Optimizing the Use of Morphine in Pre-Term Neonates
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Women's Studies |
| Therapuetic Areas: | Other, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/14/2017 |
| Start Date: | May 2005 |
| End Date: | November 2015 |
Optimizing Pain Treatment in Pre-Term Neonates
The purpose of this study is to improve the dosing of morphine in critically ill premature
neonates.
neonates.
The investigators hypothesize that identifying co-variates predictive of variability in
morphine disposition and/or response will provide the scientific basis for rationale and
individualized morphine dosing schemes in neonates and young infants.
60 preterm neonates ranging in gestational age from 22 to 32 weeks will be recruited from the
NICU. Stratification by gestational age will be done to ensure broad representation. The
decision to initiate morphine therapy will be based solely on clinical indications. Prior to
morphine dosing, a biochemical assessment of hepatic and renal function will be obtained. A
0.05 mg/kg loading dose of morphine will be given by an intravenous infusion over 30-minutes
in preterm neonates with a gestational age of less than 29 weeks, followed by a continuous
infusion of 0.005 mg/kg/h, whereas a loading dose of 0.1 mg/kg will be given in preterm
neonates with a gestational age of 29 weeks or more followed by a continuous infusion of 0.01
mg/kg/h. Pain assessment will be performed at baseline (prior to study medication
administration) and at .5, 1, 2, 4, 8, 12 and 24 hours after the dose. At each of these time
points infants will be videotaped for two minutes with two cameras. Videotapes will be scored
afterward using standard validated pain assessment tools for preterm infants.
morphine disposition and/or response will provide the scientific basis for rationale and
individualized morphine dosing schemes in neonates and young infants.
60 preterm neonates ranging in gestational age from 22 to 32 weeks will be recruited from the
NICU. Stratification by gestational age will be done to ensure broad representation. The
decision to initiate morphine therapy will be based solely on clinical indications. Prior to
morphine dosing, a biochemical assessment of hepatic and renal function will be obtained. A
0.05 mg/kg loading dose of morphine will be given by an intravenous infusion over 30-minutes
in preterm neonates with a gestational age of less than 29 weeks, followed by a continuous
infusion of 0.005 mg/kg/h, whereas a loading dose of 0.1 mg/kg will be given in preterm
neonates with a gestational age of 29 weeks or more followed by a continuous infusion of 0.01
mg/kg/h. Pain assessment will be performed at baseline (prior to study medication
administration) and at .5, 1, 2, 4, 8, 12 and 24 hours after the dose. At each of these time
points infants will be videotaped for two minutes with two cameras. Videotapes will be scored
afterward using standard validated pain assessment tools for preterm infants.
Inclusion Criteria:
- Preterm neonates of both genders and all races
- postnatal age less than 30 days
- an indwelling (peripheral or umbilical) arterial line, and
- a clinical indication for intravenous morphine administration
Exclusion Criteria:
- Neonates with severe asphyxia, grade III or IV intraventricular hemorrhage, major
congenital malformations/facial malformations, neurological disorders, and those
receiving continuous or intermittent neuromuscular blockers.
- clinical or biochemical evidence of hepatic and renal compromise (including systemic
hypoperfusion) or
- received drugs that are UGT2B7 substrates (including Lorazepam, ibuprofen, valproic
acid, naloxone and other morphine derivatives or propanolol)
We found this trial at
1
site
111 Michigan Ave NW
Washington, District of Columbia
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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