Health TrialsbyHealthPanel

Evaluation of Analgesia for Spine Fusion Elective Surgery in Children

ConditionIdiopathic Scoliosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age10-18
SponsorSenthil Sadhasivam

About this trial

The multicenter PRECISE Analgesia (Prospective Randomized Evaluation of Analgesia for Idiopathic Scoliosis Spine Fusion Elective Surgery in Children) trials will a) implement and investigate the efficacy and safety of multidose methadone-based standardized enhanced recovery after surgery (ERAS) protocol, and b) develop personalized ERAS protocols including precision methadone and oxycodone dosing and c) personalized analgesia for the safe and effective opioid-sparing management of surgical pain after posterior spine fusion (PSF) in children.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 10 - < 18 years

American Society of Anesthesiologists (ASA) Physical Status 1 or 2

Undergoing PSF for idiopathic scoliosis

Participant or legal guardian can speak and read English or Spanish

Disqualifiers

Pregnant patients

Methadone allergy

Preoperative prolonged QTc more than 460 msec (-30 days to 0 day)

Subjects undergoing concomitant treatment with known cytochrome P450 inhibitors included in methadone labeling (i.e. macrolides (e.g. erythromycin), azole-antifungal agents (e.g. ketoconazole, voriconazole), protease inhibitors (e.g. ritonavir), fluconazole, SSRIs (e.g. sertraline, fluvoxamine)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Methadone based ERAS

    Drug

    Methadone intervention includes intraoperative intravenous methadone (1st dose: 0.1 mg/kg up to a maximum of 5 mg before incision; 2nd dose: 0.1 mg/kg up to a maximum of 5 mg administered 4 hours after the 1st dose) and postoperatively, up to 4 additional IV or oral doses of methadone (0.1 mg/kg up to a maximum of 5 mg) every 12 hours before discharge as part of standardized multimodal analgesia in the hospital setting.

  • Non-methadone based group

    Drug

    Non-methadone intervention includes standard opioid analgesia protocol without intra- and post-operative methadone per the current site standards. Postoperative pain medication is recommended when reported pain level is considered moderate or higher (≥4 on NRS and FLACC).

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Methadone-Based ERAS GroupExperimental treatment 1 intervention
Group B: Non-Methadone-Based GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Average postoperative pain scores

Average postoperative pain scores at 48-hours timepoint using 0-10, Numerical Rating Scale (NRS), in which 0=no pain at all and 10=worst pain imaginable. Outcome will be reported based on area under the curve (AUC) as mean(SD).

Time frame
Postoperative 48 hours
2

Total postoperative opioid use

Number of opioids used in hospital, will be reported as mean (SD).

Time frame
Postoperative 48 hours

Secondary outcomes

1

Incidence of inpatient respiratory depression (RD)

RD is defined as persistent oxygen desaturation (SpO2) \<90% on room air or respiratory rate \<8 breaths per minute requiring oxygen in the absence of airway obstruction. Outcome will be reported as n(%).

Time frame
Postoperative 120-hours
2

Incidence of Postoperative Nausea and Vomiting (PONV)

PONV will be assessed by self-report, EMR, and medication use. Outcome will be reported as n(%).

Time frame
Postoperative 120-hours
3

Incidence of Inpatient Sedation

Sedation will be assessed using the Ramsay Sedation Scale (RSS) and validated sedation scales extracted from the EMR. Outcome will be reported as n(%).

Time frame
Postoperative 120-hours
4

QTc Prolongation

QTc prolongation is defined as \>460 msec based on 12-lead or 15-lead EKG. Outcome will be reported as n(%).

Time frame
Postoperative 48-hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Senthil Sadhasivam

Lead sponsor

University of Pittsburgh

Sponsor institution

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov
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