Pilot Study of Sucrose to Reduce Pain in Sick Babies

NCT01438008 | Terminated Phase 4 Results DMC

• 1 other identifier: 123942
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Small amounts of sweet tasting sugar water reduces pain in babies during painful blood tests and injections. The investigators do not know if sugar also reduces pain in babies already receiving a continuous infusion of opioid analgesics. This project will help determine if small amounts of sugar water reduce pain in babies already receiving a continuous infusion of opioid analgesic during a heel lance procedure or nasogastric/orogastric (NG/OG) tube insertions. The investigators hypothesize that infants who are receiving opioid analgesics will have lower pain scores during their blood tests (heel lance) or NG/OG tube insertion, when sucrose is given, compared to when water is given.

Conditions

Pain Due to Certain Specified Procedures

Keywords

Sucrose; Pain

Outcome Measures

Primary Outcomes (1)

• Premature Infant Pain Profile (PIPP)

  The Premature Infant Pain Profile (PIPP), a validated seven-indicator multidimensional pain assessment tool which is extensively used in neonatal pain research. The scale consists of seven indicators including assessment of gestational age and behavioural state (contextual indicators), heart rate and oxygen saturation (physiological indicators), and facial actions-brow bulge, eye squeeze, and nasolabial furrow (behavioural indicators), which are scored on a 0-3 scale and added for a total score of 0-21 Facial expression scores were also recorded on a 0-4 scale using a modified Neonatal Facial Coding System (NFCS) at 30, and 60 seconds following the beginning of the procedure. The modified NFCS coded for the presence (1) or absence (0) of the 4 most common facial expressions in response to acute pain (brow bulge, eye squeeze, nasolabial furrow, and stretch open mouth). High values on both of these scales represent worse outcome (i.e higher pain intensity).

  Baseline, day one of blood test

Secondary Outcomes (1)

• Total Crying Time

  Total crying time were recorded as a proportion of the time spent crying over the total length of procedure and/or in the 3 minutes that followed.

Study Arms (2)

Sucrose 24% po

EXPERIMENTAL

24% sucrose solution. The Children's Hospital of Eastern Ontario (CHOE) pharmacy department will provide syringes labeled "NICU Pain Relief Study" containing a maximum dose of 1 mL of a 24% sucrose solution

Drug: 24% sucrose po solution

Placebo po

PLACEBO COMPARATOR

The CHEO pharmacy department will provide a syringe labeled "NICU Pain Relief Study" containing a maximum of 1 ml dose of water (contents almost identical in color, consistency and odor to the sucrose solution) in identical packagings

Drug: Placebo po

Interventions

24% sucrose po solution DRUG

CHEO pharmacy department will provide syringes labeled "NICU Pain Relief Study" containing a maximum of 1 ml dose of a 24% sucrose solution. The maximum amount of the study solution will be administered according to the infant's gestational age and according to the hospital's Sucrose policy. The total amount of the study solution will be divided into a maximum of 5 aliquots and administered throughout the procedure at two minutes prior to the heel lance, immediately prior to the heel lance, and two-minutely intervals until completion of the procedure.

Also known as: CHEO Sucrose

Sucrose 24% po

Placebo po DRUG

CHEO pharmacy department will provide syringes labeled "NICU Pain Relief Study" containing a maximum of 1 ml dose of water (almost identical in color, consistency and odor placebo to the sucrose solution in identical packaging) The total amount of the study solution will be divided into 5 aliquots and administered throughout the procedure at two minutes prior to the heel lance, immediately prior to the heel lance, and two-minutely intervals until completion of the procedure

Also known as: Baxter sterile water

Placebo po

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Infants who are inpatients of the NICU:
• Who are receiving a continuous intravenous infusion of an opioid analgesic such as morphine or fentanyl at a maximum dose equivalent to 20 mcg/kg/hr of morphine and;
• Who require heel lance for medically required blood sampling or nasogastric/orogastric (NG/OG) tube insertions and;
• Who are eligible to receive sucrose as per the hospital's Sucrose policy for infants.

