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National Clinical Guideline Centre (UK). Sedation in Children and Young People: Sedation for Diagnostic and Therapeutic Procedures in Children and Young People [Internet]. London: Royal College of Physicians (UK); 2010 Dec. (NICE Clinical Guidelines, No. 112.)

7Swimming in the sea of uncertainty in relation to sedation experience for children and young people undergoing diagnostic and therapeutic procedures

“To study the phenomenon of disease without books is to sail an uncharted sea, whilst to study books without patients is not to go to sea at all”

Osler (circa 1900)

7.1. Introduction

The importance of patient input to healthcare is not underestimated, but rarely is it properly achieved in providing real-time comment on how the experience has been shaped and the resultant impact of this experience on the patient's approach to future healthcare interventions. Whilst this has been achieved in adult populations to varying degrees of success, in the children's and young people population this is extremely rare, and little is reported in the literature. Having children and young people represented on the GDG is of course standard practice in NICE guideline development, but this has almost uniquely been through advocacy of carers. In trying to understand the challenges of providing a safe and effective sedation service, this feedback is crucial in determining how experts interpret evidence and remain sensitive to key clinical issues that impact on the child or young person receiving sedation. Early in development the NCGC in supporting this guideline and with the agreement from NICE made an ambitious decision to try and establish a snapshot of what it is like to be a child receiving sedation across a range of clinical contexts. The benefit of collecting real-time feedback in informing and shaping recommendations for practice is self evident, and through engagement with a developing methodology (National Paediatric Toolkit), the NCGC commissioned some primary data collection at Alder Hey Children's NHS Foundation Trust. The Trust is well positioned as England's first paediatric health promoting hospital accredited by the World Health Organisation and is one of Europe's biggest and busiest children's hospitals, providing care for over 200,000 children each year.

7.2. Development and conduct of the survey

The survey was carried out as part of a pilot project, with this particular survey focus being added to a menu of surveys administered within the Trust. The content of the survey was shaped by a subgroup of the GDG, with clinicians, technical team members and both patient carer representatives involved in the shaping of the questions asked. These were reviewed and signed off in consultation with the rest of the GDG and NICE, and were targeted at children undergoing painful and non-painful procedures requiring sedation. The questionnaire was administered using the National Paediatric Toolkit (NPT) software via hand-held, touch screen computers, a developing technology that is easy to use by even young children (over the age of four).

The NPT concept has been developed by Alder Hey Children's NHS Foundation Trust in partnership with Priority Research Ltd; throughout its development, children and young people were closely involved and contributed many ideas which have been incorporated into the current data collecting system.

The NPT was considered the system of choice for administering this survey because of a variety of unique advantages that it offers. These include:

  • an engaging, cartoon format to maintain children's interest
  • a large array of over 900 pre-defined questions, each worded differently for four developmental levels
  • all questions available in eleven languages
  • full voice-over for all text in all languages
  • Disability Discrimination Act (1995) compliant for sensory, visual and hearing impairment
  • real-time data collection and reporting.

The pilot ran from early November 2009 for 4 months and was conducted by experienced Alder Hey staff members previously engaged in similar types of data collection using the NPT.

7.3. Survey conduct approval

Patient opinion surveys are growing increasingly in both their conduct and importance, and this helps shape and reshape service delivery in different care settings. Contextually, until recently, this type of opinion seeking would have been viewed as primary research activity and therefore requiring ethics approval via a local committee or through a national committee, particularly relevant if this were multicentre research. Following changes in approach, seeking patient opinion is more latterly viewed as part of a quality improvement cycle, and is becoming more and more embedded into routine NHS Trust processes.

For this survey, approval and advice was sought and gained from Alder Hey NHS Foundation Trust's Head of Research and Ethics, Dr Matthew Peak.

7.4. Recruitment

A total of 70 patients undergoing a wide range of procedures were invited to take part, and 63 consented to do so. All departments and clinical areas within the hospital where patients receive sedation participated in the pilot.

