Topical Analgesia Before Inhalational Anaesthesia

Anesthesia Clinical Trial

Official title:

Topical Analgesia Before Inhalational Anaesthesia: A Retrospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04959409
• Other study ID #: 20AN008
• Status: Completed
• Start date: August 1, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: July 2021
• Source: Nottingham University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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:

• Children receiving an attempted awake venous cannula insertion
• Children receiving an a failed intravenous induction of anaesthesia prior to an inhalational induction of anaesthesia
• Child or family history of malignant hyperthermia
• Congenital or idiopathic methaemoglobinaemia
• Glucose-6-phosphate dehydrogenase deficiency (G6PD)
• Known sensitivity to topical analgesia
• Use of analgesics within the preceding 24 hours

Related Conditions & MeSH terms

• Anesthesia
• Pediatric ALL

Intervention

Drug:
• Topical analgesia (EMLA or AMETOP)
Whether topical analgesia has or has not been administered to each child prior to them receiving an inhalational induction of anaesthesia

Locations

Country	Name	City	State
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (21)

Antognini JF, Carstens E. Isoflurane blunts electroencephalographic and thalamic-reticular formation responses to noxious stimulation in goats. Anesthesiology. 1999 Dec;91(6):1770-9. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Hart D, Bossert E. Self-reported fears of hospitalized school-age children. J Pediatr Nurs. 1994 Apr;9(2):83-90. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2014;3:CD004236. — View Citation

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. Review. — View Citation

Manner T, Kanto J, Iisalo E, Lindberg R, Viinamäki 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. — View Citation

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. — View Citation

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. Review. — View Citation

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):1370-4, table of contents. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Tracey I, Mantyh PW. The cerebral signature for pain perception and its modulation. Neuron. 2007 Aug 2;55(3):377-91. Review. — View Citation

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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)
Secondary	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')