Effectiveness of sucrose analgesia in reducing pain responses in infants born to diabetic and non-diabetic mothers: A randomized controlled trial
| ISRCTN | ISRCTN23411530 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23411530 |
| ClinicalTrials.gov number | NCT00213213 |
| Secondary identifying numbers | MCT-63143 |
- Submission date
- 15/08/2005
- Registration date
- 15/08/2005
- Last edited
- 28/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Anna Taddio
Scientific
Scientific
Department of Pharmacy
Hospital for Sick Children
555 University Avenue
Toronto, Ontario
M5G 1X8
Canada
| Phone | +1 416 813 6235 |
|---|---|
| anna.taddio@sickkids.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | Effectiveness of sucrose analgesia in reducing pain responses in infants born to diabetic and non-diabetic mothers: A randomized controlled trial |
| Study objectives | 1. Administration of sucrose analgesia for every painful cutaneous procedure performed after delivery will result in less pain during the newborn infant screening test performed by venipuncture prior to hospital discharge 2. Sucrose analgesia for every painful cutaneous procedure will decrease pain responses in infants undergoing repeated heel lancing 3. Administration of sucrose for every painful procedure will not be associated with adverse effects 4. Administration of sucrose for every painful procedure will decrease anticipatory pain responses during venipuncture for the newborn screening test 5. There is a relationship between previous painful procedures and infant response during routine care procedures |
| Ethics approval(s) | Mount Sinai Hospital Research Ethics Board 17/06/2003 |
| Health condition(s) or problem(s) studied | Pain responses in infants born to diabetic mothers |
| Intervention | Group 1: 2 ml of 24% sucrose (weight/vol) 2 minutes prior to all noxious tissue-damaging cutaneous procedures Group 2: 2 ml of sterile water (placebo) 2 minutes prior to all noxious tissue-damaging cutaneous procedures |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Sucrose |
| Primary outcome measure | Infant pain score during venipuncture for the newborn screening test, as assessed by the Premature Infant Pain Profile (PIPP), or individual parameters of PIPP if there is divergence in response between parameters. |
| Secondary outcome measures | Secondary outcomes (effectiveness): 1. Effectiveness of sucrose for repeated heel lances 2. Effectiveness of sucrose in decreasing anticipatory pain responses during venipuncture 3. Determination of relationship between painful procedures and infant response during routine care procedures Secondary outcomes (safety): 1. Incidence of vomiting during drug administration 2. Oxygen saturation during drug administration 3. Serum Glucose concentrations in infants of diabetic mothers |
| Overall study start date | 01/07/2003 |
| Completion date | 31/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 240 |
| Key inclusion criteria | Include healthy newborn infants ≥36 weeks gestation (either sex). There are 2 study strata: infants born to mothers with diabetes (type 1, type 2, or gestational diabetes that is diet-controlled or insulin-dependent), and infants born to non-diabetes mothers with uneventful pregnancies. |
| Key exclusion criteria | 1. Admission to the neonatal intensive care unit (NICU) 2. Plan to undergo circumcision during the study period 3. Major congenital or neurological anomalies 4. Clinical diagnosis of birth asphyxia or seizures 5. Receiving analgesics or sedatives |
| Date of first enrolment | 01/07/2003 |
| Date of final enrolment | 31/07/2006 |
Locations
Countries of recruitment
- Canada
Study participating centre
Department of Pharmacy
Toronto, Ontario
M5G 1X8
Canada
M5G 1X8
Canada
Sponsor information
Hospital for Sick Children, Toronto (Canada)
Hospital/treatment centre
Hospital/treatment centre
555 University Avenue
Toronto, Ontario
M5G 1X8
Canada
"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-63143)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2008 | 28/01/2019 | Yes | No |
Editorial Notes
28/01/2019: Publication reference added