7.5. Limitations of the survey

The limitations of the survey are important to note as this methodology will only describe the experience of the target population in one place at one time event. The ‘snapshot’ nature if surveys are extremely useful in determining the nature of patient experience and care interventions on a particular day. These cannot be generalised to other settings but findings are extremely helpful if repeat measurement is established so that a time series of events are recorded. Data are also useful, as in this case, when supporting other data (clinical and cost effectiveness reviews, consensus development), because when triangulated with this ‘other’ data inevitably enables the GDG in this case to build a clearer picture of what is happening and how to plan improvements in care and experience outcome.

7.6. Summary of main findings

7.6.1. Demographics

  • The sample had an even spread of male and female children (44% male, 46% female, 10% not recorded) and covered a broad age range from under 4 to over 16 years of age.
  • All except one were accompanied by a parent or carer, and for those children who could not complete the questionnaire themselves, a parent or carer were in a good position to do so (as expected, this was mostly younger children). Acceptability and usability of the system was such that nearly 1 in 4 (22%) of the under 4 age group were able to complete the survey themselves.
  • Of the 23 children aged 9 and over, only one child aged eleven did not complete the survey themselves.
  • Only four children (6%) were of black or minority ethnic origin.

7.6.2. Clinically relevant data

The most frequent clinical areas, accounting for almost two thirds of the sample, were:

  • burns (21%)
  • medical and renal day cases (17%)
  • radiology (16%)
  • accident and emergency (10%).

The most common agents used for sedation were:

Five procedures accounted for over half of the sample:

  • change of wound dressings (22%)
  • urodynamics (11%)
  • intra-articular steroid injections (10%)
  • cannulation (6%)
  • removal of chest drains (6%).

7.6.3. Experience of children and young people receiving sedation

Ratings of satisfaction with information and consent issues were high:

  • The people looking after me were nice to me and helped me feel OK (98%).
  • I was told everything I wanted to know about what would happen (97%).
  • I was told enough about the sedation (medicine that would make me feel OK and sleepy) (95%).
  • I had time to ask any questions I wanted (91%).
  • I was told enough about how I might feel (89%).
  • I was taught things I could do to help me feel OK with what would happen (78%).

Patients were asked to rank their experience of pain, fear and upset on a six-point scale from ‘Not at all’ to ‘As much as I can imagine’. The criterion for a positive result was a rating in the two lowest categories, that is ‘Not at all’ or ‘Just a little bit’.

  • Before the procedure, 56% were either not scared or just a little bit scared, and 11% said ‘As much as I can imagine’.
  • After receiving sedation, these figures were 80% and zero respectively.
  • 70% reported no or little pain after sedation, and 86% no or little upset afterwards.

7.6.4. Other outcomes of interest

As would be expected, the degree of amnesia was dependent on the agent used; 13 of the 16 respondents who said they remembered “everything” had received Entonox, whilst of the 13 who received the benzodiazepine, five remembered “nothing” and five “just a little bit”.

Post procedural nausea was related only to the degree of upset felt afterwards; those who felt more upset were more likely to report nausea (p = 0.019) but the direction of causality is not clear.

Only four patients said that they would not want to receive sedation again if undergoing the same procedure; this was significantly related to only two variables, both ratings of distress during the procedure after sedation. All four reported more than “just a little” pain during the procedure (p = 0.006) and being more than “just a little bit” scared (p = 0.001).

Demographics: Gender.

Demographics: Gender

Base: N = 63

The sample had an even spread of male and female patients and covered a broad age range. All except one were accompanied by a parent or carer.

Demographics: Age range of participants.

Demographics: Age range of participants

Base: N = 63

Demographics: Ethnic origin

Base: N = 63

WhiteMixedAsian or Asian BritishBlack or Black BritishOther
BritishIrishOther WhiteWhite & Black CaribbeanWhite & Black AfricanWhite & AsianOther mixedIndianPakistaniBangladeshiChineseOther AsianCaribbeanAfricanOther blackOther ethnic groupGypsy or travellerN/RBase
%791.61.601.6001.600000000014100
N501101001000000000963
Demographics: Percentage of children completing the survey themselves.

