EUCTR2005-002308-40-GBActive, not recruitingNot Applicable
Evaluation of Intranasal (IN) Morphine Sulphate as a Paramedic Administered Analgesic for Children in the Pre-Hospital Environment - Intranasal (IN) Morphine for Pre-Hospital Paediatric Analgesia
niversity of Plymouth0 sites80 target enrollmentStarted: July 25, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 80
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Children between 3 and 14 years old, in moderate to severe pain. (14 maximum for concentration of morphine available)
- •Parent in attendance and willing and able to give written consent.
- •Treatment to hospital time over 20 minutes (to allow data to be collected)
- •For patient of 8 years and older, willing and able to give verbal consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Patient (and child if >8) not able to understand English
- •Known hypersensitivity to morphine
- •Patient requiring pre-hospital IV access
- •Patient with a blocked nose or an upper respiratory tract infection
- •Patients with learning disabilities
- •Patients who are blind or visually impaired
- •Previous inclusion in the study
- •Patients with any data sheet contra-indications to morphine
- •Hypertension (appropriate for age)
- •Patients who have taken any opiod analgesia in previous 48 hours
- •Child unwilling to have treatment
- •These have been drawn from the existing JRCALC morphine protocol, with additional criteria for IN administration as used in the IN diamophine protocols developed for NHS A&E units.
Investigators
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