Many children feel agitated, are upset and cry when they wake up from anaesthesia and surgery; it is like trying to wake them up from a bad dream. Agitation is a well-known phenomenon in the recovery room, and naturally focus is on alleviating the phenomenon when it occurs. Staff often try to relieve the symptoms as soon as they arise.
But now there is good news for children, parents and staff in the recovery room:
Agitation can be prevented during surgery itself with a single dose of medicine.
In a new study, a team of researchers from the Department of Anaesthesiology - Juliane Marie Centre has documented that a dose of 3 μg/kg of clonidine during the final stage of surgery can significantly reduce postoperative agitation in children and young adults.
The study is the largest of its kind in the world within this field, and was conducted collaboratively with the Copenhagen Trial Unit. Three paediatric anaesthesia and surgery departments in Denmark were involved in the study; Rigshospitalet, Zealand University Hospital in Køge, and Vejle Hospital.
The 379 children aged between one and five years who participated in the study were otherwise healthy and underwent surgery on an outpatient basis for hernia, undescended testes or tonsillectomy.
Half of the children were randomised into receiving 3 μg/kg clonidine around 20 minutes before the end of surgery, whereas the control group received a placebo treatment. The results were significant. The children who received clonidine had more than a 40% lower risk of agitation and were generally more calm, had less pain and required less pain relief than the children in the control group. The majority of the children in the study were boys. Therefore, the researchers can only draw conclusions on the effect in boys and not in girls.
The researchers and the physicians and nurses involved in the recovery measured the children's agitation at predefined times, for example, every 15 minutes after surgery on a validated "agitation scale" (the Watcha scale).
The effect of the medicine was also measured in other ways: For example, the researchers measured how much pain-relieving medicine the children were given, and how often they experienced nausea and vomiting. The medicine proved effective in all parameters.
Major impact – also in the long term
"This research result can make a huge difference for children and young adults undergoing surgery - and not least for their parents," said Arash Afshari, Head of Research at the Department of Anaesthesiology - Juliane Marie Centre. Postoperative agitation and pain in children affect the children, their parents and the staff taking care of them," he said.
Other studies have shown that reducing the occurrence of agitation, also reduces other side effects of surgery, for example, bed-wetting, sleeping problems, sleep disturbance or fear of going to hospital again.
The researchers monitored the children for 30 days following the surgery to see whether there were any unexpected side effects, but there were no indications of these in the results.
Recommendations for paediatric surgery throughout the world
"Not many studies of this kind have followed children for 30 days, so we’re fairly convinced that this is a safe way to prevent postoperative agitation in children," said Mogens Ydemann, Anaesthesiologist and first author of the article on the study recently published in the Lancet, Child and Adolescent Health.
On the basis of the size, scope and thoroughness of the study, the authors now clearly recommend all surgery wards throughout the world operating on children and young adults and using anaesthetic gases to:
Give children 3 μg/kg of intravenous clonidine around 20 minutes before the end of surgery, unless contraindicated.
The method is useful for surgery lasting longer than 15-20 minutes as clonidine is only effective after around 10-15 minutes. The procedure requires that the child has an IV line, which is common for the slightly larger operations and for children who have had bad experience with anaesthesia or surgery. Therefore, clonidine is particularly relevant for this type of patient.
Clonidine is a drug approved to treat women with hot flushes during menopause, to prevent migraine and to treat high blood pressure. In addition, clonidine is used off-label to treat acute pain, calm children in intensive-care departments and to prevent postanaesthetic / postoperative agitation in children.
Clonidine has not previously been routinely used to prevent postanaesthetic / postoperative agitation.
Less pain and nausea
The study also shows that clonidine has an effect on the use of pain-relieving medicine.
The children who were given clonidine had considerably less need for strong pain relief in recovery and only required pain relief after 105 minutes, whereas the control group who were given placebo needed pain relief after 60 minutes. Moreover, fewer children in the clonidine group experienced nausea or vomiting.
"The only disadvantage seems to be that the children have to stay a little longer in recovery if they are given clonidine. We believe that this is a price worth paying as there’s usually no shortage of space in this ward. It could be interesting to examine the effect more closely in the types of paediatric surgery not included in the study, and examine in particular the influence of gender on the treatment, i.e. whether there is a difference between girls and boys in this respect," explained Arash Afshari.
In the process of being implemented
Rigshospitalet is currently spreading the news about the advantages of clonidine to all surgery wards, and clonidine is already being used much more than previously. The drug is quite cheap, and Arash Afshari is convinced that, in the near future, it will become a routine procedure in all major surgery on children.