Demographics: Percentage of children completing the survey themselves

Base: N = 63

Parents or carers assisted children who could not complete the questionnaire themselves, and as would be expected this was mostly the younger children. Nevertheless, the acceptability of the system was such that 22% of the under fours were able to complete the survey themselves.

Of the 23 children aged 9 years and over, only one child aged eleven did not complete the survey themselves.

Demographics: Range of clinical areas relating to the child or young person's procedural sedation

Base: N = 63

Clinical areaN%
Medical & renal day cases1117
Burns 11117
Radiology1016
Accident & Emergency69.5
Cardiac inpatients46.3
Burns 246.3
Oncology23.2
General surgery23.2
Orthopaedics11.6
High Dependence Unit11.6
Neuro-medical11.6
General medical11.6
Cardiac outpatients11.6
Not recorded813

Within the survey, a large number of differing clinical contexts and therefore clinical teams are represented, which is very encouraging given the participants positive experience.

Demographics: Range of medication used relating to the child or young person's procedural sedation

Base: N = 63

Medication usedN%
Entonox3048%
Midazolam1930%
Oral morphine914%
Chloral hydrate11.6%
IV morphine11.6%
Oral ketamine11.6%
IV ketamine11.6%
Not recorded1118

Decisions made by the GDG when reviewing the initial scope and resulting clinical questions helped focus the pharmacological interventions review to what agents were in common use. The survey results reflect those discussions in that all of the above agents were systemically reviewed, with oral morphine being reviewed when used in combination. The single use of oral morphine is not advised. Propofol as a single agent it was not used at all in this large NHS Foundation Trust.

Demographics: Range of clinical procedure chosen in relation to the child or young person's procedural sedation

Base: N = 63

ProcedureN%
Change of wound dressings1422
Urodynamics711
Intra-articular steroid injections610
Other610
Cannulation46.3
Removal of chest drains46.3
Gamma camera34.8
Botox injections23.2
Removal of sutures23.2
Removal of wound drains23.2
MRI11.6
Lumbar puncture11.6
Removal of wires11.6
Catheter insertion11.6
Changing of line position11.6
Not recorded813

The survey results are also helpful regarding the types of procedure anticipated in relation to the target guideline population. The one clear obvious omission is dental treatment, which the survey was not able to include.

The survey results within the context of the clinically important issues are extremely useful as they, for the most part, affirm the clinical interpretation of the evidence by the GDG in relation to targeting key clinical contexts, key clinical procedures and key clinical interventions. That said, the way children and young people are supported through the sedation experience is of perhaps the greatest interest.

The experience of children and young people undergoing procedural sedation:Part 1: Information and support.

The experience of children and young people undergoing procedural sedation:
Part 1: Information and support

Base: N = 63

The GDG subgroup had carefully considered the type of questions we wanted to ask; these covered the pre-procedural phase when the child or young person is being prepared (information, consent, visualisation), during procedure (amnesic effect, pain free) and the post procedural phase (amnesic effect, nausea, emotional response, preparedness for repeat intervention under sedation).

The questions were then in discussion with Priority Research who have experience in conducting this type of survey finalised to ensure they would be understood by all age ranges and that they would readily translate into the range of languages used.

The experience of children and young people undergoing procedural sedation:Part 2: Emotional engagement and memory recall.

The experience of children and young people undergoing procedural sedation:
Part 2: Emotional engagement and memory recall

Base: N = 63

The survey results are particularly interesting in this area as they indicate that children and young people have an extremely positive experience of sedation in relation to a wide range and variety of clinical procedures and clinical settings. The responses indicate little variation in practice in this one NHS Foundation Trust, and are indicative of the benefit that clinical guidance can bring when clinical and patient pathways are followed to plan and prepare the patient and ensure their experience is positive.

The results are seen as indicating that much of this is bearing this positive outcome.

