PARTICIPANTS AND METHODS

The study was approved by the Ethics Committee of Kuopio University Hospital and was conducted in accordance with the latest revision of the Declaration of Helsinki. The National Agency for Medicines (Helsinki, Finland) was notified of the use of ketoprofen in children younger than 12 years. Both the parents and children old enough were informed, and written consent was obtained. This report is a part of a larger trial, and some other results of which have already been published. Our study comprised 300 consecutive children (179 boys and 121 girls) aged 1 to 10 years ( mean age, 3.8 years), American Society of Anesthesiologists’ physical status 1,undergoing day-case adenoidectomy during 1999 through 2000 in the Ambu-latory Care Unit of Kuopio University Hospital. Patients were excluded if they had a known allergy to ketoprofen or other nonsteroidal anti-inflammatory drugs, asthma, hemorrhagic diathesis, kidney or liver dysfunction, or had any other known contraindication for nonsteroidal antiinflammatory drugs.

During the hospital stay, none of the children had any signs of an acute respiratory infection.

In the hospital, the trial, as a whole, was conducted in 3 stages differing in the administration routes of ketoprofen. Previously published parts of the study were prospective, randomized, double-blind, and double-dummy with a placebo control. In the present study, a total of 213 children received the first dose of ketoprofen before surgery and 87 children at discharge.

A similar endotracheal anesthesia was used for all children. Eutectic mixture of local anesthetics (EMLA) cream (Astra, So¨derta¨lje, Sweden) was used at the venous puncture site. Each child was premedicated with diazepam, 1 µg/kg of fentanyl citrate was given intravenously, and anesthesia was induced with thiopental sodium, intravenously. To facilitate tracheal intubation, cisatracurium besylate was given intravenously. Anesthesia was maintained with sevoflurane in nitrous oxide in oxygen with intermittent positive pressure ventilation. On completion of the procedure, muscle relaxation was reversed with administration of neostigmine bromide and glycopyrrolate.

The adenoids were removed using a curettage technique under visual control. Hemostasis was controlled with temporary nasopharyngeal packs and suction electrocautery, if needed.

After the operation, children were transferred to the postanesthesia care unit for continuous monitoring of vital signs and assessment of pain. In the postanesthesia care unit, if the child was in pain (a pain score at rest $3, on a 0-10 pain scale) fentanyl was given for rescue analgesia. No other analgesic medication was used during the 3-hour stay in the postanesthesia care unit.

Patients were discharged when they were awake, able to walk unaided, had stable vital signs for at least 1 hour, had no pain or only mild pain, had not vomited for 1 hour, were able to tolerate clear fluid by mouth, and had no bleeding. At discharge, all children were given 1 mg/kg of ketoprofen, intravenously.

At discharge, parents were instructed about the postoperative care of their child and pain management at home. A proactive pain treatment protocol was used at home with 5 mg/kg of ketoprofen per day, divided into 2 or 3 doses as tablets or suppositories. Medication was obtained by parents at dis-charge; parents were enforced to give the children ketoprofen on a regular basis for at least 72 hours after surgery and thereafter if needed. Parents were also given hospital contact telephone numbers in case of problems at home. All verbal information was reinforced with written instructions.

To evaluate the changes in the child’s postoperative behavior, the caregivers completed a questionnaire containing 24 items adapted from the Posthospital Behavioral Questionnaire modified by Kotiniemi et al. Data concerning the behavioral changes at home were collected at 3 consecutive times: on the day of operation before surgery, 1 week after the surgery, and 3 weeks after the surgery(Figure1). The first questionnaire was a retrospective evaluation of children’s behavior for a 1-month period before the operation. It also contained baseline data regarding demographics (eg, age, sex, weight, and height), disease status, family status, and family disease status.

The items in the 3 questionnaires were divided into 4 domains: emotional distress, physical symptoms, daytime function disturbances, and sleep disturbances. In each of the 3 questionnaires, the caregivers rated the items on a 4-point scale (1=never, 2=occasionally, 3=weekly, or 4=daily). In the second and third questionnaires, parents were asked to compare each item with those for the previous data collection date (1=much less, 2=slightly less, 3=the same, 4=slightly more, or 5=much more). Thus, a higher score indicated a poorer outcome in both scales.

The baseline score for the 4 domains was calculated as a mean of the item scores, and the follow-up scores were similarly determined for the latter 2 questionnaires. Thus, a change score was calculated by subtracting the follow-up score from the score obtained at baseline (negative values reflect improved behavioral changes).

The second questionnaire, 1 week after surgery, consisted of questions about the intensity and duration of the pain experienced by the child at home, and about medication requirements and any adverseevents. At home, pain intensity was assessed using a 4-point verbal rating scale(1=no pain,2=mild pain, 3=moderate pain, or 4=severe pain).

A reminder letter was sent if either of the 2 latter questionnaires had not been returned in 6 weeks.

All statistical analyses were made using a statistical program (SPSS9.0;SPSSInc, Chicago,Ill). Change scores after surgery (1 week and 3 weeks) for each domain were compared with the scores obtained at baseline using repeated-measures analysis of variance. The internal consistency of the survey was assessed to determine reliability. The calculation of Cronbach a was used for the instrument as a whole and with removal of each domain. The reliability coefficient a greater than .70 was considered to be evidence of good reliability. The measure of agreement between 2 different rating methods was used to measure the change in postoperative behavior consecutively after 1 week and 3 weeks. Each domain was assessed by the Spear-man rank correlation test and the k test. A P value of less than .05 was considered to be statistically significant.

Results are presented as number (percentage) of cases, or mean (SD or range), as appropriate.