Peri-operative pain management in children and adolescents undergoing scoliosis surgery: pain, nausea and psychological impact
| ISRCTN | ISRCTN12885779 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12885779 |
| EudraCT/CTIS number | 2008-001642-19 |
| Secondary identifying numbers | EudraCT: 2008-001642-19 |
- Submission date
- 20/02/2009
- Registration date
- 15/07/2009
- Last edited
- 17/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mats Karling
Scientific
Scientific
Department of Anesthesia
University Hospital of Nothern Sweden
Umeå
SE 90185
Sweden
| Phone | +46 (0)90 785 0000 |
|---|---|
| mats.karling@vll.se |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Intravenous analgesia with S-ketamine and morphine versus epidural analgesia with fentanyl, bupivacaine and epinephrine: a randomised controlled trial |
| Study acronym | SPIC |
| Study objectives | Patient-controlled intravenous analgesia with morphine and S-ketamine hydrochloride is as effective in pain control with less invasiveness and has comparable or less adverse effects as patient-controlled epidural analgesia with bupivacaine, fentanyl and epinephrine after scoliosis surgery. |
| Ethics approval(s) | Regional Ethics Board of Umea University, Sweden gave approval on 5th December 2008 (ref: 08-056) |
| Health condition(s) or problem(s) studied | Post-operative pain after scoliosis surgery |
| Intervention | In one arm pain treatment consist of a continued epidural infusion of a mixture of bupivacine 1 mg/ml, epinephrine 2 µg/ml and fentanyl 2 µg/ml with patient controlled extra boluses of 0.1 ml/kg to a maximum 5 ml. Initial bolus will be 0.02 ml/kg/segment (maximum of 15 ml) and an initial infusion rate of 0.2 ml/kg/h (maximum of 15 ml/h). Maximal infusion rate inclusive bolus doses will not exceed 0.4 ml/kg/h. The epidural infusion rate is adjusted according to effect and spread. In the other arm pain treatment consists of a continues intravenous infusion of (S)-ketaminehydrochlorid 1 mg/ml 0.1 mg/kg/h and will be started after an initial bolus of 0.25 mg/kg. Morphine 1 mg/ml administered as a Patient Controlled bolus intravenous injection of 25 µg/kg lock out time 6 minutes, after an initial repeated boluses of 50 µg/kg until pain is lower than 30 mm measured with Visual Analogue Scale (VAS) (0 - 100 mm). A continuous infusion of morphine will be started at a rate of 10 µg/kg/h. The bolus dose or the infusion rate will be adjusted according to needs. Background infusion may be increased 5 µg/kg/h until a maximum of 25 µg/kg/h. These treatments will be given for 6 days. Follow up of pain, side effects, bowel function and mobilisation will be as long as the patient is hospitalised (about 9 days) and further 2 weeks at home. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Morphine, S-ketamine hydrochloride, bupivacaine, fentanyl, epinephrine |
| Primary outcome measure | Patients self-report on pain at rest, measured with a Visual Analogue Scale (VAS) (0 - 100 mm, where 0 means no pain and 100 means worst possible pain) every 4 hours during the six first post-operative days. |
| Secondary outcome measures | 1. Pain in motion (during coughing) measured once every 24 hours, VAS (0 - 100 mm) 2. Nausea: defined as 0 = no nausea, 1 = a little nausea, 2 = much nausea, and 3 = vomiting will be monitored every 4 hours and when the patient reports nausea 3. Pruritus defined as: 0 = no pruritus, 1 = pruritus will be monitored when occurring 4. Bowel activity: measured every 12 hours and defined as follows: bowel sounds = 1, first flatus = 2, first tolerated meal = 3, first bowel movement (defined by the patient as defecation) = 4 5. Time to first demanded dose 6. Time to first rescue-analgesia measured from the start of the post-operative study-protocol. Criteria for rescue-administration will be pain, self-report VAS greater than 30 mm in spite of the study protocol for pain management in the respective PCIA and PCEDA groups. 7. Number of demanded PCA-doses 8. Number of rescue doses 9. Total amount of rescue-morphine measured in mg 10. Occurrence of negative psychological effects, as nightmares, hallucinations or confusion 11. A rating of the participants global satisfaction, rated once a day (very satisfied = 0, satisfied = 1, dissatisfied = 2, very dissatisfied = 3) 12. Adherence to mobilisation plan will be recorded daily (0 = plan not fulfilled, 1 = plan fulfilled, 2 = ahead of plan) 13. Length of stay in the hospital (LOS) measured from the day of surgery Outcome-measures in the follow up study will be: 1. The Trauma Symptom Checklist for Children and the adolescents completed at 1 month after returning home 2. Self-reports of common pain and worst pain, will be rated every day, the first 14 days at home after the surgery 3. The adolescents will write a diary on how they experience the first 14 days at home 4. Interviews will be performed 1 month after the surgery |
| Overall study start date | 01/04/2009 |
| Completion date | 01/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 38 |
| Key inclusion criteria | Children and adolescents (aged 12 - 18 years, either sex) with idiopathic scoliosis scheduled for correction by posterior spinal fusion. |
| Key exclusion criteria | 1. Pregnant 2. Allergic to study drugs 3. Unable to present self reports on pain and nausea |
| Date of first enrolment | 01/04/2009 |
| Date of final enrolment | 01/04/2011 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Department of Anesthesia
Umeå
SE 90185
Sweden
SE 90185
Sweden
Sponsor information
University Hospital of Northern Sweden (University Hospital of Umeå)
Hospital/treatment centre
Hospital/treatment centre
c/o Mats Karling
Department of Anaesthesia
Umeå
SE 90185
Sweden
| Phone | +46 (0)90 785 0000 |
|---|---|
| mats.karling@vll.se | |
"ROR" |
https://ror.org/012k96e85 |
Funders
Funder type
Government
Västerbotten Läns Landsting
Government organisation / Local government
Government organisation / Local government
- Alternative name(s)
- Västerbotten County Council
- Location
- Sweden
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
17/01/2020: Internal review.
