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

Not Applicable

Completed

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

• Registration Number: NCT04582032
• Lead Sponsor: Ankara City Hospital Bilkent

Brief 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?

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 Timeline

• Study First Submitted: 2020-09-28
• Study First Submitted QC: 2020-10-04
• Study First Posted: 2020-10-09
• Study Start: 2020-11-01
• Primary Completion: 2020-12-04
• Status Verified: 2021-01
• Study Completion: 2021-01-04
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexketoprofen group,	Dexketoprofen (KETAVEL 50 mg/2 ml)	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
Saline group	Saline (Isotonic Saline Solution 0.9% )	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

Primary Outcome Measures

Name	Time	Method
The injection pain due to rocuronium	1 month	Pain will be recorded and graded using a 4-point scale (none, mild, moderate, or severe).

Secondary Outcome Measures

Name	Time	Method
Score on pain due to injection of rocuronium	1 month	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.

Trial Locations

Locations (1)

Kecioren Training and Research Hospital; 🇹🇷 Ankara, Turkey