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

S-ketamine to reduce negative pressure wound therapy dressing change associated pain: a prospective, randomized, blinded cross-over study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN90985804

Enrollment

Registered

2013-12-12

Start date

2014-04-01

Completion date

Unknown

Last updated

2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Procedural pain related to negative pressure wound therapy dressing changes Signs and Symptoms

Interventions

1. Intervention group: S-ketamine dose 0.25 mg/kg will be administered during negative pressure wound therapy dressing change in addition to local anaesthesia 2. Control group: placebo (saline) The w

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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): 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 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 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	—

Measure

Time frame

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): 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 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 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

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Countries

Finland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026