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
Clinical Trials Information System (CTIS)	2008-001642-19
Protocol serial number	EudraCT: 2008-001642-19
Sponsor	University Hospital of Northern Sweden (University Hospital of Umeå)
Funder	Västerbotten Läns Landsting

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

Department of Anesthesia
University Hospital of Nothern Sweden
Umeå
SE 90185
Sweden

Phone	+46 (0)90 785 0000
Email	mats.karling@vll.se

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Morphine, S-ketamine hydrochloride, bupivacaine, fentanyl, epinephrine
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/04/2011

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

17/01/2020: Internal review.