Effects of Cyclooxygenase (COX) 1-2 Inhibitors on Prevention of Rocuronium Injection Pain

Injection Site Irritation Clinical Trial

Official title:

Effects of COX 1-2 Inhibitors on Prevention of Rocuronium Injection Pain: Controlled, Randomised, Double Blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04582032
• Other study ID #: roc
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: January 4, 2021

Study information

• Verified date: January 2021
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Purpose : The aim of the study is to investigate the effects of cox inhibitors as a rescue agent against the rocuronium pain Methodology : Sixty patients enrolled for the general anesthesia enrolled in this study. Patients were allocated into two groups (Group 1: Dexketoprofen group, Group 2: Control group) .Pain was evaluated by during rocuronium injection, patients were scored by a scale showed below. 0;No movement response to injection 1. Mild movement response to injection 2. Hand withdrawal response to injection 3. Arm withdrawal response to injection Investigators also evaluated the pain with 2 questions when the patient was in the recovery room. Question 1.What was the last feeling before participants fall into sleep? question 2. Did participants feel any pain on participants's hand during medication injection for anesthesia?

Description:

Purpose : Rocuronium bromide is a painful agent while general anesthesia induction. The aim of the study is to investigate the effects of cox inhibitors as a rescue agent against the rocuronium pain Methodology : Sixty patients enrolled for the general anesthesia enrolled in this study. Patients were allocated into two groups (Group 1: Dexketoprofen group, Group 2: Control group) .Pain was evaluated by during rocuronium injection, patients were scored by a scale showed below. 0;No movement response to injection 1. Mild movement response to injection 2. Hand withdrawal response to injection 3. Arm withdrawal response to injection Investigators also evaluated the pain with 2 questions when the patient was in the recovery room. Question 1.What was the last feeling before participants fall into sleep? question 2. Did participants feel any pain on participants's hand during medication injection for anesthesia?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: January 4, 2021
• Est. primary completion date: December 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• non allergic to dexketoprofen
• 18-60 years old
• American Society of Anesthesiologists(ASA) 1-2-3
• 70-90 kg weigh

Exclusion Criteria:

• patients with psychiatric and mental problems

Related Conditions & MeSH terms

• Injection Site Irritation

Intervention

Drug:
• Dexketoprofen (KETAVEL 50 mg/2 ml)
intravenous dexketoprofen (KETAVEL 50 mg/2 ml)
• Saline (Isotonic Saline Solution 0.9% )
intravenous 2 ml of saline

Locations

Country	Name	City	State
Turkey	Kecioren Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The injection pain due to rocuronium	Pain will be recorded and graded using a 4-point scale (none, mild, moderate, or severe).	1 month
Secondary	Score on pain due to injection of rocuronium	Withdrawal reactions are scored as follows: (a) no pain response, (b)pain limited to the wrist, (c) pain limited to the elbow/shoulder, or (d) generalized pain response.	1 month