AnesthesiaNCT04959409
Topical Analgesia Before Inhalational Anaesthesia
An observational study of Anesthesia and Pediatric ALL, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 1 month to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Pediatric ALL
- What is being tested?
- Topical analgesia (EMLA or AMETOP)
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2020to 31 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 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
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, NG7 2UH
About this study
Official title: Topical Analgesia Before Inhalational Anaesthesia: A Retrospective Observational Study
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.
Read the detailed 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.
- Conditions
- Anesthesia, Pediatric ALL
- Being tested
- Topical analgesia (EMLA or AMETOP)
- Keywords
- Topical analgesia, Inhalational anaesthesia
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Exposed Cohort | Children receiving topical analgesia Receives: Drug: Topical analgesia (EMLA or AMETOP) | |
| Control / Unexposed Cohort | Children who do not receive topical analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 outcomes (2)
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))
Measured: 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)
Overall anaesthetic time
Proxy marker of duration of time to complete cannulation procedure
Measured: 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')
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start1 Aug 2020
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- M Billingham, MB.ChB, Principal investigator, Nottingham University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959409
- Sponsor's protocol ID
- 20AN008
- Status last verified
- Jul 2021
- First submitted
- 7 Jun 2021
- Last updated
- 13 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be disclosed
Publications
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.
PubMed 26352920Hart D, Bossert E. Self-reported fears of hospitalized school-age children. J Pediatr Nurs. 1994 Apr;9(2):83-90.
PubMed 8027944Kortesluoma 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.
PubMed 15358886Lee 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.
PubMed 24488733Eccleston 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.
PubMed 33064998Lander 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.
PubMed 8867250Lander 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.
PubMed 16856039Manner 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.
PubMed 3434165Maunuksela 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.
PubMed 3535860Woolfson 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.
PubMed 2206789Tracey 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.
PubMed 17678852Otto 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.
PubMed 18348766Otto 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.
PubMed 12893158Bischoff 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.
PubMed 8695077Hagihira 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.
PubMed 15087616
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Analgesia Before Inhalational Anaesthesia: A Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT04959409
- Acronym / sponsor ID
- 20AN008
- Conditions
- Anesthesia, Pediatric ALL
- Keywords
- Topical analgesia, Inhalational anaesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 13 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed Cohort | – | Drug: Topical analgesia (EMLA or AMETOP)Children receiving topical analgesia |
| Control / Unexposed Cohort | – | –Children who do not receive topical analgesia |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 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
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Exposed Cohort |
Primary outcome
Patient movement
Time frame: 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)
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
2 secondary outcomes
FTSI (first time successful insertion) of cannula
Time frame: 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)
Overall anaesthetic time
Time frame: 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')
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Background: PubMed 26352920McMurtry 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.
- Background: PubMed 8027944Hart D, Bossert E. Self-reported fears of hospitalized school-age children. J Pediatr Nurs. 1994 Apr;9(2):83-90.
- Background: PubMed 15358886Kortesluoma 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.
- Background: PubMed 24488733Lee 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.
- Background: PubMed 33064998Eccleston 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.
- Background: PubMed 8867250Lander 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.
- Background: PubMed 16856039Lander 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.
- Background: PubMed 3434165Manner 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.
- Background: PubMed 3535860Maunuksela 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.
- Background: PubMed 2206789Woolfson 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.
- Background: PubMed 17678852Tracey 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.
- Background: PubMed 18348766Otto 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.
- Individual participant dataSharing planned: No. No individual participant data will be disclosed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M Billingham, MB.ChB principal investigator
Nottingham University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Pediatric ALL, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient movement (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04959409, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.