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Peripheral venous cannulation (insertion of a drip line into a vein) is a fundamental component of anaesthesia for both children and adults alike. Discomfort caused by needle insertion is a common worry for children but one simple intervention that may be delivered prior to a needle insertion procedure, is the application of topical analgesia (numbing skin cream). Several creams are now available and have been found to be effective in several trials of awake children. Yet the value of these creams for children receiving an inhalational induction of anaesthesia (gas to go off to sleep before needle insertion) remains uncertain.
The aims of this study are to determine whether cream application prior to receiving gas to go off to sleep has any beneficial effects (outcomes) for children, including reduction of movement, improved needle success rates and reduced time required for needle insertion procedures. How frequently skin effects after application of the creams occur (swelling, redness, itchiness) will also be assessed.
This study will be performed as a retrospective observational study (a study which looks back in time, identifies groups of exposed (cream applied) or non-exposed (no cream applied) children and follows them over a period of time to see how their exposures affect their outcomes). Using a total population (purposive) sampling technique, 500 children from 1 month to 18 years of age undergoing elective (planned) or urgent (emergency) inhalational induction of anaesthesia (gas to go off to sleep) at Nottingham University Hospitals NHS Trust over a six month study period (August 2020 to January 2021) will be incorporated into a completely anonymised research dataset and analysed to determine whether topical analgesia (skin numbing cream) application prior to inhalational induction (gas to go off to sleep) may offer any beneficial effects for paediatric patients.
This study will be performed as a retrospective cohort observational study (a study which looks back in time, identifies cohorts (groups) of 'exposed' (those who received topical analgesia (skin numbing cream)) and 'non-exposed' (those who did not receive topical analgesia (skin numbing cream)) children and follows them over a period of time to see how their exposures affect their outcomes).
Since no studies have been conducted to date, to determine the value of topical analgesia (skin numbing cream) for children receiving an inhalational induction of anaesthesia (gas to go off to sleep), this has been designed as a non-randomised preparatory study. Being non-experimental in nature, this study will attempt to evaluate preliminary null hypotheses of association. Where association(s) and/or potential benefit(s) are observed to a statistically significant level, the value and feasibility of a future experimental study, in the form of a prospective randomised controlled trial, will be evaluated.
Through acting as a first step in exploring a novel intervention, this approach is felt to offer a safe and cost-effective indication of the value a future large-scale experimental trial, which in an uninvestigated field and with only a suggestible potential for benefit, would face numerous approval challenges.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposed Cohort | Children receiving topical analgesia |
| |
| Control / Unexposed Cohort | Children who do not receive topical analgesia |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical analgesia (EMLA or AMETOP) | Drug | Whether topical analgesia has or has not been administered to each child prior to them receiving an inhalational induction of anaesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Patient movement | To be used as a surrogate marker of pain. Movement will be defined as reflex hand and/or arm withdrawal and/or the initiation of excitatory movement(s) at the time of needle insertion | Prospective recording by anaesthetist / member of usual care team within 30 minutes of induction of anaesthesia (with completed records stored in RCoA Logbook and Anaesthetic charts) |
| Measure | Description | Time Frame |
|---|---|---|
| FTSI (first time successful insertion) of cannula | Rate of FTSI (first time successful insertion) of cannula (with success defined as skin breached only once and the ability to freely instil 5 ml of normal saline intravenously (into the vein)) | Prospective recording by anaesthetist / member of usual care team within 60 minutes of induction of anaesthesia (with completed records stored in RCoA Logbook and Perioperative Care Record) |
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Inclusion Criteria:
• All children from 1 month to 18 years of age undergoing elective or urgent inhalational induction of anaesthesia at Nottingham University Hospitals NHS Trust over a six month study period (August 2020 to January 2021)
Exclusion Criteria:
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Of the children who may become study participants (identified as being eligible and not meeting the study exclusion criteria) a random sampling technique will be utilised to recruit 500 children
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| Name | Affiliation | Role |
|---|---|---|
| M Billingham, MB.ChB | Nottingham University Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nottingham University Hospitals NHS Trust | Nottingham | Nottinghamshire | NG7 2UH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26352920 | Background | McMurtry CM, Pillai Riddell R, Taddio A, Racine N, Asmundson GJ, Noel M, Chambers CT, Shah V; HELPinKids&Adults Team. Far From "Just a Poke": Common Painful Needle Procedures and the Development of Needle Fear. Clin J Pain. 2015 Oct;31(10 Suppl):S3-11. doi: 10.1097/AJP.0000000000000272. | |
| 8027944 | Background |
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No individual participant data will be disclosed
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 7, 2021 | Jun 5, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Not provided
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000077442 | Lidocaine, Prilocaine Drug Combination |
| D013748 | Tetracaine |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
| D008012 | Lidocaine |
| D000083 | Acetanilides |
| D000813 | Anilides |
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| Overall anaesthetic time | Proxy marker of duration of time to complete cannulation procedure | Prospective recording by member of usual care team within 30 minutes of induction of anaesthesia (with Theatre records retrospectively analysed by research team for 'Anaesthetic Start time to (arrival in) Theatre') |
| Hart D, Bossert E. Self-reported fears of hospitalized school-age children. J Pediatr Nurs. 1994 Apr;9(2):83-90. |
| 15358886 | Background | Kortesluoma RL, Nikkonen M. 'I had this horrible pain': the sources and causes of pain experiences in 4- to 11-year-old hospitalized children. J Child Health Care. 2004 Sep;8(3):210-31. doi: 10.1177/1367493504045822. |
| 24488733 | Background | Lee GY, Yamada J, Kyololo O, Shorkey A, Stevens B. Pediatric clinical practice guidelines for acute procedural pain: a systematic review. Pediatrics. 2014 Mar;133(3):500-15. doi: 10.1542/peds.2013-2744. Epub 2014 Feb 2. |
| 33064998 | Background | Eccleston C, Fisher E, Howard RF, Slater R, Forgeron P, Palermo TM, Birnie KA, Anderson BJ, Chambers CT, Crombez G, Ljungman G, Jordan I, Jordan Z, Roberts C, Schechter N, Sieberg CB, Tibboel D, Walker SM, Wilkinson D, Wood C. Delivering transformative action in paediatric pain: a Lancet Child & Adolescent Health Commission. Lancet Child Adolesc Health. 2021 Jan;5(1):47-87. doi: 10.1016/S2352-4642(20)30277-7. Epub 2020 Oct 13. No abstract available. |
| 8867250 | Background | Lander J, Hodgins M, Nazarali S, McTavish J, Ouellette J, Friesen E. Determinants of success and failure of EMLA. Pain. 1996 Jan;64(1):89-97. doi: 10.1016/0304-3959(95)00100-X. |
| 16856039 | Background | Lander JA, Weltman BJ, So SS. EMLA and amethocaine for reduction of children's pain associated with needle insertion. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD004236. doi: 10.1002/14651858.CD004236.pub2. |
| 3434165 | Background | Manner T, Kanto J, Iisalo E, Lindberg R, Viinamaki O, Scheinin M. Reduction of pain at venous cannulation in children with a eutectic mixture of lidocaine and prilocaine (EMLA cream): comparison with placebo cream and no local premedication. Acta Anaesthesiol Scand. 1987 Nov;31(8):735-9. doi: 10.1111/j.1399-6576.1987.tb02655.x. |
| 3535860 | Background | Maunuksela EL, Korpela R. Double-blind evaluation of a lignocaine-prilocaine cream (EMLA) in children. Effect on the pain associated with venous cannulation. Br J Anaesth. 1986 Nov;58(11):1242-5. doi: 10.1093/bja/58.11.1242. |
| 2206789 | Background | Woolfson AD, McCafferty DF, Boston V. Clinical experiences with a novel percutaneous amethocaine preparation: prevention of pain due to venepuncture in children. Br J Clin Pharmacol. 1990 Aug;30(2):273-9. doi: 10.1111/j.1365-2125.1990.tb03775.x. |
| 17678852 | Background | Tracey I, Mantyh PW. The cerebral signature for pain perception and its modulation. Neuron. 2007 Aug 2;55(3):377-91. doi: 10.1016/j.neuron.2007.07.012. |
| 18348766 | Background | Otto KA. EEG power spectrum analysis for monitoring depth of anaesthesia during experimental surgery. Lab Anim. 2008 Jan;42(1):45-61. doi: 10.1258/la.2007.006025. |
| 12893158 | Background | Otto KA, Mally P. Noxious stimulation during orthopaedic surgery results in EEG 'arousal' or 'paradoxical arousal' reaction in isoflurane-anaesthetised sheep. Res Vet Sci. 2003 Oct;75(2):103-12. doi: 10.1016/s0034-5288(03)00077-8. |
| 8695077 | Background | Bischoff P, Kochs E, Haferkorn D, Schulte am Esch J. Intraoperative EEG changes in relation to the surgical procedure during isoflurane-nitrous oxide anesthesia: hysterectomy versus mastectomy. J Clin Anesth. 1996 Feb;8(1):36-43. doi: 10.1016/0952-8180(95)00170-0. |
| 15087616 | Background | Hagihira S, Takashina M, Mori T, Ueyama H, Mashimo T. Electroencephalographic bicoherence is sensitive to noxious stimuli during isoflurane or sevoflurane anesthesia. Anesthesiology. 2004 Apr;100(4):818-25. doi: 10.1097/00000542-200404000-00011. |
| 8017642 | Background | Kochs E, Bischoff P, Pichlmeier U, Schulte am Esch J. Surgical stimulation induces changes in brain electrical activity during isoflurane/nitrous oxide anesthesia. A topographic electroencephalographic analysis. Anesthesiology. 1994 May;80(5):1026-34. doi: 10.1097/00000542-199405000-00012. |
| 15845688 | Background | Morimoto Y, Matsumoto A, Koizumi Y, Gohara T, Sakabe T, Hagihira S. Changes in the bispectral index during intraabdominal irrigation in patients anesthetized with nitrous oxide and sevoflurane. Anesth Analg. 2005 May;100(5):1370-1374. doi: 10.1213/01.ANE.0000148124.02288.D1. |
| 20680669 | Background | Sleigh JW, Leslie K, Voss L. The effect of skin incision on the electroencephalogram during general anesthesia maintained with propofol or desflurane. J Clin Monit Comput. 2010 Aug;24(4):307-18. doi: 10.1007/s10877-010-9251-3. Epub 2010 Aug 1. |
| 25218826 | Background | Hartley C, Poorun R, Goksan S, Worley A, Boyd S, Rogers R, Ali T, Slater R. Noxious stimulation in children receiving general anaesthesia evokes an increase in delta frequency brain activity. Pain. 2014 Nov;155(11):2368-76. doi: 10.1016/j.pain.2014.09.006. Epub 2014 Sep 10. |
| 10598621 | Background | Antognini JF, Carstens E. Isoflurane blunts electroencephalographic and thalamic-reticular formation responses to noxious stimulation in goats. Anesthesiology. 1999 Dec;91(6):1770-9. doi: 10.1097/00000542-199912000-00031. |
| 16492836 | Background | Kox WJ, von Heymann C, Heinze J, Prichep LS, John ER, Rundshagen I. Electroencephalographic mapping during routine clinical practice: cortical arousal during tracheal intubation? Anesth Analg. 2006 Mar;102(3):825-31. doi: 10.1213/01.ane.0000197776.26307.fa. |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000577 |
| Amides |
| D009930 | Organic Chemicals |
| D011318 | Prilocaine |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |