Wounds and Injuries

All Conditions

pillow

We have developed a positioning cushion for LP which allows the child to be relaxed in an adequate position, and to maintain this position throughout LP. This study was aimed at evaluating the benefit of the device on the technical quality of LPs, on pain, anxiety, post LP syndrome, and on the satisfaction of children, their parents and caregivers.

The study was a two-centre, open, randomized trial, with two parallel groups. Children aged 2 to 18 years undergoing a LP were eligible, if not included in the study before. Those who had used the cushion before, with a medical reason preventing the use of the cushion, those refusing or whose parents refused could not be included. Randomization was stratified by centre.

Four cushion sizes were available for the age ranges: 2-6 years, 6-10 years, 10-15 and 15-18 years. The primary outcome was the rate of success, defined as a LP reaching its objective at the first attempt, without hemorrhage (visible hemorrhage or RBC \> 50/mm3 in the CSF sample). Secondary outcomes included: the child's pain using a visual analogic scale (VAS), parents and caregiver perception of the child's pain (VAS); the children, parents, caregiver and physician performing the LP satisfaction; children cooperation using the "Le Baron Scale", and the occurrence of a post LP syndrome.

Our study was an open, randomized, controlled trial, with two parallel groups assigned to "LP pillow" or "no intervention" conducted in patients undergoing LP.

Participants Children aged 2 to 18 years undergoing an LP were eligible for inclusion. Children who had already participated or used the LP pillow, who had a medical condition (orthopaedic anomaly) contraindicating the use of the LP pillow or whose parents refused consent were excluded.

A permuted-block algorithm was used for randomization, with participants stratified according to centre. Concealed allocation was achieved by a phone call to the coordination centre after eligibility check and baseline data collection.

Intervention The LP pillow was made of polyethylene microcellular foam, coated with rubber to facilitate decontamination. It was placed on the thighs of the child sitting with the trunk leaning forward. This position ensures maximum lumbar flexion whereas resting the trunk on the pillow allows relaxation of paravertebral muscles. The axis of the body and the spinal column were maintained perfectly symmetrical in the sagittal plane (see illustration Fig 1).

The pillow included side supports for the head; the face remained uncovered so that the child could breathe and speak comfortably; this also facilitated nitrous oxide administration. Props supporting the patient's arms maintained the cervical column in a neutral position. An opening allowed touching the child's hands and forearms. Splints at the bottom side immobilized the child's thighs to ensure effective stabilization.

Four sizes were available corresponding approximately to the following age ranges: 2-6 years, 6-10 years, 10-15 and 15-18 years. Two sets were available for the study, one per centre.

Outcomes Primary outcome was the technical quality of the LP, classified as success or failure. A successful LP is defined as one that achieves its purpose (sampling and/or treatment) at the first attempt, without visible haemorrhage and with RBC \< 50/mm3 in the cerebrospinal fluid (CSF) sample (biochemical analysis).

Secondary outcomes included: child's pain, evaluated by self-administered visual analogical scales (VAS) for children over 6 years of age; parents' and caregivers' perception of the child's pain; satisfaction of the children, parents, caregivers and physician performing the LP assessed using verbal scoring; child cooperation rated with the "LeBaron Scale" (Lebaron 1984). Other outcomes included the number of attending persons (parents and/ or caregivers); duration of positioning and procedure; incidence, symptoms and duration of post-LP syndrome assessed 48 hours after LP by phone interview.

Data collection included anaesthetic, sedative and analgesic drugs used; needle size (19G, 20G, 22G); general status of the child evaluated with Karnofsky or Lansky score (Lansky 1985); platelet count; number of previous LP; date of and satisfaction with the last LP (verbal scale), practitioner experience in performing LP, presence of the parents, aim of the LP: diagnosis, therapeutic monitoring, treatment injection; amount of CSF removed (drops).

The study protocol was approved by the institutional review board of Lyon A - Hôtel-Dieu on June 8th 2004, and was conducted in accordance with the Helsinki Declaration. All parents gave written informed consent before participation of their child. Children were asked to give written consent when fully able to understand the proposed procedure.

Data were managed using CLININFO S.A. (France) software and services for clinical trial data management and quality control.

Sample size and statistical analysis The protocol initially included a total of 80 children. The sample size calculation was based on a rate of success of 70% in the control group and 95% in the pillow group, with 80%-power and 0.05 two-sided significance level (N Query® software). Based on the rate of success in the control group after inclusion of the 40th child, the sample size was re-estimated and increased to 124 children (62 per group) and the inclusion period was extended from 12 to 24 months. Comparisons between groups were performed using non parametric methods, i.e. the Wilcoxon rank test or the Fisher's exact test, depending on the nature of the variable. A logistic regression model was fitted to the platelet count and the number of LP prior to entering the study. An exploratory subgroup analysis was performed in children over 6 years of age. Comparisons with p-value less than 0.05 were considered significant. The STATA 9.2 (SatatCorp 2005. Stata Statistical Software: Release 9.0 College Station, TX: Satat Corporation) software was used to perform statistical analyses.

Randomized Evaluation of a Positioning Pillow for Lumbar Puncture in Paediatric Hematology-Oncology

Hopital Debrousse

Centre Leon Berard

Perrine MAREC-BERARD

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Lidocaine

Propofol

Remifentanil

Hypnotics and Sedatives

Anesthetics

Anesthetics, Intravenous

Anesthetics, General

Analgesics, Opioid

Narcotics

Patients in this arm of the study will receive 2.0 mg/kg propofol + 1.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.

Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg

Patients in this arm of the study will receive 4.0 mg/kg propofol + 0.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.

Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg

Jason Hayes, MD

The objective of this study is to compare intraoperative and recovery parameters in patients who receive two different dose combinations of propofol and remifentanil in patients undergoing a lumbar puncture.

Lumbar punctures (LP) are performed in approximately one thousand oncology patients per year at the Hospital for Sick Children. In a previous study, we determined the optimal dose of remifentanil which provides effective anesthesia with little or no movement during LP in children. The present study will determine the optimal dose combination of propofol and remifentanil to keep patients comfortable and still during the procedure while decreasing the incidence of side effects and allows for shorter recovery times and earlier discharge from the recovery room.

Co-administration of Propofol and Remifentanil for Lumbar Puncture in Children

Co-administration of Propofol and Remifentanil for Lumbar Puncture in Children: Evaluation of Two Dose Combinations

The Hospital for Sick Children

Staff Anesthesiologist

Propofol + Remifentanil: Patients in this arm of the study will receive 2.0 mg/kg propofol + 1.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.

2.0 mg/kg Propofol and 1.5 ug/kg Remifentanil

Propofol + Remifentanil: Patients in this arm of the study will receive 4.0 mg/kg propofol + 0.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.

4.0 mg/kg Propofol + 0.5 ug/kg Remifentanil

4.0 mg/kg Propofol and 0.5 ug/kg Remifentanil

Total

Age, Continuous

Sex: Female, Male

Dr. Jason Hayes

2.0 mg/kg Propofol

4.0 mg/kg Propofol

Duration of Apnea

Duration of Postoperative Recovery (Time to Spontaneous Eye Opening, Verbalization, Purposeful Movement).

Incidence of Adverse Events and Clinically Significant Changes in Routine Vital Signs as Measured by Electrocardiogram, Non-invasive Blood Pressure, and Pulse Oximeter.

Overall Study

Blood and Lymph Conditions

Hematologic Diseases

First patient in this arm will receive a bolus of propofol 4 mg/kg followed by remifentanil 0.5 mcg/kg. Subsequent patients randomized to this arm will receive propofol 4 mg/kg but the dose of remifentanil will be determined using the Dixon up-and-down method (i.e. based on the response of the previous patient)

First patient in this arm will receive a bolus of propofol 2 mg/kg followed by remifentanil 1 mcg/kg. Subsequent patients randomized to this arm will receive propofol 2 mg/kg but the dose of remifentanil will be determined using the Dixon up-and-down method (i.e. based on the response of the previous patient)

The first patient in this group will receive 4 mg/kg propofol and 0.5 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.

The first patient in this group will receive 2 mg/kg propofol and 1.0 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.

This study will examine whether the combination of two anaesthetic medications, propofol and remifentanil, is suitable for short duration surgical procedures, providing a shorter recovery time and fewer side effects than either drug used alone.

Propofol is the primary medication used by anesthesiologists at HSC to provide sedation for lumbar puncture. Propofol provides amnesia, anxiolysis, and hypnosis, but because propofol has no analgestic properties patients often respond to the pain of LP needle insertion. To ensure patient immobility, the dose of propofol is often increased, resulting in a duration of action that is excessive for lumbar puncture. Remifentanil is an ultra-short acting opioid which can be used to provide analgesia and sedation for short painful procedures with minimal residual pain. However, when used as the sole agent, remifentanil is associated with a high incidence of respiratory depression and/or arterial oxygen desaturation and does not provide amnesia or anxiolysis. The combination of propofol and remifentanil may be particularly suitable for short duration procedures, providing a shorter recovery time and fewer side effects than either drug used alone.

The objective is to determine the minimum effective dose of remifentanil required to prevent movement for insertion of a lumbar puncture needle when co-administered with propofol. The results obtained from this study will be used in a future study of the recovery characteristics of propofol and remifentanil in children undergoing lumbar puncture.

A Dose Finding Study of Remifentanil and Propofol for Lumbar Punctures in Children

The Minimum Effective Dose of Remifentanil When Co-administered With Propofol for Lumbar Puncture in Children: A Dose-finding Study

Minimum effective dose (Dixon methodology) and ED98 required to prevent movement during lumbar puncture needle insertion

Remifentanil: The first patient in this group will receive 4 mg/kg propofol and 0.5 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.

Propofol 4 mg/kg

Remifentanil: The first patient in this group will receive 2 mg/kg propofol and 1.0 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.

Propofol 2mg/kg

Propofol 4mg/kg

Minimum effective dose

ED98

Minimum effective dose of remifentanil to prevent movement during lumbar puncture insertion

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Randomized Evaluation of a Positioning Pillow for Lumbar Puncture in Paediatric Hematology-Oncology	NCT00775112	Spinal Puncture	pillow	2 Years - 18 Years	Centre Leon Berard
Co-administration of Propofol and Remifentanil for Lumbar Puncture in Children	NCT00405522	Spinal Puncture	Propofol 2.0 mg... Propofol 4.0 mg...	3 Years - 12 Years	The Hospital for Sick Children
Co-administration of Propofol and Remifentanil for Lumbar Puncture in Children	NCT00405522	Spinal Puncture	Propofol 2.0 mg... Propofol 4.0 mg...	3 Years - 12 Years	The Hospital for Sick Children
A Dose Finding Study of Remifentanil and Propofol for Lumbar Punctures in Children	NCT00213239	Hematologic Dis... Neoplasms	Remifentanil Remifentanil	4 Years - 11 Years	The Hospital for Sick Children
A Dose Finding Study of Remifentanil and Propofol for Lumbar Punctures in Children	NCT00213239	Hematologic Dis... Neoplasms	Remifentanil Remifentanil	4 Years - 11 Years	The Hospital for Sick Children

Spots Global Cancer Trial Database for spinal puncture