofen trometamol
C032801	tenoxicam

Ancestor Terms

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided