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Completed

NCT Number: NCT04582032

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

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?

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Key information

Conditions

Injection Site Irritation Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kecioren Training and Research Hospital

Ankara, Turkey (Türkiye)

About this study

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

  • Mild movement response to injection
  • Hand withdrawal response to injection
  • 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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexketoprofen (KETAVEL 50 mg/2 ml)

Drug

intravenous dexketoprofen (KETAVEL 50 mg/2 ml)

Saline (Isotonic Saline Solution 0.9% )

Drug

intravenous 2 ml of saline

Primary outcomes

  1. The injection pain due to rocuronium

    Time frame: 1 month

    Pain will be recorded and graded using a 4-point scale (none, mild, moderate, or severe).

Secondary outcomes

  1. Score on pain due to injection of rocuronium

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Oct 9, 2020
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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