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CompletedNCT04582032Updated Jan 29, 2021

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

An interventional study of Dexketoprofen (KETAVEL 50 mg/2 ml) and Saline (Isotonic Saline Solution 0.9% ) in Injection Site Irritation, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-29.

Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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?

Read the 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?

02

Conditions studied

  • Injection Site Irritation

Keywords

  • dexketoprofen, pain, rocuronium
03

In context

Lead sponsor

Ankara City Hospital Bilkent is the lead sponsor of 424 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patients with psychiatric and mental problems
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
68 participants (actual)

Study arms

  • 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)

  • 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% )

Interventions

  • DrugDexketoprofen (KETAVEL 50 mg/2 ml)

    intravenous dexketoprofen (KETAVEL 50 mg/2 ml)

  • DrugSaline (Isotonic Saline Solution 0.9% )

    intravenous 2 ml of saline

06

What researchers measure

Primary outcomes

  1. The injection pain due to rocuronium

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

    Time frame: 1 month

Secondary outcomes

  1. 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.

    Time frame: 1 month

07

Study locations

1 site
  • Kecioren Training and Research Hospital
    Ankara, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04582032
Lead sponsor
Ankara City Hospital Bilkent
Responsible party
Mehmet sahap (Assistant professor, Ankara City Hospital Bilkent) — Principal investigator
First posted
Oct 9, 2020
Start date
Nov 1, 2020
Primary completion
Dec 4, 2020
Completion
Jan 4, 2021
Last update
Jan 29, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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