E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
IN morphine Sulphate is no more effective at providing pain relief than standard (non-pariatal) ambulance treatments (null hypothesis) |
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E.2.2 | Secondary objectives of the trial |
IN morphine Sulphate reduces the distress of patients. The administration of IN morphine sulphate is acceptable to patients. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. 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).
Trial end points will be: Midnight 31st january 2006 Serious Adverse Event (trial related). Significantly small numbers recruited. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
standard ambulance treatment alone |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |