ACTRN12617001490369CompletedPhase 1
Palatable and chewable tramadol chocolate-based tablets for pain management in paediatric patients
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Princess Margaret Hospital
- Enrollment
- 147
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 3 Years to 16 Years (—)
- Sex
- All
Inclusion Criteria
- •Male or female, 3 to 16 years of age
- •Treating anaesthetist considering patient suitable for pre-procedural tramadol
- •Obtained informed parental or guardian consent and child assent where appropriate
Exclusion Criteria
- •Known allergy to chocolate (chocolate base does not contain nuts)
- •Known allergy/intolerance to tramadol or opioids
- •Unable to understand the information sheet and the consent form
- •Patient taking medication known to interact with tramadol (e.g. serotonergic agents, warfarin, ketoconazole)
- •Known significant renal or hepatic impairment
- •Known seizure disorder or epilepsy
- •Participants undergoing surgeries that remove the tonsils or adenoids.
- •Obese (as detailed by a BMI percentile above the 95th)
- •Known severe obstructive sleep apnoea as documented by an overnight sleep study
- •Known severe respiratory disease with significant impact on daily life
Investigators
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