Sucking and Sucrose as Pain Relief for Infants
Recruitment status was Not yet recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 7, 2008 | ||||||||
| Last Updated Date | December 8, 2008 | ||||||||
| Start Date ICMJE | March 2009 | ||||||||
| Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
reduced pain scoring [ Time Frame: 10 minutes ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00805623 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
better Parent's scoring to the child's behavior [ Time Frame: 10 minutes ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Sucking and Sucrose as Pain Relief for Infants | ||||||||
| Official Title ICMJE | Partial Blinded Controlled Study to Compare SucroseVs Water, With and Without Pacifier as Pain Reliever During Venous Puncture in Infants 3-12 Months Old | ||||||||
| Brief Summary | Sucking and sucrose have been shown to reduce pain during venous puncture in neonates. Our study is designed to see if sucking and sucrose relieve pain during venous puncture in infants age 3-12 months. |
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| Detailed Description | 100 infants age 3-12 months old without neurologic, developmental or cardio-respiratory impairment, needing venous puncture for IV access, or blood aspiration, will be randomly assigned to one of 2 groups - with or without pacifier. During the puncture, each patient with pacifier will receive either 1 cc of water or 1 cc of sucrose (the solutions prepared and marked blindly) . Each patient without pacifier 2 will receive 1 cc of water without pacifier,will receive either 1 cc of water or 1 cc of sucrose (the solutions prepared and marked blindly). FLACC pain score will be used for apin assessment before, during and after the puncture.Comparison of the four groups will be done after the end of the study. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Pain | ||||||||
| Intervention ICMJE | Dietary Supplement: sucrose
1 cc of sucrose 33.5% with or without pacifier
Other Name: no other name |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | October 2009 | ||||||||
| Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 3 Months to 12 Months | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00805623 | ||||||||
| Other Study ID Numbers ICMJE | 004994 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Schneider Children's Medical Center of Israel | ||||||||
| Study Sponsor ICMJE | Rabin Medical Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Rabin Medical Center | ||||||||
| Verification Date | December 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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