Site: The Royal Children’s Hospital
This study will look at how well nurses adhere to pain management guidelines when providing IV boluses for morphine and fentanyl in paediatrics. There are a number of aims which the study will hope to investigate in answering this question:
To determine frequency of IV boluses
To investigate how well pain management guidelines are adhered to by nurses in paediatrics
To determine the frequency of adverse events for itching, increased sedation and respiratory depression that require naloxone.
The data will look at:
– How many boluses are administered while patient is receiving IV infusion?
– The number of narcan and adverse events (itching, respiratory depression and oversedation)
– Were parameters normal or abnormal (were vitals in orange or purple areas?)
– Overall, are guidelines about IV boluses being followed?
● IV fentanyl and IV morphine infusion
● Platypus and Cockatoo wards (P=surgical ward, C=neurosurg, neuro, transplant, complex cases)
Section 7 – PARTICIPANT SAFETY AND WITHDRAWAL
7.1 RISK MANAGEMENT AND SAFETY
[Identify all areas where participant safety may be compromised, safety such examples may include, but are not limited to exposure to radiation and invoking psychological or physical distress. Safety considerations are not just physical, they can also be psychological, therefore, you must ensure for psychological distress you have arranged an appropriate contingency plan.]
7.2 HANDLING OF WITHDRAWALS
[Participants may withdraw from the study for the following reasons: participant has chosen to withdraw from the study, protocol violation, or participant has experienced an adverse event. Describe the procedures to be followed when a participant is withdrawn from the study. This should include what happens to all collected data (e.g., blood samples, scans, photos, etc.) that have already been collected, if the participant needs to have any follow-up, all administrative requirements to withdraw a subject to ensure their information isn’t inappropriately used after their withdrawal from the study]
[Describe if withdrawn participants will be replaced in the study and if not, describe what impact this will have on the statistical significance of the sample size for the study]
Section 9 – DATA SECURITY & HANDLING
9.1 DETAILS OF WHERE RECORDS WILL BE KEPT & HOW LONG WILL THEY BE STORED
[List the location/s where records will be held. If there are multiple locations, list the exact data to be held at each location. All records for non drug trials should be kept for a minimum of 5 years post study closure (final publication or presentation associated with the study), if your study contains a CTN drug/device, then records must be kept for a minimum of 15 years.]
9.2 CONFIDENTIALITY AND SECURITY
[Describe how confidentiality of all study data will be ensured via security mechanisms in place. Describe the process for data re-identification; having a separate ledger that links Code Identification numbers with Medical Record Numbers or Surname and Date of Birth. Describe why ensuring data is either non-identifiable or re-identifiable is important. Reiterate aggregate data will be analysed if appropriate, which reduces the risk of individual participants being able to be identified]
9.3 ANCILLARY DATA
[Describe how where and for how long you will store data such as videos, photographs and images, also describe how confidentiality will be ensured].