Inhalational Ketamine compared to Entonox for moderate acute traumatic pain. A Randomized Controlled trial

Phase 3

Completed

• Conditions: Moderate traumatic pain; inhaled ketamine; entonox; trauma

• Registration Number: TCTR20210324007
• Lead Sponsor: Secretariat of Research and Innovation Faculty of Medicine UKM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-09-14
• Study Start: 2021-03-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Adults, age more than 18
Moderate acute traumatic pain (40mm score to0mm VAS)

Exclusion Criteria

GCS < 15
Weight >100kg, <40kg
Inability to self report pain severity.
Prior allergic sensitivity to ketamine.
Pregnancy
Known underlying psychiatric illness
BP >180/100
Patients with head injury complaining of loss of consciousness, dizziness,
vomiting/nausea (excluded despite evidence that ketamine does not exacerbate
intracranial haemorrhage)
Hemodynamically instable.
History of recreational drug abuse
History of significant heart, hepatic, lung, epilepsy condition.
Other contraindication to Entonox
Maxillofacial injuries
Artificial, traumatic or spontaneous pneumothorax
Air embolism
Middle ear occlusion, ear infection.
Decompression sickness
Following a recent underwater dive
Abdominal distention/ intestinal obstruction.
Other contraindication to ketamine
Increase intraocular pressure

Study & Design

• Study Type: Interventional
• Study Design: Not specified