Retsudvalget 2020-21
B 7 Bilag 6
Offentligt
2302475_0001.png
Til Styrelsen for Patientsikkerhed
d26/11 2019
DASAIM
Dansk Selskab
for Anæstesiologi
og Intensiv Medicin
Uddybelse af DASAIMs høringssvar d 18/9 2018 vedrørende omskæring af drenge.
Dansk Selskab for Anæstesiologi og Intensiv Medicin vil indledningsvis gerne takke for mulighe-
den for at uddybe vores høringssvar samt for mulighed for deltagelse i arbejdsgruppen vedrøren-
de drengeomskæring.
Omskæring af drengebørn på lægelig indikation i forbindelse med sygdomme udføres udelukken-
de i generel anæstesi i det danske sundhedsvæsen.
Generel anæstesi til børn kan foregå på sikker vis når de rette kompetencer og det rette udstyr er
tilstede, på det rette sted.
DASAIM tilslutter sig Safetots.org initiativet, (https://www.safetots.org) som blandt andet på bag-
grund af anerkendelse af FN´s børnekonvention (UNCRC) og EACH charteret (1988) anbefaler,
børne-kompetent anæstesiolog til alle børn under 3 år.. Safetots.org initiativet understøttes af eu-
ropæiske og internationale anæstesiologiske selskaber (European Society for Paediatric Anae-
sthesiology (ESPA), Association Des Anesthésistes-Réanimateurs Pédiatriques d’Expression
Française, Società di Anestesia e Rianimazione Neonatale Pediatrica Italiana, Asociación de
Anestesia, Analgesia y Reanimación de Buenos Aires).
Litteraturen beskriver forskellige former for lokalbedøvelse til omskæring af drenge, men ingen af
disse giver fuldstændig smertefrihed: Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal
circumsicion. Cochrane review 2004).
Forfatteren konkluderer at ingen af de anvendte former for lokalbedøvelse giver fuldstændig
smertefrihed under omskæring.
DASAIM finder det under faglig standard at udføre en smertefuld kirurgisk procedure på børn
uden sufficient smertedække.
Uanset indikation (medicinsk eller rituel) har DASAIM den holdning, at alle børn har krav på sikker
kirurgi under fuldstændig smertefrihed. Dette kan ifølge DASAIM kun foregå i en kombination af
generel og regional anæstesi.
Vi har både i Danmark og i vores nabolande set tilfælde af livstruende komplikationer i forbindelse
med lokalanæstetiske midler. Både i form af methæmoglobinæmi ved prilocain samt systemisk
toxicitet af lokalanæstetika. Komplikationerne inkluderer kredsløbssvigt, bevidstløshed og kram-
per samt iltmangel.
Vi skal i den forbindelse opfordre til at Styrelsen for Patientsikkerhed i forbindelse med tilsyn på-
ser at følgende er opfyldt:
DASAIM – sekretariat v/ Tina Calundann
c/o AN-OP, HOC 4231, Rigshospitalet, Blegdamsvej 9, 2100 København Ø
tlf. 3545 6602 - e-mail: [email protected]
B 7 - 2020-21 - Bilag 6: Henvendelse af 28/11-20 fra DASAIM, vedrørende høringssvar om Styrelsen for Patientsikkerheds vejledning om ikke-terapeutisk omskæring af drenge
Mundtlig og skriftlig information af forældre om plan for smertebehandling.
Mundtlig og skriftlig information af forældre om observation af bivirkninger til smertebe-
handlingen.
Tilstedeværelser af læge med kompetencer i behandling af børn med komplikationer til
smertebehandling. Herunder kompetencer i behandling af kramper og kredsløbssvigt.
Styrelsen spørger ind til 2 forhold, som er følger af utilstrækkelig analgesi ved omskæring af små
børn:
1. Følger af utilstrækkelig analgesi. (Hvis barnet ikke er tilstrækkelig anæsteseret og smerte-
lindret i forbindelse med det kirurgiske indgreb må man antage at barnet er blevet ufrivilligt
fastholdt af voksne personer under indgrebet)
2. Følger af fastholdelse af børn.
Ad. 1. Følger på sigt af ubehandlet smerte hos nyfødte. Se bilag 1.