You may not qualify if:

• Infants less than 25 weeks gestation
• Infants with any injury to the skin where the probe needs to be placed
• Infants with an implanted defibrillator or pacemaker
• Infants with an injury affecting sympathetic nerve conduction
• Infants exposed to antenatal methadone
• Infants who, aside from being on opioid analgesics, are ineligible to receive sucrose as per the hospital's Sucrose policy38
• If the infant's mother wishes to breastfeed during the procedure
• Infants with known or suspected fructose intolerance
• Infants with spinal cord malformation (e.g. myelomeningocele and sacral teratoma) since these infant's response, and sensitivity to pain may differ from infants without spinal cord malformations
• Infants who are unconscious, heavily sedated and those with absent gag and/or swallow reflex
• Infants who are in isolation with only essential personnel caring for them
• To ensure there is no interaction effect of muscle relaxants, which may impact on infants' ability to mount a behavioural response to pain, assessments will not be conducted until a period of 24 hours since the previous muscle relaxant dose
• Parental language barrier (if unable to speak/understand French and/or English)

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead
• University of Ottawa: collaborator

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Related Publications (9)

• Barker DP, Rutter N. Exposure to invasive procedures in neonatal intensive care unit admissions. Arch Dis Child Fetal Neonatal Ed. 1995 Jan;72(1):F47-8. doi: 10.1136/fn.72.1.f47.

  PMID: 7743285 BACKGROUND

• Carbajal R, Rousset A, Danan C, Coquery S, Nolent P, Ducrocq S, Saizou C, Lapillonne A, Granier M, Durand P, Lenclen R, Coursol A, Hubert P, de Saint Blanquat L, Boelle PY, Annequin D, Cimerman P, Anand KJ, Breart G. Epidemiology and treatment of painful procedures in neonates in intensive care units. JAMA. 2008 Jul 2;300(1):60-70. doi: 10.1001/jama.300.1.60.

  PMID: 18594041 BACKGROUND

• Harrison D, Loughnan P, Manias E, Johnston L. Analgesics administered during minor painful procedures in a cohort of hospitalized infants: a prospective clinical audit. J Pain. 2009 Jul;10(7):715-22. doi: 10.1016/j.jpain.2008.12.011. Epub 2009 Apr 23.

  PMID: 19398379 BACKGROUND

• Johnston CC, Collinge JM, Henderson SJ, Anand KJ. A cross-sectional survey of pain and pharmacological analgesia in Canadian neonatal intensive care units. Clin J Pain. 1997 Dec;13(4):308-12. doi: 10.1097/00002508-199712000-00008.

  PMID: 9430811 BACKGROUND

• Porter FL, Anand KJ. Epidemiology of Pain in Neonates. Research & Clinical Forums 20(4): 9-16, 1998.

  BACKGROUND

• Simons SH, van Dijk M, Anand KS, Roofthooft D, van Lingen RA, Tibboel D. Do we still hurt newborn babies? A prospective study of procedural pain and analgesia in neonates. Arch Pediatr Adolesc Med. 2003 Nov;157(11):1058-64. doi: 10.1001/archpedi.157.11.1058.

  PMID: 14609893 BACKGROUND

• Taddio A, Katz J. The effects of early pain experience in neonates on pain responses in infancy and childhood. Paediatr Drugs. 2005;7(4):245-57. doi: 10.2165/00148581-200507040-00004.

  PMID: 16117561 BACKGROUND

• Grunau RE, Holsti L, Haley DW, Oberlander T, Weinberg J, Solimano A, Whitfield MF, Fitzgerald C, Yu W. Neonatal procedural pain exposure predicts lower cortisol and behavioral reactivity in preterm infants in the NICU. Pain. 2005 Feb;113(3):293-300. doi: 10.1016/j.pain.2004.10.020.

  PMID: 15661436 BACKGROUND

• Harrison D, Loughnan P, Manias E, Smith K, Johnston L. Effect of concomitant opioid analgesics and oral sucrose during heel lancing. Early Hum Dev. 2011 Feb;87(2):147-9. doi: 10.1016/j.earlhumdev.2010.11.008. Epub 2010 Dec 8.

  PMID: 21138786 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Recruitment for this study was difficult due to the tight inclusion criteria. Although consent was provided for 16 infants to participate, only 9 infants were randomized and studied the results may contribute to systematic review data.

Results Point of Contact

• Title: Dr. Denise Harrison
• Organization: Children's Hospital of Eastern Ontario

dharrison@cheo.on.ca

6137377600

Study Officials

• Denise Harrison, PhD

  Children's Hospital of Eastern Ontario

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endowed Chair in Nursing Care of Children, Youth and Families

Study Record Dates

• First Submitted: September 16, 2011
• First Posted: September 21, 2011
• Study Start: May 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 19, 2020
• Results First Posted: October 19, 2020

Record last verified: 2020-09

Locations

CA (1)