on-inferiority of TENS to analgosedation during lumbar puncture in children and adolescents - a prospective, controlled preference trial

Phase 3

Recruiting

Conditions: npleasantness and pain during pediatric lumbar puncture

Registration Number: DRKS00025539

Lead Sponsor: Interdisziplinäre Schmerzambulanz, Campus Innenstadt, Klinik für Anaesthesiologie, LMU Klinikum, LMU München

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 86

Inclusion Criteria

•Electively lumbar puncture with or without intrathecal administration of medication
•Consent of the physician conducting the LP
•Children six to 17 years who are able to operate the TENS device themselves (developed according to their age, no language barriers)

Exclusion Criteria

•Expected difficult LP due to anatomical characteristics (severe scoliosis, status after spinal surgery)
•Obligatory premedication e.g. due to trauma experience
•Diagnostic / therapeutic LP with CSF pressure measurement in cases of suspected or known pseudotumor cerebri
•Contraindication to TENS (pacemaker, epilepsy)
• Long COVID syndrome associated with elevated anxiety and hyperalgesia

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients’ unpleasantness of the entire procedure (analgosedation group: including venous access) as evaluated by the visual analog scale VAS (0-100, with 0 not unpleasant at all, 100 maximally uncomfortable) two hours after end of the lumbar puncture (plaster on)

Secondary Outcome Measures

Name	Time	Method
•Patients’ maximum pain intensity during the entire procedure (analgosedation group: including venous access) as evaluated by VAS (0-100, with 0 = no pain, 100 = maximum pain) two hours after the procedure<br>•Duration of the LP from skin disinfection to plaster on<br>•Anesthesia presence time plus premedication time determined from the documents (anesthesia protocol, premedication sheet)<br>•Behavioral observation during the procedure (PBCL- Problem Behavior Checklist)<br>•Satisfaction with the procedure, survey with CSAT (very satisfied, satisfied, don't know / neutral, dissatisfied, very dissatisfied),<br>-after the procedure: puncturing doctor<br>-two hours after the procedure on the ward: patient<br>-two hours after the procedure on the ward: a legal representative (interviewed separately from the patient)<br>•Credibility of both procedures (according to Vincent & Lewith) before and after the procedure<br>•Adverse events during the recovery phase