DASAIM forholder sig til at der er human og dyreeksperimentel forskning som tyder på skadelige
langtidsfølger af ubehandlet smerte hos nyfødte børn/forsøgsdyr.
Ad. 2. Følger af ufrivillig fastholdelse. Se bilag 2.
DASAIM forholder sig til at ufrivillig fastholdelse må formodes at finde sted ved mangelfuld anal-
gesi under omskæring af drenge. DASAIM bekendt er dette ikke undersøgt hos nyfødte. Der fore-
ligger dog en del pædiatrisk litteratur, som dokumenterer skadelige følger af ufrivillig fastholdelse
hos børn.
Effect of Restraint Use on Family. Se bilag 3.
DASAIM forholder sig til at der foreligger forskning, som dokumenterer skadelige følger for børn
som følge af ufrivillig fastholdelse i forbindelse med medicinske procedurer og kirurgiske operati-
oner. Desuden kan fastholdelse have konsekvenser for forholdet mellem barn og forældre.
Konklusion
Planlagt kirurgi uden de ovenfor nævnte anbefalinger anses af DASAIM for at være væsentligt
under faglig standard. DASAIM vil anbefale Styrelsen for Patientsikkerhed at være opmærksom
på ovennævnte forbehold når Styrelsen udfører tilsyn på klinikker og hospitaler. Læger der udfø-
rer planlagt kirurgi på utilstrækkeligt bedøvede børn bør undergå et fagligt tilsyn. Såfremt der ikke
omgående rettes op og sikres moderne og sufficient behandling af denne patient gruppe bør der
gennemføres virksomhedsindskrænkning og eventuelt permanent autorisationsfratagelse.
Når den færdige rapport foreligger, forventer vi at have haft mulighed for at godkende den faglige
rådgivning vi eventuelt tages til indtægt for. Såfremt vores råd ikke følges, har vi fortsat et stort
ønske om at vores faglige rådgivning som minimum fremgår af et bilag.
DASAIM – sekretariat v/ Tina Calundann
c/o AN-OP, HOC 4231, Rigshospitalet, Blegdamsvej 9, 2100 København Ø
tlf. 3545 6602 - e-mail: [email protected]
B 7 - 2020-21 - Bilag 6: Henvendelse af 28/11-20 fra DASAIM, vedrørende høringssvar om Styrelsen for Patientsikkerheds vejledning om ikke-terapeutisk omskæring af drenge
Bilag 1:
Fra: Maria Fitzgerald.
THE DEVELOPMENT OF NOCICEPTIVE CIRCUITS. Review. NATURE
REVIEWS | NEUROSCIENCE VOLUME 6 | JULY 2005.
“Increasing awareness of activity dependent and injury-related plasticity in the newborn CNS has
highlighted the possibility that early tissue injury can affect future pain processing through devel-
opmental alterations in nociceptive circuitry” (Grunau, R. Early pain in preterm infants. A model of
long-term effects.
Clin. Perinatol.
29, 373–394;(2002).
“Many preterm infants receive numerous invasive procedures in intensive care and it is not al-
ways possible to achieve adequate levels of analgesia. There is evidence from both animal mod-
els and humans that these early pain experiences might alter subsequent CNS function” (Grunau,
R. Early pain in preterm infants. A model of long-term effects.
Clin. Perinatol.
29, 373–394;
(2002). Anand, K. J. Pain, plasticity, and premature birth: a prescription for permanent suffering?
Nature Med.
6,971–973 (2000). Peters, J. W.
et al.
Does neonatal surgery lead to increased pain
sensitivity in later childhood?
Pain
114, 444–454 (2005)).
“Although many of the nervous system responses to local tissue damage resolve after the injury
has healed, tissue damage during a critical period in newborn rodents can cause prolonged alter-
ations in somatosensory function, which last into adult life. The consequences of neonatal injury
in rodents depend on the type of injury and the modality of sensation under investigation. Repeti-
tive paw needle prick in the first postnatal week produces heat hyperalgesia several weeks later”
(Anand, K. J., Coskun, V., Thrivikraman, K. V., Nemeroff, C. B. & Plotsky, P. M. Long-term behav-
ioral effects of repetitive pain in neonatal rat pups.
