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Intranasal ketamine for moderate to severe pain in children- a dose finding study.

Phase 4
Completed
Conditions
acute pain
musculoskeletal injury
Anaesthesiology - Pain management
Injuries and Accidents - Other injuries and accidents
Registration Number
ACTRN12612000012875
Lead Sponsor
Southern Health
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
60
Inclusion Criteria

Children aged three to 13 years and under 50kg body weight

Musculoskeletal injury to upper and/or lower limbs

Visual analog pain score greater than or equal to 6/10 on the standard 11-point verbal rating scale (0 = none, 10 = worst pain imaginable) and patient would normally be considered for intranasal fentanyl administration.

Use of simple analgesia such as paracetamol or ibuprofen or inhalational methoxyflurane during ambulance transport are not exclusion criteria

Exclusion Criteria

Inability to gain informed consent from parent or guardian

Prior administration of parenteral or intranasal analgesics (morphine, fentanyl)

Prior administration of oral opioid analgesia (oxycodone, codeine)

Allergy to ketamine

Aberrant nasal anatomy

Acute or chronic nasal problems or nasal trauma that may preclude adequate administration or absorption of intranasal medication.

Presence of multiple trauma or injuries.

Sustained a head injury with loss of consciousness.
Presence of cognitive impairment.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Mean change in Visual Analog Scale pain score from pre-administration (T0) to 30 minutes post-administration (T30)[30 minutes post-administration of ketamine]
Secondary Outcome Measures
NameTimeMethod
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