Table 2
Treatment comparison trials
| Reference | Type of drug exposure in utero | No of infants examined | Treatments | Randomisation | Outcome measure | Results |
|---|---|---|---|---|---|---|
| Kron et al34 | Methadone | 26 | Paregoric/phenobarbitone/diazepam | Not stated whether randomised | Sucking | Average sucking rate 31.1 sucks/min in paregoric group, 19.9 sucks/min in phenobarbitone group (p<0.05), and 39.6 sucks/min in control infants. Sucking rate 6.5 sucks/min in diazepam group versus 23.8 sucks/min in the controls |
| Finnegan et al32 | Methadone | 38 | Paregoric/phenobarbitone | Not randomised | Sucking | Average sucking rate 29.0 sucks/min in the paregoric treated, 24.1 sucks/min in the phenobarbitone treated infants |
| Kron et al33 | Diamorphine/methadone | 42 | Paregoric/phenobarbitone/diazepam | Not stated whether randomised | Sucking | Average sucking rate 30.5 sucks/min in the paregoric group (n=5), 19.4 sucks/min in the phenobarbitone group (n=28), 18.4 sucks/min in the diazepam group (n=6), and 23.2 in the controls (n=8) |
| Herzlinger et al36 | Diamorphine/methadone | 65 | Paregoric/diazepam | Not randomised | Seizures | Two of 48 paregoric treated infants and 5 of 12 diazepam treated infants had seizures (p<0.01) |
| Kandall et al8 | Diamorphine/methadone | 132 | Tincture of opium/diazepam | Not stated | Seizures | More convulsions seen in infants treated with diazepam (p<0.01) |
| Kandall et al38 | Methadone | 111 | Paregoric/phenobarbitone | Randomisation method not stated | Seizures | No infant had seizures in the paregoric group, 7 of 62 infants in the phenobarbitone group had seizures (p<0.025) |
| Pacifico et al37 | Diamorphine | 25 | Morphine/phenobarbitone + diazepam/morphine + phenobarbitone + diazepam | Not stated | Symptom control | Maximum withdrawal score 35 in the morphine treated group, 75 in the phenobarbitone + diazepam group and 100 in the phenobarbitone + diazepam + morphine group |
| Kahn et al39 | Diamorphine | 38 | Phenobarbitone/chlorpromazine | Randomisation method not stated | Symptom control | There was no significant difference in symptom control, as assessed by clinical observation in the 19 infants treated with chlorpromazine and the 19 treated with phenobarbitone |
| Finnegan et al44 | Opiate/polydrug | 139 | Paregoric/phenobarbitone/diazepam | Randomisation method not stated | Symptom control | Opiate exposed group; treatment success (as assessed by no need for a second therapeutic agent) 13 of 14 paregoric treated, 13 of 26 phenobarbitone treated and 0 of 5 diazepam treated infants. |
| Polydrug exposed group, treatment success; 11 of 18 paregoric treated, 54 of 61 phenobarbitone treated and 6 of 9 diazepam treated infants | ||||||
| Finnegan and Ehrlich43 | Opiate/polydrug | 300 | Paregoric/phenobarbitone/diazepam | Randomisation method not stated | Days to symptom control | Opiate exposed infants, mean days to symptom control 4.9 in paregoric treated, 6.7 in phenobarbitone treated and 9.5 in diazepam treated infants. |
| Polydrug exposed: 3.5 days in the phenobarbitone treated, 4.7 in the diazepam treated and 7 in the paregoric treated infants | ||||||
| Kaltenbach and Finnegan40 | Methadone | 69 | Paregoric/phenobarbitone/diazepam | Randomisation method not stated | Symptom control Developmental outcome at 6 months |
2 of 23 paregoric treated, 11 of 20 phenobarbitone treated and 10 of 10 diazepam treated infants required a second agent to control symptoms. |
| No significant difference in the developmental outcome at 6 months of the three groups | ||||||
| Madden et al42 | Diamorphine/methadone | 50 | Methadone/phenobarbitone/diazepam | Randomisation method not stated | Duration of treatment | Mean treatment duration: 11.7 days in methadone treated, 14.5 days in phenobarbitone treated and 10.2 days in diazepam treated infants |
| Carin et al41 | Methadone | 31 | Paregoric/phenobarbitone | Randomisation method not stated | Duration of treatment | Mean duration of treatment: 22 days in phenobarbitone treated infants, 17 days in paregoric treated infants (p<0.01) |