Physiol.Behav.
66,
627–637 (1999). Johnston,
C. C. & Walker, C. D. The effects of exposure to repeated minor pain during the neonatal period
on formalin pain behaviour and thermal withdrawal latencies.
Pain Res. Manag.
8,
213–217
(2003).)
“Neonatal hindpaw inflammation has a pronounced effect on the behavioural and dorsal horn cel-
lular response to a second inflammatory challenge well into adulthood” (Ren, K.
et al.
Characteri-
zation of basal and re-inflammation-associated long-term alteration in pain responsivity following
short-lasting neonatal local inflammatory insult.
Pain
110, 588–596 (2004). Ruda, M. A., Ling, Q.
D., Hohmann, A. G., Peng, Y. B. & Tachibana, T. Altered nociceptive neuronal circuits after neo-
natal peripheral inflammation.
Science
289, 628–631 (2000). Tachibana, T., Ling, Q. D. & Ruda,
M. A. Increased Fos induction in adult rats that experienced neonatal peripheral inflammation.
Neuroreport
12, 925–927 (2001).
“Chemical or mechanical irritation of the colon in P8–21 rats, on the other hand, produces a per-
sistent visceral hypersensitivity in the adult” (Al Chaer, E. D., Kawasaki, M. & Pasricha, P. J. A
new model of chronic visceral hypersensitivity in adult rats induced by colon irritation during post-
natal development.
Gastroenterology
119, 1276–1285 (2000).
“Skin wounds in the newborn also have prolonged effects: the skin remains hypersensitive long
after the wound has healed” (Reynolds, M. L. & Fitzgerald, M. Long-term sensory hyperinnerva-
tion following neonatal skin wounds.
J. Comp. Neurol.
358, 487–498 (1995).)
“The size of the dorsal horn receptive field increases for at least six weeks following injury”
(Torsney, C. & Fitzgerald, M. Spinal dorsal horn cell receptive field size is increased in adult rats
following neonatal hindpaw skin injury.
J. Physiol. (Lond.)
550, 255–261 (2003).
“A clear-cut example of a central adaptive response to neonatal injury is seen following peripheral
nervedamage. Although partial peripheral nerve damage in adult rodents causes significant and
prolonged neuropathic pain behavior, which is characterized by marked allodynia, this does not
occur in rat pups up to the age of P21.” (Howard, R. F., Walker, S. M., Mota, M. & Fitzgerald, M.
The ontogeny of neuropathic pain: postnatal onset of mechanical allodynia in rat spared nerve in-
jury (SNI) and chronic constriction injury (CCI) models.
Pain
115, 382–389 (2005).)
DASAIM – sekretariat v/ Tina Calundann
c/o AN-OP, HOC 4231, Rigshospitalet, Blegdamsvej 9, 2100 København Ø
tlf. 3545 6602 - e-mail: [email protected]
B 7 - 2020-21 - Bilag 6: Henvendelse af 28/11-20 fra DASAIM, vedrørende høringssvar om Styrelsen for Patientsikkerheds vejledning om ikke-terapeutisk omskæring af drenge
Endelig er der en del litteratur om følger af procedure-relateret smerte hos børn:
Wintgens A, Boileau B, Robaey P. Posttraumatic stress symptoms and medical procedures in
children. Can J Psychiatry 1997; 42:611–616.
Taddio A, Shah V, Gilbert-MacLeod C, Katz J. Conditioning and hyperalgesia in newborns ex-
posed to repeated heel lances. JAMA 2002; 288:857–861.
Weisman SJ, Bernstein B, Schechter NL. Consequences of inadequate analgesia during painful
procedures in children. Arch Pediatr Adolesc Med 1998; 152:147–149.
Bienvenu OJ, Eaton WW. The epidemiology of blood-injection-injury phobia. Psychol Med 1998;
28:1129–1136.
Caes L, Goubert L, Devos P, et al. The relationship between parental catastrophizing about child
pain and distress in response to medical procedures in the context of childhood cancer treatment:
a longitudinal analysis. J Pediatr Psychol 2014; 39:677–686.
Brodzinski H, Iyer S. Behavior changes after minor emergency procedures. Pediatr Emerg Care
2013; 29:1098–1101.
