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

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

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?

Study Overview

• Status: Completed
• Conditions: Injection Site Irritation
• Intervention / Treatment: Drug: Dexketoprofen (KETAVEL 50 mg/2 ml); Drug: Saline (Isotonic Saline Solution 0.9% )

Detailed 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?

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Keçiören Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexketoprofen group,; IV cannulation was performed on hand dorsum or brachial and canulation place was recorded. Patients allocated in dexketoprofen group were administered intravenous dexketoprofen (50 mg/2ml) and 0,3 mg/kg midazolam 10 minutes prior to general anesthesia induction	Drug: Dexketoprofen (KETAVEL 50 mg/2 ml); intravenous dexketoprofen (KETAVEL 50 mg/2 ml)
Other: Saline group; IV cannulation was performed on hand dorsum or brachial and canulation place was recorded. Patients allocated in control group were administered intravenous 2 ml of saline and 0,3 mg/kg midazolam 10 minutes prior to general anesthesia induction	Drug: Saline (Isotonic Saline Solution 0.9% ); intravenous 2 ml of saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): December 4, 2020
• Study Completion (Actual): January 4, 2021

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: October 4, 2020
• First Posted (Actual): October 9, 2020

Study Record Updates

• Last Update Posted (Actual): January 29, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: dexketoprofen, pain, rocuronium
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dexketoprofen trometamol
• Other Study ID Numbers: roc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No