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Oral morphine versus transmucosal diamorphine for breakthrough pain in children: methods and outcomes: UK (DIPPER
Emily Harrop1,2, Christina Liossi3,4, Liz Jamieson5,6
1Helen and Douglas House Hospice, Oxford, UK.
Insights
Consensus was reached on using the buccal route for transmucosal diamorphine to manage breakthrough pain in children. Standardized pain scales were chosen to inform future pediatric palliative care trials.
Area of Science:
- Palliative Care
- Pediatric Pain Management
- Clinical Trial Design
Background:
- No randomized controlled trials exist for breakthrough pain in pediatric palliative care.
- Standardized outcome measures for pediatric breakthrough pain are lacking.
- This study aimed to inform a future randomized controlled trial on opioid administration for breakthrough pain in children.
Purpose of the Study:
- To achieve consensus on design aspects for a prospective study.
- To inform a future randomized controlled trial comparing oral morphine and transmucosal diamorphine.
- To establish feasibility for a randomized controlled trial in pediatric palliative care.
Main Methods:
- Nominal group technique used to achieve consensus.
- Expert panel included 10 clinicians and 3 parent representatives.
- Consensus defined as agreement with no further participant comments.
Main Results:
- The buccal route was favored for administration.
- Dosing followed the Association for Paediatric Palliative Medicine formulary.
- The verbal Numerical Rating Scale, Faces Pain Scale-Revised, and FLACC/FLACC-Revised were selected for pain measurement.
Conclusions:
- Consensus was reached for a small-scale prospective cohort study.
- The study provides essential information for designing a future randomized controlled trial.
- This work addresses the need for standardized outcome measures in pediatric palliative care.
Objectives:
No randomised controlled trials have been conducted for breakthrough pain in paediatric palliative care and there are currently no standardised outcome measures. The DIPPER study aims to establish the feasibility of conducting a prospective randomised controlled trial comparing oral and transmucosal administration of opioids for breakthrough pain. The aim of the current study was to achieve consensus on design aspects for a small-scale prospective study to inform a future randomised controlled trial of oral morphine, the current first-line treatment, versus transmucosal diamorphine.
Methods:
The nominal group technique was used to achieve consensus on best practice for mode of administration, dose regimen and a range of suitable pain intensity outcome measures for transmucosal diamorphine in children and young people with breakthrough pain. An expert panel of ten clinicians in paediatric palliative care and three parent representatives participated. Consensus was achieved when agreement was reached and no further comments from participants were forthcoming.
Results:
The panel favoured the buccal route of administration, with dosing according to the recommendations in the Association for Paediatric Palliative Medicine formulary (fifth Edition, 2020). The verbal Numerical Rating Scale was selected to measure pain in children 8 years old and older, the Faces Pain Scale-Revised for children between 4 and 8 years old, and Face, Legs, Activity, Cry and Consolability (FLACC)/FLACC-Revised as the observational tools.
Conclusions:
The nominal group technique allowed consensus to be reached for a small-scale, prospective, cohort study and provided information to inform the design of a randomised controlled trial.
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