Power NM, Howard RF, Wade AM, Franck LS. Pain and behaviour changes in children following
surgery. Arch Dis Child 2012; 97:879–884.
Beaton L, Freeman R, Humphris G. Why are people afraid of the dentist? Observations and ex-
planations. Med Princ Pract 2014; 23:295–301.
Taddio A, IppM, Thivakaran S, et al. Survey of the prevalence of immunization noncompliance
due to needle fears in children and adults. Vaccine 2012; 30:4807–4812.
McMurtry CM, Pillai Riddell R, Taddio A, et al. Far from ‘just a poke’: common painful needle pro-
cedures and the development of needle fear. Clin J Pain 2015; 31 (10 Suppl): S3–S11.
DASAIM – sekretariat v/ Tina Calundann
c/o AN-OP, HOC 4231, Rigshospitalet, Blegdamsvej 9, 2100 København Ø
tlf. 3545 6602 - e-mail: [email protected]
B 7 - 2020-21 - Bilag 6: Henvendelse af 28/11-20 fra DASAIM, vedrørende høringssvar om Styrelsen for Patientsikkerheds vejledning om ikke-terapeutisk omskæring af drenge
Bilag 2:
“Restraint (in terms of the effects it has) has been associated with speech and language prob-
lems, a negative self-image, fear of and distrust of medical care, and with post-traumatic stress
disorder”. (Brenner M. ‘Child restraint in the acute setting of pediatric nursing: an extraordinarily
stressful event’.
Issues in comprehensive pediatric nursing.
2007;30(1–2): 29–37.)
“According to pediatric nurses, restraint is more traumatic for a child than the treatment itself”
(Robinson S, Collier J. ‘Holding children still for procedures”.
Paediatric nursing.
1997;9(4): 12–
14.)
“Longitudinal research with leukemia patients has shown that any participation by parents in re-
straint has a negative effect on the relationship with their child”. McGrath P, Forrester K, Fox-
Young S, Huff N. ‘“Holding the child down” for treatment in paediatric haematology: the ethical,
legal and practice implications.
Journal of law and medicine.
2002;10(1): 84–96.
Effect of Restraint Use on Children (Piet Leroy).
“The use of restraint with children is not beneficial and also is extraordinarily stressful” (Masters,
1998; Mohr WK, Mahon MM, Noone MJ. A restraint on restraints: the need to reconsider the use
of restrictive interventions. Arch Psychiatr Nurs. 1998 Apr;12(2):95-106. Mar-
tinez RJ, Grimm M, Adamson MJ. From the other side of the door: patient views of seclusion.
Psychosoc Nurs Ment Health Serv. 1999 Mar;37(3):13-22.).
“This is supported by discourse that suggests that children find the experience of being restrained
much more distressing than the pain involved in the treatment or procedure that prompted the use
of restraint.” (Collier J, Pattison H. Paediatr Nurs. Attitudes to children's pain: exploding the 'pain
myth'. 1997, Dec;9(10):15-8; Folkes KIs restraint a form of abuse?
.
Paediatr
Nurs. 2005 Jul;17(6):41-4.).
“Although few data are available, some authors have hypothesized about the long-term conse-
quences of restraint on hospitalized children. For example, Siblinga and Friedman (1971) sug-
gested that language deficits and delayed speech may occur as a result of restraint use, while
others hypothesized that a relationship existed between use of restraint, loss of motor strength,
and negative body image”. (Dowd EL, Novak JC, Ray EJ. Releasing the hospitalized child from
restraints.MCN Am J Matern Child Nurs. 1977 Nov-Dec;2(6):370-3.).
“Twenty years later, Selekman and Snyder proposed that psychological problems such as future
fears and impact on trusting relationships also may be issues of concern related to the use of re-
strain” (AACN Clin Issues. 1996 Nov;7(4):603-10.) Uses of and alternatives to restraints in pediat-
ric settings).
“They also hypothesized about a link between increased stress and the disease process. Other
authors have suggested that restraint of children may lead to cumulative retraumatization and
post-traumatic stress disorder (PTSD), physical discomfort, unexpected death, and asphyxia”
(Masters, 1998; Kennedy SS, Mohr WK. Am J Ortho-psychiatry. 2001 Jan;71(1):26-37. A prole-
gomenon on restraint of children: implicating constitutional rights.).