The experience of children and young people undergoing procedural sedation:
Part 1 and 2 survey detail in relation to responses and percentage breakdown

Base: N = 63

PercentagesFurther details
Disagree a lotDisagree a bitIn the middleAgree a bitAgree a lotBaseN/R%ResponseTotal base
I was told everything I wanted to know about what would happen003.51284576.69363
I was told enough about the sedation1.81.81.81184559.89063
I was told enough about how I might feel01.89.13.685559.89063
I was taught things I could do to help me feel OK with what would happen6610166250188263
I had time to ask any questions I wanted3.63.61.81379568.29263
The people looking after me were nice to me and helped me feel OK01.803.695568.29263
PercentagesFurther details
As much as I can imagineLoadsQuite a lotSomeJust a little bitNot at allBaseN/R%ResponseTotal base
How upset did you feel afterwards?03.65.55.5246255138763
How scared did you feel after you had the sedation medicine?1.91.95.611176354148663
Thinking about what happened after you had the sedation medicine, how much did it hurt?03.81115284253168463
How scared did you feel before you were given the sedation medicine?111.81318203655138763
The experience of children and young people undergoing procedural sedation:Part 3 Outcomes.

The experience of children and young people undergoing procedural sedation:
Part 3 Outcomes

Amnesic effect of sedation in relation to memory of procedure

Did you feel sick after the procedure?

Did you feel sick after the procedure?

Would you want sedation again if you had to have more treatment?

Would you want sedation again if you had to have more treatment?

The above outcomes were related to other variables. As would be expected, the degree of amnesia was dependent on the agent used; 13 of the 16 respondents who said they remembered “everything” had received Entonox, whilst of the 13 who received the benzodiazepine, five remembered “nothing” and five “just a little bit”.

Post procedural nausea was related only to the degree of upset felt afterwards; those who felt more upset were more likely to report nausea (p = 0.019) but the direction of causality is not clear.

Only four patients said that they would not want to receive sedation again if undergoing the same procedure; this was significantly related to only two variables, both ratings of distress during the procedure after sedation. All four reported more than “just a little” pain during the procedure (p = 0.006) and being more than “just a little bit” scared (p = 0.001).

7.7. Conclusions

The survey results within the context of the clinically important issues are extremely useful as they by large, affirm the clinical interpretation of the evidence by the GDG in relation to targeting key clinical contexts, key clinical procedures, key clinical interventions. That said, the way children and young people are supported through the sedation experience is of perhaps the greatest interest.

The survey provided the GDG with an immediate contextual opportunity to test areas of importance in relation to all aspects of the scope, and in particular areas relating to the preparation and experience of the child or young person receiving sedation. Survey findings supported the shaping of clinical questions relating to pharmacological interventions reviews and what agents were in commonly used, allowing for these to be systematically reviewed in single or combination therapies. The absence of propofol as a single agent is noted that it was not used at all in this large NHS Foundation Trust. Propofol is reported in the evidence to recommendations as having a wide margin of safety, requiring additional training as deep sedation may result despite a different target level of sedation being aimed for.

The guideline provides the basis to see this aspect of sedation practice change. The survey provided contextual evidence that supports the outcomes of the narrative review relating to psychological support. During the pre procedural phase when the child or young person is being prepared, clear information, informed consent and the use of visualisation in preparation were highlighted as areas that are important in determining a positive experience with successful outcome. The results of the survey relating to the amnesic effect and pain management affect are less strong, but support consistently the findings of evidence reviews (particular pain management) and undoubtedly helped the GDG shape recommendations with greater confidence.

The higher level questions of satisfaction relating to the child or young person's experience are very strong indicating when undergoing sedation, an extremely positive experience is reported in relation to a wide range and variety of clinical procedures and clinical settings (dental care is not part of the survey population). Responses indicate little variation in practice in one NHS Foundation Trust, and are indicative of the benefit that the clinical guideline will have in shaping clinical and patient pathways as part of the implementation strategy.

Copyright © 2010, National Clinical Guideline Centre.

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Cover of Sedation in Children and Young People
Sedation in Children and Young People: Sedation for Diagnostic and Therapeutic Procedures in Children and Young People [Internet].
NICE Clinical Guidelines, No. 112.
National Clinical Guideline Centre (UK).

NICE (National Institute for Health and Care Excellence)

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