Correlation Between Pain and Emergence Delirium After Adenotonsillectomy in Preschool Children (e-PONB ENT)
|ClinicalTrials.gov Identifier: NCT01096797|
Recruitment Status : Completed
First Posted : March 31, 2010
Last Update Posted : March 31, 2010
|Condition or disease||Intervention/treatment||Phase|
|Adenotonsillectomy Postoperative Pain Emergence Delirium||Drug: Sevoflurane||Phase 4|
Tonsillectomy and/or adenoidectomy is the most common surgery performed in paediatric population. Sevoflurane is the most frequently volatile anaesthetic used in paediatric population. It is well tolerated, allows rapid anaesthesia induction, faster emergence, orientation. A child who emerges from sevoflurane anaesthesia may experience a variety of behavioural disturbances described as "emergence delirium" (ED).
ED has been described as "a mental disturbance during the recovery from general anaesthesia consisting of hallucinations, delusions and confusion manifested by moaning, restlessness, involuntary physical activity, and thrashing about in bed" in the immediate post anaesthesia period. Additionally paranoid ideation has been observed in combination with these emergence behaviours.
Restless recovery from anaesthesia is an important problem. It may lead, along with injury to the child, bleeding from surgical site, to accidental removal of IV catheters and drains. Once ED occur, extra nursing care may be necessary, as well as supplemental sedative and/or analgesic medications, which may be associated to respiratory depression or airway obstruction and may delay patient discharge. Although long-term psychological implications of ED remain unknown, children with restless recovery from anaesthesia are seven times more likely to have new-onset separation anxiety, apathy, eating and sleep problems.
ED after sevoflurane anaesthesia has been suggested both to be and not to be associated with postoperative pain behaviour. Accordingly, adequate pain relief has been found to reduce or have no effect on ED after sevoflurane anaesthesia. Because a self-evaluation is difficult In preschool boy observational scales based on behaviour like CHIPPS, FLACC or CHEOPS are used for the measurement of pain.
Given that the child's behaviour evaluation at emergence is made with observational scales, a superimposition between ED and pain measurement is possible. Nurses and doctors using behavioural scales for the evaluation of ED and pain may not be able to differentiate pain from ED during awakening. This may led to the treatment of an autolimitated disturb (ED) or to the under treatment of pain after surgery.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Cohort Study Evaluating Incidence and Correlation Between Pain and Emergence Delirium After Adenotonsillectomy in Preschool Children|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
Experimental: Children undergoing adenotonsillectomy
Children between 2-6 years old undergoing elective adenoidectomy with or without tonsillectomy from the ENT Service of the San Gerardo Hospital.
- Emergence delirium evaluation: Pediatric Anesthesia Emergence Delirium scale (PAED) [ Time Frame: First 15 minutes after awakening. ]Pediatric Anesthesia Emergence Delirium scale(PAED):The PAED scale consists of five psychometric items. To each of them it's possible to assign a score from 0 to 4 (maximum score 20 points). Emergence delirium was defined as a PAED scale score of 10 points of grater.
- Pain: Face, Legs, Activity, Cry, Consolability Scale (FLACCS); Children and Infants Postoperative Pain Scale (CHIPPS); Children Hospital of Eastern Ontario Pain Scale (CHEOPS) [ Time Frame: 15 minutes after awakening ]
- FLACCS: five behavioural items scale with a maximum score of 10 points. Significant pain behaviour correspond to a FLACCS score of 4 points or greater.
- CHIPPS: five behavioural items scale with a maximum score of 10 points. Significant pain behaviour correspond to a FLACCS score of 4 points or greater.
CHEOPS: five behavioural items scale with a maximum score of 13 points. Significant pain behaviour correspond to a CHEOPS score of 7 points or greater
- AgeAge groups: 2 to 4 ys and 5 to 6 ys
- Time of exposure to sevoflurane
- Awakening timeTime between end of sevoflurane exposure and extubation
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01096797
|Department of Perioperative Medicine and Intensive Care. San Gerardo Hospital|
|Monza, MB, Italy, 20052|
|Principal Investigator:||Pablo M Ingelmo, MD||Department of anesthesiology and resuscitation I, San Gerardo Hospital|