Unpleasantness and pain during pediatric lumbar puncture
Conditions
Interventions
Group 1: Transcutaneous electrical nerve stimulation (TENS): During the premedication visit instructions about the TENS device (TENStem ecobase, Firma schwa-medico) are provided, and two stimulation p
Sponsors
Interdisziplinäre Schmerzambulanz, Campus Innenstadt, Klinik für Anaesthesiologie, LMU Klinikum, LMU München
Eligibility
Sex/Gender
All
Age
6 Years to 17 Years
Inclusion criteria
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) • Sufficient command of the German language of the child • Sufficient command of the German language of the accompanying parent / custodian
Exclusion criteria
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 and age below 14 years • Diagnostic / therapeutic LP with CSF pressure measurement in cases of suspected or known pseudotumor cerebri and body-mass-index (BMI) 30 or larger • Diagnostic / therapeutic LP with follow-up 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| • 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 • Duration of the LP from skin disinfection to plaster on • Anesthesia presence time plus premedication time determined from the documents (anesthesia protocol, premedication sheet) • Behavioral observation during the procedure (PBCL- Procedure Behavior Checklist) • Satisfaction with the procedure, survey with CSAT (very satisfied, satisfied, don't know / neutral, dissatisfied, very dissatisfied), - after the procedure: puncturing doctor - two hours after the procedure on the ward: patient - two hours after the procedure on the ward: a legal representative (interviewed separately from the patient) • Credibility of both procedures (according to Vincent & Lewith) before and after the procedure • Adverse events during the recovery phase | — |
Countries
Germany
Contacts
Public ContactHeike Kunze-Kronawitter
Interdisziplinäre Schmerzambulanz, Klinik für Anaesthesiologie, Campus Innenstadt, LMU Klinikum, LMU München
Outcome results
None listed