Anxiety prior to general anaesthesia Surgery
Conditions
Interventions
Current interventions as of 23/10/2020:
This study:
1. Has two arms: melatonin vs midazolam
2. Is a parallel design i.e. patients will be allocated at a 1:1 ratio between the two arms
3. Is double b
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 23/10/2020: 1. Children aged 3-14 years undergoing elective dental, ophthalmological or ENT surgery under general anaesthesia 2. Pragmatically assessed by healthcare professionals as requiring premedication as per local standard care for high/expected high levels of preoperative distress prior to elective dental/ENT/ophthalmological surgery under general anaesthetic, including known negative experiences, failed anaesthesia, parents displaying high levels of distress, additional/special needs or judged as unable to tolerate general anaesthetic without premedication 3. ASA grades I & II 4. Parent or person with parental responsibility able to give written, informed consent and child willing to assent _____ Previous inclusion criteria: 1. Children aged 5-14 years undergoing elective dental, ophthalmological or ENT surgery under general anaesthesia 2. Pragmatically assessed by healthcare professionals as requiring premedication as per local standard care for high/expected high levels of preoperative distress prior to elective dental/ENT/ophthalmological surgery under general anaesthetic, including known negative experiences, failed anaesthesia, parents displaying high levels of distress, additional/special needs or judged as unable to tolerate general anaesthetic without premedication 3. ASA grades I & II 4. Parent or person with parental responsibility able to give written, informed consent and child willing to assent
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 23/10/2020: 1. Not undergoing elective, day-case dental, ophthalmological or ENT surgery under general anaesthesia 2. Not displaying level of anxiety that would usually warrant premedication under the standard NHS care pathway 3. Reason for premedication other than anxiety 4. Current prescription of melatonin, midazolam or other non-permitted drug (please see protocol) 5. Obstructive sleep apnoea 6. ASA grades III, IV & V 7. Severe learning disability rendering child unable to communicate even with specialised support 8. Parent declines for their child to participate in the trial _____ Previous exclusion criteria: 1. Not undergoing elective, day-case dental, ophthalmological or ENT surgery under general anaesthesia 2. Not displaying level of anxiety that would usually warrant premedication under the standard NHS care pathway 3. Reason for premedication other than anxiety 4. Current prescription of melatonin, midazolam or other non-permitted drug (please see section 7.11.2) 5. Obstructive sleep apnoea 6. ASA grades III, IV & V 7. Severe learning disability rendering child unable to communicate even with specialised support
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Preoperative distress measured using the modified Yale Preoperative Anxiety Scale (mYPAS); Timepoint(s): baseline, start of transfer to TAU, entry to TAU, administration of anaesthesia | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: 1. Mortality measured using PAED assessment post-surgery 2. Post-surgical recovery measured using VSR and FPS-R post-surgery 3. Post-discharge behaviour measured using PHBQ at 14 days follow-up 4. Analgesia requirements and adverse events measured using the concomitant medication and adverse events collected pre-, during and post-surgery 5. Orientation and cognitive/psychomotor function measured using the cooperation score post-surgery 6. Serious adverse events reported at pre- and post-surgery and 14 days Efficacy: 1. Anaesthetic turnaround time and recovery time measured using time of induction of anesthesia, time of surgery completion and time to discharge 2. Anaesthetic failure rate measured using anaesthesia abandonment cases pre-surgery Qualitative: 1. Recruitment experiences and acceptability of the two drugs assessed using responses from interviews with patients and stakeholders at interviews held post the 14 days follow-up Economic: 1. The cost-effectiveness of introducing melatonin, compared to midazolam, over the study period. A decision tree model will be developed to estimate cost-effectiveness and cost per QALY over a 1-year period | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed