S-ketamine to reduce negative pressure wound therapy dressing change associated pai

Not Applicable

• Conditions: Procedural pain related to negative pressure wound therapy dressing changes; Signs and Symptoms

• Registration Number: ISRCTN90985804
• Lead Sponsor: Helsinki University Central Hospital (Finland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-12
• Study Completion: 2021-06-30
• Last Update Posted: 5 August 2022

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Adult patients over 18 years undergoing elective negative pressure wound therapy wound dressing changes in the plastic surgery unit

Exclusion Criteria

1. Body mass index over 35
2. Unstable ischaemic cardiac disease
3. Increased intracranial pressure
4. Increased intraocular pressure
5. Gravidity
6. Lactation
7. Hypersensitivity or allergy to ketamine, fentanyl or midazolam
8. Severe psychiatric disease
9. Inability to use the Numerical Rating Scale (NRS) pain scale

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Pain measured using the NRS scale during the procedure, at the end of the procedure, and at three months after the procedure <br>2. Possible need for rescue medicine (fentanyl) during the procedure and, if needed, how much

Secondary Outcome Measures

Name	Time	Method
To evaluate and compare the possible side effects such as altered mental state, desaturation, changes in blood pressure and heart rate associated with the treatment of S-ketamine or rescue medication (fentanyl):<br>1. Confusion measured with Richmond Agitation Sedation Scale (RASS) at 30 minutes and 60 minutes after the drug investigated (S-ketamine or placebo) has been given<br>2. Saturation with pulse oximetry (SpO2 %) at 15 minutes, 30 minutes and 60 minutes after the drug investigated (S-ketamine or placebo) has been given<br>3. Hemodynamic parameters (blood pressure mmHg and pulse beats/minute) at 15 minutes, 30 minutes and 60 minutes after the drug investigated (S-ketamine or placebo) has been given