Pain, Acute, Pain, Postoperative, Children, Only
Conditions
Keywords
methadone, analgesics, opioids, postoperative, placebo
Brief summary
A prospective double-blind, randomized controlled trial investigating the effect of a single-dose of intraoperative methadone on postoperative pain and opioid consumption in 96 children undergoing open urological surgery.
Detailed description
Treatment of postoperative pain is a challenge in younger children undergoing outpatient surgery. After discharge parents must assess pain intensity and administer analgesics, including opioids, as per needed. It has been shown that parents often hesitate to administer analgesics. The result is unrelieved pain that negatively affects the whole family and increases the risk of unscheduled contacts with healthcare professionals. In children, methadone has shown a half-life of 19,2 +/-13,6 hours. Regarding outpatient surgery, methadone is an opioid with unique pharmalogical properties that may be advantageous. A single-dose of this long acting opioid administered perioperatively could provide a stable analgesia and potentially reduce the need for shorter-acting opioids in the PACU and at home.
Interventions
Single dose, intravenous bolus, 0,1 mg/kg administered at induction of anesthesia.
OTHERPlacebo
Single dose, intravenous bolus. Administered as the experimental arm.
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Randomisation and study medication will be handled by the hospital pharmacy. All research team members, caregiving clinicians and enrolled patients will be blinded to the study allocation arms and the randomisation list will be concealed until all statistical analyses are made.
Intervention model description
Randomized controlled trial.
Eligibility
Sex/Gender
MALE
Age
0 Years to 4 Years
Healthy volunteers
No
Inclusion criteria
Children scheduled for open urological surgery at the Outpatient Clinic at Aarhus University Hospital.
Exclusion criteria
* Age =/\> 5 years at the date of operation * Born preterm (Before gestational age of 37 weeks) * Congenital heart disease * Previous scrotal surgery * Laparoscopic operation * American Society of Anaesthesiologists (ASA) physical status lll, IV or V * Allergy to study drugs * Preoperative daily use of opioids * Parents with inability to provide informed consent * Severe respiratory insufficiency * Acute abdominal pain * Severe kidney insufficiency * Treatment with rifampicin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity (highest score) | 3 hours | FLACC-score - Face, Legs, Activity, Cry og Consolability, 0-10, where 10 is the highest pain score. Within the first 3 hours from extubation (or until discharge from PACU, if discharged before 3 hours) |
| Patients consumption of analgesics in the PACU. | 3 hours | Within the first 3 hours from extubation (or until discharge from PACU, if discharged before 3 hours). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients need of supplemental oxygen in PACU | 3 hours | Need of supplemental oxygen within the first 3 hours after extubation,(or until discharge from PACU, if discharged before 3 hours) |
| Awakenings during the first night after discharge. | 24 hours | Parents will answer whether the child have been awake and whether they believe the awakening(s) where due to pain. |
| Analgesic consumption following discharge until evening on the first postoperative day | 36 hours | From discharge until 8 PM the first day following surgery. Collected by parents. |
| Unscheduled parental contacts to the hospital | 4 days | Parental contacts to hospital regarding pain and/or analgesics until 4 days following surgery. |
| Pain intensity the first postoperative day | 48 hours | Assessed by parents, 3 FLACC-scores - Face, Legs, Activity, Cry og Consolability, 0-10, where 10 is the highest pain score, during the first postoperative day. |
| Readiness to discharge | 6 hours | Time for readiness to discharge from PACU assessed by PACU nurse. |
Other
| Measure | Time frame | Description |
|---|---|---|
| FLACC-scores - Face, Legs, Activity, Cry og Consolability, 0-10, where 10 is the highest pain score, at home | 48 hours | Parental experience with assessment of the FLACC-score at home following discharge. |
Countries
Denmark
Outcome results
None listed