4% Ametop gel to reduce procedural pain in infants receiving a percutaneously inserted central catheter (PICC)
| ISRCTN | ISRCTN75884221 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75884221 |
| Secondary identifying numbers | FRN: 59754 |
- Submission date
- 18/11/2005
- Registration date
- 18/11/2005
- Last edited
- 06/03/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Brigitte Lemyre
Scientific
Scientific
401 Smyth Road
Ottawa
K1H 8L1
Canada
| blemyre@ottawahospital.on.ca |
Study information
| Study design | Randomised placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | How effective is 4% Ametop gel applied before a percutaneously inserted central catheter (PICC) in reducing procedural pain in infants: a randomised placebo controlled trial |
| Study hypothesis | To compare multidimensional pain scores as measured with the premature infant pain profile (PIPP) during insertion of a PICC in infants randomised to Ametop (Ametocaine) or placebo. |
| Ethics approval(s) | The Ottawa Hospital Research Ethics Board gave approval on the 27th June 2002. |
| Condition | Procedural pain in premature infants |
| Intervention | Treatment group: Amethocaine 4% gel, 1.5 g, applied for 30 minutes before the PICC insertion Placebo group: placebo gel (professional skin care lotion, Smith-Nephew), 1.5 g applied for 30 minutes before the PICC insertion |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ametop |
| Primary outcome measure | Premature Infant Pain Profile (PIPP) score at 1 minute |
| Secondary outcome measures | 1. PIPP scores at 1, 2, 3 and 4 minutes after the PICC 2. Physiological indicators of pain (HR, Sa02, BP, RR) at 1, 2, 3, 4, 5 and 10 minutes 3. Duration of cry in seconds from PICC insertion to recovery, number of attempts and success rate at inserting the PICC. 4. Safety: local skin reaction (redness, edema), significant changes in the complete blood count (CBC), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine before (within 48 hours) and after (within 48 hours) the intervention |
| Overall study start date | 18/12/2002 |
| Overall study end date | 26/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 54 |
| Participant inclusion criteria | 1. Born at greater than or equal to 24 weeks gestation 2. Infants 24 - 40 weeks gestational age, either sex 3. With skin considered in good condition (no burns or rash) 4. When less than 27 weeks gestation, must be greater than or equal to 48 hours of life 5. Considered stable by treating neonatologist 6. With informed consent by a parent or legal guardian |
| Participant exclusion criteria | 1. Skin considered immature 2. Suspected or proven significant central nervous system anomaly 3. Infants receiving opioids or sedatives at time of PICC insertion or in the previous 12 hours or infants receiving muscle relaxants 4. Infants with facial anomalies preventing typical facial expression of pain 5. Infants with sub optimal hepatic function (alanine aminotransferase [ALT] 2 x upper normal limit) or sub-optimal renal function 6. Parents or legal guardian have refused consent |
| Recruitment start date | 18/12/2002 |
| Recruitment end date | 26/07/2004 |
Locations
Countries of recruitment
- Canada
Study participating centre
401 Smyth Road
Ottawa
K1H 8L1
Canada
K1H 8L1
Canada
Sponsor information
Childrens Hospital of Eastern Ontario Research Institute (CHEORI) (Canada)
Hospital/treatment centre
Hospital/treatment centre
401 Smith Rd
Ottawa
K1H 8L1
Canada
| Website | http://www.cheori.org/ |
|---|---|
"ROR" |
https://ror.org/05nsbhw27 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: FRN: 59754)
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 | 03/05/2006 | Yes | No |
