Minimizing needle poke pain in newborn infants with a pain relieving cream and sugar water
| ISRCTN | ISRCTN82181559 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82181559 |
| Secondary identifying numbers | MCT-82947 |
- Submission date
- 22/08/2007
- Registration date
- 23/08/2007
- Last edited
- 18/04/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Anna Taddio
Scientific
Scientific
Department of Pharmacy and Child Health Evaluative Sciences
The Hospital for Sick Children
555 University Avenue
Toronto, Ontario
M5G 1X8
Canada
| Phone | +1 416 783 5263 |
|---|---|
| anna.taddio@sickkids.ca |
Study information
| Study design | Randomised, controlled, double-dummy, single-centre, three arm trial with study participant and investigator, caregiver, outcome assessor, and data analyst blinded. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Evaluation of liposomal lidocaine and oral sucrose for treatment of pain in newborn infants undergoing venipuncture: a randomised controlled trial |
| Study objectives | Public title: Minimising needle poke pain in newborn infants with a pain relieving cream and sugar water Hypothesis 1: Sucrose plus liposomal lidocaine will be superior to either agent alone in reducing pain during venipuncture. Hypothesis 2: Plasma levels of lidocaine will be below toxicologically significant levels (1 mcg/ml), providing objective evidence of safety. Hypothesis 3: Plasma levels of endomorphins-1,-2 will be higher in infants pre-medicated with sucrose versus lidocaine, confirming that sucrose exerts its analgesic effects via an opioid-mediated mechanism. |
| Ethics approval(s) | Ethics approval was gained from the Research Ethics Board of Mount Sinai Hospital Toronto, Ontario, Canada on August 03, 2007 (ref: 07-0099-A). |
| Health condition(s) or problem(s) studied | Newborns undergoing painful procedure |
| Intervention | Experimental arm one: 1 g of liposomal lidocaine to the dorsum of hand for 30 - 40 minutes prior to venipuncture and 2 ml of placebo water by mouth using a syringe over 1 - 2 minutes prior to venipuncture. Experimental arm two: 2 ml of 24% sucrose administered by mouth using a syringe over 1 - 2 minutes prior to venipuncture and 1 g of placebo liposomal lidocaine to the dorsum of hand for 30 - 40 minutes prior to venipuncture. Experimental arm three: both 1 g of liposomal lidocaine to the dorsum of hand for 30 - 40 minutes prior to venipuncture and 2 ml of 24% sucrose administered by mouth using a syringe over 1 - 2 minutes prior to venipuncture. Due to double dummy, all infants receive oral sucrose or water (placebo) and all infants receive liposomal lidocaine or placebo. Each baby gets one intervention (experimental arm 1, 2, or 3). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Liposomal lidocaine, oral sucrose |
| Primary outcome measure | Infant pain during venipuncture as assessed by facial grimacing response - the score will incorporate three facial actions: brow bulge, eye squeezed shut, naso-labial furrow, during venipuncture. |
| Secondary outcome measures | 1. Visual Analog Scale (VAS), during venipuncture 2. Cry duration, during venipuncture 3. Heart rate, during venipuncture 4. Number of attempts until procedure completion, from first needle poke to completion 5. Endomorphins -1, -2, levels, before and 10 minutes after sucrose/sucrose placebo administration 6. Procedure duration, from first needle poke to completion 7. Lidocaine levels, 5 - 15 minutes after the liposomal lidocaine cream/placebo cream is removed |
| Overall study start date | 01/08/2007 |
| Completion date | 28/02/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 330 |
| Key inclusion criteria | All healthy full-term (greater than 37 weeks gestational age) newborn infants (either sex) |
| Key exclusion criteria | 1. Neonatal Intensive Care Unit (NICU) admission 2. Asphyxia, seizures 3. Major birth defects (heart, brain, genetic syndrome) 4. Circumcised during study 5. Receiving analgesia/sedatives |
| Date of first enrolment | 01/08/2007 |
| Date of final enrolment | 28/02/2010 |
Locations
Countries of recruitment
- Canada
Study participating centre
Department of Pharmacy and Child Health Evaluative Sciences
Toronto, Ontario
M5G 1X8
Canada
M5G 1X8
Canada
Sponsor information
The Hospital for Sick Children (Canada)
Hospital/treatment centre
Hospital/treatment centre
c/o Ms. Julie Gibson, Manager
Clinical Research Office
555 University Avenue
Toronto, Ontario
M5G 1X8
Canada
| Phone | +1 416 813 8481 |
|---|---|
| julie.gibson@sickkids.ca | |
| Website | http://www.sickkids.ca/ |
"ROR" |
https://ror.org/057q4rt57 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-82947)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
