Randomized trial of novel tetracaine patch to provide local anaesthesia in neonates undergoing venepuncture
Procedures such as venepuncture or heel prick are painful and may cause considerable stress to newborn infants. Topical local anaesthetics are effective for venepuncture but need to be applied for at least 60 min and the delivered dose will vary. We assessed a novel tetracaine-based self-adhesive pa...
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| Published in: | British journal of anaesthesia : BJA Vol. 91; no. 4; pp. 514 - 518 |
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| Main Authors: | , , , , , |
| Format: | Journal Article |
| Language: | English |
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01-10-2003
Oxford University Press Oxford Publishing Limited (England) |
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| Abstract | Procedures such as venepuncture or heel prick are painful and may cause considerable stress to newborn infants. Topical local anaesthetics are effective for venepuncture but need to be applied for at least 60 min and the delivered dose will vary. We assessed a novel tetracaine-based self-adhesive patch in providing controlled local anaesthesia before venepuncture.
A placebo-controlled, double-blind trial was conducted using a tetracaine patch formulated from hydroxypropylcellulose discs (0.283 cm2) containing tetracaine (1 mg cm−2) surrounded by a low tack pressure-sensitive adhesive backing layer. Thirty-two newborn infants of gestation 32–42 weeks (median 36 weeks), aged 3–18 days (median 6 days) were randomized to receive a tetracaine-containing patch or a placebo device applied to the dorsum of the hand 30 min before venepuncture to obtain blood samples. Pain was assessed in response to needle insertion using a validated adaptation of the neonatal facial coding score (NFCS) and the presence of crying.
Of 15 tetracaine-treated neonates, 14 (93%) presented little or no pain in response to the procedure compared with six of 17 (35%) who had the placebo patch applied (P=0.01).
The tetracaine patch produced effective pain relief during the venepuncture procedure in both term and pre-term infants. There were no adverse effects, either local or systemic. |
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| AbstractList | Procedures such as venepuncture or heel prick are painful and may cause considerable stress to newborn infants. Topical local anaesthetics are effective for venepuncture but need to be applied for at least 60 min and the delivered dose will vary. We assessed a novel tetracaine-based self-adhesive patch in providing controlled local anaesthesia before venepuncture.
A placebo-controlled, double-blind trial was conducted using a tetracaine patch formulated from hydroxypropylcellulose discs (0.283 cm(2)) containing tetracaine (1 mg x cm(-2)) surrounded by a low tack pressure-sensitive adhesive backing layer. Thirty-two newborn infants of gestation 32-42 weeks (median 36 weeks), aged 3-18 days (median 6 days) were randomized to receive a tetracaine-containing patch or a placebo device applied to the dorsum of the hand 30 min before venepuncture to obtain blood samples. Pain was assessed in response to needle insertion using a validated adaptation of the neonatal facial coding score (NFCS) and the presence of crying.
Of 15 tetracaine-treated neonates, 14 (93%) presented little or no pain in response to the procedure compared with six of 17 (35%) who had the placebo patch applied (P=0.01).
The tetracaine patch produced effective pain relief during the venepuncture procedure in both term and pre-term infants. There were no adverse effects, either local or systemic. Background. Procedures such as venepuncture or heel prick are painful and may cause considerable stress to newborn infants. Topical local anaesthetics are effective for venepuncture but need to be applied for at least 60 min and the delivered dose will vary. We assessed a novel tetracaine‐based self‐adhesive patch in providing controlled local anaesthesia before venepuncture. Methods. A placebo‐controlled, double‐blind trial was conducted using a tetracaine patch formulated from hydroxypropylcellulose discs (0.283 cm2) containing tetracaine (1 mg cm–2) surrounded by a low tack pressure‐sensitive adhesive backing layer. Thirty‐two newborn infants of gestation 32–42 weeks (median 36 weeks), aged 3–18 days (median 6 days) were randomized to receive a tetracaine‐containing patch or a placebo device applied to the dorsum of the hand 30 min before venepuncture to obtain blood samples. Pain was assessed in response to needle insertion using a validated adaptation of the neonatal facial coding score (NFCS) and the presence of crying. Results. Of 15 tetracaine‐treated neonates, 14 (93%) presented little or no pain in response to the procedure compared with six of 17 (35%) who had the placebo patch applied (P=0.01). Conclusions. The tetracaine patch produced effective pain relief during the venepuncture procedure in both term and pre‐term infants. There were no adverse effects, either local or systemic. Br J Anaesth 2003; 91: 514–18 Background. Procedures such as venepuncture or heel prick are painful and may cause considerable stress to newborn infants. Topical local anaesthetics are effective for venepuncture but need to be applied for at least 60 min and the delivered dose will vary. We assessed a novel tetracaine‐based self‐adhesive patch in providing controlled local anaesthesia before venepuncture. Methods. A placebo‐controlled, double‐blind trial was conducted using a tetracaine patch formulated from hydroxypropylcellulose discs (0.283 cm2) containing tetracaine (1 mg cm–2) surrounded by a low tack pressure‐sensitive adhesive backing layer. Thirty‐two newborn infants of gestation 32–42 weeks (median 36 weeks), aged 3–18 days (median 6 days) were randomized to receive a tetracaine‐containing patch or a placebo device applied to the dorsum of the hand 30 min before venepuncture to obtain blood samples. Pain was assessed in response to needle insertion using a validated adaptation of the neonatal facial coding score (NFCS) and the presence of crying. Results. Of 15 tetracaine‐treated neonates, 14 (93%) presented little or no pain in response to the procedure compared with six of 17 (35%) who had the placebo patch applied (P=0.01). Conclusions. The tetracaine patch produced effective pain relief during the venepuncture procedure in both term and pre‐term infants. There were no adverse effects, either local or systemic. Br J Anaesth 2003; 91: 514–18 Procedures such as venepuncture or heel prick are painful and may cause considerable stress to newborn infants. Topical local anaesthetics are effective for venepuncture but need to be applied for at least 60 min and the delivered dose will vary. We assessed a novel tetracaine-based self-adhesive patch in providing controlled local anaesthesia before venepuncture. A placebo-controlled, double-blind trial was conducted using a tetracaine patch formulated from hydroxypropylcellulose discs (0.283 cm2) containing tetracaine (1 mg cm−2) surrounded by a low tack pressure-sensitive adhesive backing layer. Thirty-two newborn infants of gestation 32–42 weeks (median 36 weeks), aged 3–18 days (median 6 days) were randomized to receive a tetracaine-containing patch or a placebo device applied to the dorsum of the hand 30 min before venepuncture to obtain blood samples. Pain was assessed in response to needle insertion using a validated adaptation of the neonatal facial coding score (NFCS) and the presence of crying. Of 15 tetracaine-treated neonates, 14 (93%) presented little or no pain in response to the procedure compared with six of 17 (35%) who had the placebo patch applied (P=0.01). The tetracaine patch produced effective pain relief during the venepuncture procedure in both term and pre-term infants. There were no adverse effects, either local or systemic. BACKGROUNDProcedures such as venepuncture or heel prick are painful and may cause considerable stress to newborn infants. Topical local anaesthetics are effective for venepuncture but need to be applied for at least 60 min and the delivered dose will vary. We assessed a novel tetracaine-based self-adhesive patch in providing controlled local anaesthesia before venepuncture.METHODSA placebo-controlled, double-blind trial was conducted using a tetracaine patch formulated from hydroxypropylcellulose discs (0.283 cm(2)) containing tetracaine (1 mg x cm(-2)) surrounded by a low tack pressure-sensitive adhesive backing layer. Thirty-two newborn infants of gestation 32-42 weeks (median 36 weeks), aged 3-18 days (median 6 days) were randomized to receive a tetracaine-containing patch or a placebo device applied to the dorsum of the hand 30 min before venepuncture to obtain blood samples. Pain was assessed in response to needle insertion using a validated adaptation of the neonatal facial coding score (NFCS) and the presence of crying.RESULTSOf 15 tetracaine-treated neonates, 14 (93%) presented little or no pain in response to the procedure compared with six of 17 (35%) who had the placebo patch applied (P=0.01).CONCLUSIONSThe tetracaine patch produced effective pain relief during the venepuncture procedure in both term and pre-term infants. There were no adverse effects, either local or systemic. BACKGROUND: Procedures such as venepuncture or heel prick are painful and may cause considerable stress to newborn infants. Topical local anaesthetics are effective for venepuncture but need to be applied for at least 60 min and the delivered dose will vary. We assessed a novel tetracaine-based self-adhesive patch in providing controlled local anaesthesia before venepuncture. METHODS: A placebo-controlled, double-blind trial was conducted using a tetracaine patch formulated from hydroxypropylcellulose discs (0.283 cm(2)) containing tetracaine (1 mg x cm(-2)) surrounded by a low tack pressure-sensitive adhesive backing layer. Thirty-two newborn infants of gestation 32-42 weeks (median 36 weeks), aged 3-18 days (median 6 days) were randomized to receive a tetracaine-containing patch or a placebo device applied to the dorsum of the hand 30 min before venepuncture to obtain blood samples. Pain was assessed in response to needle insertion using a validated adaptation of the neonatal facial coding score (NFCS) and the presence of crying. RESULTS: Of 15 tetracaine-treated neonates, 14 (93%) presented little or no pain in response to the procedure compared with six of 17 (35%) who had the placebo patch applied (P=0.01). CONCLUSIONS: The tetracaine patch produced effective pain relief during the venepuncture procedure in both term and pre-term infants. There were no adverse effects, either local or systemic. |