DASAIM – sekretariat v/ Tina Calundann
c/o AN-OP, HOC 4231, Rigshospitalet, Blegdamsvej 9, 2100 København Ø
tlf. 3545 6602 - e-mail: [email protected]
B 7 - 2020-21 - Bilag 6: Henvendelse af 28/11-20 fra DASAIM, vedrørende høringssvar om Styrelsen for Patientsikkerheds vejledning om ikke-terapeutisk omskæring af drenge
Bilag 3.
“At a time when family-centered care is advocated and encouraged, examination of the outcomes
of child restraint on parents has been neglected.” (McGrath P, Huff N. Aust J Holist
Nurs. 2003 Oct;10(2):5-10. Including the fathers' perspective in holistic care. Part 2: Findings on
the fathers' hospital experience including restraining the child patient for treatment.; Moscardi-
no U, Axia G. Infants' responses to arm restraint at 2 and 6 months: a longitudinal study.Infant
Behav Dev. 2006 Jan;29(1):59-69.).
“Fathers’ experience of restraining their children for oncology treatment was explored by McGrath
and Huff (2003). The investigators reported that witnessing and being involved in invasive proce-
dures was the most challenging and emotionally traumatic aspect of hospitalization for fathers.
The study concluded that not all parents were happy to, or should be coerced into, assisting staff
to hold their children during a procedure. Parental distress also was a theme that emerged from a
more recent study related to child restraint “ (Moscardino U, Axia G.Infant Behav
Dev. 2006 Jan;29(1):59-69. Infants' responses to arm restraint at 2 and 6 months: a longitudinal
study.), whose purpose it was to confirm theories of child development by examining infant re-
sponse to restraint. Fifty-two infants were examined at two months and six months of age to de-
termine differences in infant response to restraint during the four-month period. However, 33 per-
cent of the infants did not complete the study, as involvement was too distressing for the infants
and their parents. This report highlights some of the distress surrounding the use of restraints.”
“Although many authors suggest alternatives to restraint, there is scant research in this area. In
child psychiatry, there is no mention of anticipatory interventions, and practice parameters of the
American Academy of Child and Adolescent Psychiatry (AACAP) offer only vague guidance to
forestall aggressive behavior in children (AACAP, 2000). However, it is noted that the AACAP
works continuously with parents, former child psychiatry patients, and staff to review its recom-
mendations in relation to restraint. The literature suggests that a variety of alternatives, such as
distraction, play therapists, the use of parents, improved pain relief, and behavioral interventions,
could lead to less restraint in practice (McCarthy, Cool, & Hanrahan, 1998; Dorfman, 2000; Mar-
tin, 2002; McGrath and Huff, 2003; Meunier-Sham & Ryan, 2003; Tomlinson, 2004; Willock, 2004;
Piira, Sugiura, Champion, Donnelly, & Cole 2005). Although other publications provide practical
decision-making frameworks and clinical practice benchmarks to guide nurses towards the most
appropriate strategy when immobilization may be required (Bland, Bridge, Cooper, Dixon, Hay, &
Zerbato 2002; Jeffrey, 2002; Lambrenos & McArthur, 2003; Folkes, 2005), there is a dearth of
empirical data that comprehensively explores alternatives to the use of restraint in children.
Folkes (2005) developed a decision-making algorithm that highlights the importance of the child’s
assent and/or consent, staff explanations, and use of alternatives to restraint. This tool also offers
a pathway in an emergency situation whereby restraint may be required. The final part of the al-
gorithm highlights the importance and necessity of documentation. Documentation also is the key
focus of an article by Jeffrey (2002), who offers a broader framework for nurses considering the
use of restraint. According to Jeffrey (2002), the key to decision-making and restraint is reliant on
two areas: thorough assessment of the child’s current needs and appraisal of documentation re-
garding the results of any previous immobilization or restraint of the child.
DASAIM – sekretariat v/ Tina Calundann
c/o AN-OP, HOC 4231, Rigshospitalet, Blegdamsvej 9, 2100 København Ø
tlf. 3545 6602 - e-mail: [email protected]