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

• Conditions: This research hopes to bridge the gap between in-hospital diamorphine and pre-hospital IV morphine by developing IN morphine for administration to children between 3 and 14 years old. This will allow effective non parental opiod analgesia to be used by paramedics.Main inclusion will be for children who are within paramedic IV morphine protocol, but who are refusing cannulation or for whom cannulation would be technically difficult or would cause unnecessary distress.

• Registration Number: EUCTR2005-002308-40-GB
• Lead Sponsor: niversity of Plymouth

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-25
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: IN morphine Sulphate is no more effective at providing pain relief than standard (non-pariatal) ambulance treatments (null hypothesis);Secondary Objective: IN morphine Sulphate reduces the distress of patients.<br>The administration of IN morphine sulphate is acceptable to patients.;Primary end point(s): En route to hospital patients will have their pain, distress, anxiety and distress monitored by accepted measures by a paramedic. Patient will then be handed over to nursing/medical staff at A&E. This point will determine the end of the trial for that patient.<br>Other patient end points will also be the administration of IV morphine, or a point 30 minutes after administration, when trial monitoring will stop (although normal care will continue).<br><br>Trial end points will be:<br>Midnight 31st january 2006<br>Serious Adverse Event (trial related).<br>Significantly small numbers recruited.