| Author | Sittlington, N. M. Long, C. P. Halliday, H. L. Woolfson, A. D. McCafferty, D. F. Jones, D. S. |
| Author_xml | – sequence: 1 givenname: C.P. surname: Long fullname: Long, C.P. email: c.long@qub.ac.uk organization: School of Pharmacy, Queen's University Belfast, 97 Lisburn Road, Belfast BT9 7BL, UK – sequence: 2 givenname: D.F. surname: McCafferty fullname: McCafferty, D.F. organization: School of Pharmacy, Queen's University Belfast, 97 Lisburn Road, Belfast BT9 7BL, UK – sequence: 3 givenname: N.M. surname: Sittlington fullname: Sittlington, N.M. organization: Regional Neonatal Unit, Royal Maternity Hospital, Grosvenor Road, Belfast BT12 6BB, UK – sequence: 4 givenname: H.L. surname: Halliday fullname: Halliday, H.L. organization: Regional Neonatal Unit, Royal Maternity Hospital, Grosvenor Road, Belfast BT12 6BB, UK – sequence: 5 givenname: A.D. surname: Woolfson fullname: Woolfson, A.D. organization: School of Pharmacy, Queen's University Belfast, 97 Lisburn Road, Belfast BT9 7BL, UK – sequence: 6 givenname: D.S. surname: Jones fullname: Jones, D.S. organization: School of Pharmacy, Queen's University Belfast, 97 Lisburn Road, Belfast BT9 7BL, UK |
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| Copyright | 2003 British Journal of Anaesthesia 2003 2003 INIST-CNRS Copyright British Medical Association Oct 2003 |
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| Keywords | veins, venepuncture pain neonates anaesthetics local, tetracaine anaesthetics local, tetracaine; neonates; pain; veins, venepuncture Human anaesthetics local Percutaneous route Local anesthetic tetracaine; neonates; pain; veins Ester venepuncture Pain Newborn Local anesthesia Dosage form Puncture Vein Patch Tetracaine |
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| References | Woolfson, McCafferty, McGowan (bib15) 1992; 78 Elkman, Friesen (bib16) 1978 Barker, Rutter (bib2) 1995; 72 Jain, Rutter (bib11) 2000; 83 Ehrenström-Reiz, Reiz (bib4) 1982; 26 Jain, Rutter, Ratnayaka (bib12) 2001; 84 Tse, Barrington, Byrne (bib8) 1995; 12 Taddio, Stevens, Craig (bib5) 1997; 336 Stevens, Johnston, Taddio (bib7) 1999; 20 Woolfson, Mc Cafferty, Boston (bib10) 1990; 30 McCafferty, Woolfson, Boston (bib9) 1989; 62 McCafferty, Woolfson (bib14) 1993; 71 Larsson, Norman, Bjerring (bib6) 1996; 6 (bib1) 2002 Grunau, Oberlander, Holsti, Whitfield (bib3) 1998; 76 Grunau, Craig (bib18) 1987; 28 Woolfson, McCafferty (bib13) 1993; 94 Hadjistavropoulos, Craig, Grunau (bib17) 1997; 73 14970141 - Br J Anaesth. 2004 Mar;92(3):450; author reply 450-1 (10.1093/bja/aeg216_bib1) 2002 Taddio (10.1093/bja/aeg216_bib5) 1997; 336 Larsson (10.1093/bja/aeg216_bib6) 1996; 6 Tse (10.1093/bja/aeg216_bib8) 1995; 12 Jain (10.1093/bja/aeg216_bib11) 2000; 83 Jain (10.1093/bja/aeg216_bib12) 2001; 84 Grunau (10.1093/bja/aeg216_bib3) 1998; 76 Ehrenström-Reiz (10.1093/bja/aeg216_bib4) 1982; 26 Stevens (10.1093/bja/aeg216_bib7) 1999; 20 McCafferty (10.1093/bja/aeg216_bib14) 1993; 71 Barker (10.1093/bja/aeg216_bib2) 1995; 72 Elkman (10.1093/bja/aeg216_bib16) 1978 Grunau (10.1093/bja/aeg216_bib18) 1987; 28 McCafferty (10.1093/bja/aeg216_bib9) 1989; 62 Woolfson (10.1093/bja/aeg216_bib13) 1993; 94 Woolfson (10.1093/bja/aeg216_bib15) 1992; 78 Hadjistavropoulos (10.1093/bja/aeg216_bib17) 1997; 73 Woolfson (10.1093/bja/aeg216_bib10) 1990; 30 |
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| Snippet | Procedures such as venepuncture or heel prick are painful and may cause considerable stress to newborn infants. Topical local anaesthetics are effective for... Background. Procedures such as venepuncture or heel prick are painful and may cause considerable stress to newborn infants. Topical local anaesthetics are... BACKGROUND: Procedures such as venepuncture or heel prick are painful and may cause considerable stress to newborn infants. Topical local anaesthetics are... BACKGROUNDProcedures such as venepuncture or heel prick are painful and may cause considerable stress to newborn infants. Topical local anaesthetics are... |
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| SubjectTerms | Administration, Cutaneous anaesthetics local anaesthetics local, tetracaine Anesthesia, Local - methods Anesthetics, Local - administration & dosage Anesthetics. Neuromuscular blocking agents Biological and medical sciences Double-Blind Method Female Humans Infant, Newborn Intraoperative Complications - prevention & control Male Medical sciences neonates Neuropharmacology pain Pain - prevention & control Pain Measurement - methods Pharmacology. Drug treatments Phlebotomy - methods tetracaine Tetracaine - administration & dosage veins veins, venepuncture venepuncture |
| Title | Randomized trial of novel tetracaine patch to provide local anaesthesia in neonates undergoing venepuncture |
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